On January 5, 2010, The FDA issued a MedWatch safety and information report including information about a Class 1 recall of the Trailblazer Support Catheter device.

The recalled catheter is a medical device used to help with the delivery of solutions in the veins or arteries for the treatment of patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Specifically, this device may crack near the radiopaque marker band which may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.

Ev3 Endovascular, Inc., has sent a letter to all of its consumers summarizing the problem with the device and requesting the product be returned to their company.

Model Numbers recalled include: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.

Labels: Class 1 recall, FDA, MedWatch

McNeil Consumer Healthcare has voluntarily recalled all available product lots of Tylenol Arthritis Pain Caplet 100 count bottles. In November 2009, five lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials.
But consumers beware: this phenomenon is not unusual. Packaging not only acts as a barrier against contamination but it is also a source of contamination. In most cases, it is not a question of whether packaging components will leach into a product, it’s a question of how much. And pharmaceutical products are not immune to leaching. As a result, regulatory agencies collect information in order to document the safety margins of these food and drug “leachables”. Still, there is no set guideline among the governmental agencies. For instance, last year, the Canadian government banned the use of BPA in baby bottles as a precautionary measure against the risk that its presence could cause endocrine disruption in children--the FDA and other foreign agencies dispute the Canadian’s safety margins.
Still, scientists are trying to come up with a packaging material that prevents leaching of products. While a fool proof solution is yet to be found, the most successful anti-leaching products are available, at a price--the containers sometime cost several times the price of the components they replace.
In the meantime, pharmaceutical companies like McNeil Consumer Healthcare will continue to voluntarily recall their contaminated products. For all contaminated products, the consumer should stop using the product and contact the manufacturer for instructions on a refund or replacement.

Labels: drugs, FDA, products, recall

The FDA announced today that Norpramin (desipramine), an antidepressant made by Sanofi Aventis can cause disturbances in the heartbeat, including sudden cardiac death in people who have a family history of this or other heart rhythm disturbances. Also known as arrhythmia, the FDA says that this problem is often preceded by seizure in those taking Norpramin. MedWatch, the safety information arm of the FDA and the Sanofi Aventis sent this new warming to healthcare professionals. The new warning stated, if you take this drug, be sure to mention this warning to your doctor. Both Sanofi Aventis and the FDA said that Norpramin overdose is more likely to result in death than other tricyclic antidepressants.

According to the FDA, antidepressants are one of the most widely prescribed class of medications and many have side effects which include worsening depression, other mental or mood symptoms, suicidal thoughts or attempts and sometimes new or worsening anxiety, panic attacks, trouble sleeping, irritability, hostile or angry feelings, impulsive actions, severe restlessness, and very rapid speech. But, the heart rhythm disturbance at this time is unique to Norpramin and not associated with other antidepressants.

For more information regarding adverse events and deaths related to desipramine, contact: MedWatch at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or online at http://www.fda.gov/medwatch..

Labels: American Heart Association, desipramine, FDA, Norpramin

Vytorin is a combination of simvastatin (Zocor) and ezetimibe (Zetia). Vytorin reduces the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.

In August 2008, the U.S. Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of Vytorin and an increased risk of cancer and cancer-related death compared to placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. FDA has now completed its review of the data from the SEAS trial as well as a review of recent data from two large-scale ongoing cardiovascular trials with Vytorin. Based on the currently available information, FDA believes it is unlikely that Vytorin increases the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out.

FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of Vytorin or Zetia compared to other FDA-approved cholesterol lowering medications. Consumers should talk to their healthcare professional if they have any questions about Vytorin, Zetia, Zocor or the SEAS trial.

For more information about the FDA’s report, click here.

Labels: cancer, FDA, health care providers, Vytorin

There has been a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension. The recall is due to the potential presence of particulate matter found to be inert stainless steel particles. The particles could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.


Click here for the Medicines Company recall notice.

Labels: Cleviprex, FDA, recall

UPDATE: The FDA in a surprise decision declined to approve, Krystexxa, a gout drug manufactured by Savient Pharmaceuticals of East Brunswick, NJ.

The FDA declined the drug’s approval despite receiving a 14-1 recommendation for approval by its advisory committee in June. Generally, the FDA follows the recommendations of its advisory committees.

Savient plans to resubmit its application for approval Krystexxa early next year.

The FDA’s decision seems to be based on the drugs manufacturing process and not based on its effectiveness, according Savient’s press release.

The agency also concluded that a proposed change in the manufacturing process might make the drug sold to consumers different from the experimental drug tested in the clinical trial.

In addition, the FDA also said that Savient would need to have a program to monitor and reduce the side effects of the drug, particularly allergic reactions and cardiovascular problems.

Krystexxa was developed to treat gout, which is a painful form of arthritis. Gout is increasing because of richer diets, obesity and the aging of society.

The FDA typically does not discuss such regulatory decisions.

For more information please see:

Labels: FDA, Gout, Krystexxa, savient

Last month, we reported that the FDA was requiring stronger warnings on four types of botulinum toxin drug products. The most popular of the drugs affected by the warning change is Botox, which is commonly used in the United States for the off-label use of smoothing wrinkles. The FDA announced yesterday that all four of the botulinum toxin drug products now have a black box warning label on them.

The new warning cautions that the toxin used in the drugs, which is a variant of the bacteria that causes botulism, can migrate from the injection site to other areas of the body and can potentially cause symptoms similar to those experienced from botulism. The migration has mostly been reported when children with cerebral palsy are treated with the drug for muscle spasticity, an off-label use of the drug. In those children, the migration can cause severe adverse effects such as trouble swallowing and trouble breathing. No serious adverse effects have been reported from migration when the drugs are used for dermatologic purposes.

The new labels also caution health professionals that the four different types of botulinum toxin drugs are not interchangeable, because the units to measure each of the drugs are different. To help reduce the potential for dosing errors, the drugs have changed their established drug names (their generic names).

For more information, see the FDA Press Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm

See the Drug Safety Information for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174949.htm

See the update of Safety Review for Patients and Providers at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174959.htm

Labels: Botox, botulinum toxin, botulism, cerebral Palsy, FDA

On Friday, the FDA approved a new drug, Onglyza, to treat Type 2 diabetes. Onglyza, a once-daily tablet for adults with Type 2 diabetes, is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a post-market study that will specifically evaluate cardiovascular safety in a higher risk population.

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Delaware.

For more information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174780.htm

Labels: blood sugar, clinical trials, diabetes type 2, FDA, Onglyza

The FDA has filed for a consent decree of permanent injunction that prohibits Teva Animal Health Inc., from manufacturing and distributing adulterated veterinary drugs. The injunction will prevent the defendants from manufacturing and distributing veterinary drugs until they meet the current Good Manufacturing Practice (cGMP) standards and receive FDA approval.

“Good manufacturing practice standards are the backbone of product quality and the instrument on which the FDA relies most heavily for assurance that veterinary drug products are safe and effective,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

From 2007 and 2009, FDA inspections revealed significant cGMP violations at Teva Animal Health's facilities in St. Joseph, Mo.

Under the terms of the consent decree, Teva Animal Health will not be able to begin manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established. In addition, an independent expert must inspect the facilities and procedures and certify that they comply with cGMP. Finally, the FDA will inspect Teva Animal Health's facilities as needed before authorizing the company to resume operations.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

If Teva Animal Health further violates the consent decree, they are subject to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to $7.5 million per year.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174880.htm

Labels: drugs, FDA, good manufacturing, MO, St. Joseph, Teva Animal Health, veterinary

The FDA notified consumers and healthcare professionals yesterday not to use body-building products marketed as containing steroids or steroid-like substances. The products are marketed for increasing muscle mass and body building and are advertised as alternatives to anabolic steroids. The FDA warns that these products are marketed as dietary substances, but they are instead unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said the FDA’s commissioner, Dr. Margaret Hamburg. The agency cent a letter to American Cellular Laboratories Inc., saying it markets and distributes drugs labeled as dietary supplements which are in fact unapproved drugs. To be a dietary supplement, a product has to contain one or more dietary ingredients, such as vitamins or minerals.

Over the past two years, the FDA has received 5 adverse event reports through its MedWatch reporting system directly related to steroid containing products. Some of the events reported include serious liver injury. No deaths were reported. The products affected by the warning are marketed by American Cellular Laboratories, Inc. and include: TREN-Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40 Xtreme.

For more information, see the FDA News Release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174060.htm

See the MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173983.htm

See the FDA Consumer Report at:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173739.htm

See the article from CNN’s Website at:
http://www.cnn.com/2009/HEALTH/07/28/body.building.steroids/index.html?eref=rss_health

Labels: ACLU, body-building, FDA, liver damage, steroids

Silver dental fillings containing mercury are safe for use by adults and children ages 6 and above, the Food and Drug Administration. Only people who are allergic to mercury should avoid that type of filling.

After reviewing more than 200 scientific studies, the agency concluded that mercury vapor released by the filling was not enough to cause brain damage. Still, the agency classified the fillings as a Class II or moderate risk medical device.

A Class II label allows the FDA to impose special controls to provide reasonable assurance of the safety and effectiveness of the device.

The special controls include: a warning against the use of dental amalgam in patients with mercury allergy; a warning that dental professionals use adequate ventilation when handling dental amalgam; and a statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor.

The FDA has previously warned on its web site about the filling’s potential risks for fetuses, breast-feeding infants and children younger than 6. The findings showed that the fillings do not expose those groups to mercury levels considered unsafe by the Environmental Protection Agency, but added that there were few studies on the effects of mercury in fillings on children under 6.

The filling, scientifically known as a dental amalgam, is a mixture of liquid mercury and a powdered alloy. The mercury and the alloy had previously been classified separately. The mercury component was considered a Class I or low risk device.

Silver dental filling is the least expensive type of filling, used in roughly a third of procedures to replace tooth decay.

For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm

Labels: cavity, dental, dental amalgam, Dentist, FDA, filling, mercury

The FDA approved the ordinary seasonal flu vaccine on Monday and stated that Americans should plan to get vaccinated. Vaccines against seasonal flu usually become available in September or October and flu experts say it is worthwhile to be immunized as late as January, since the U.S. influenza season usually peaks in February.

This year will be different since the new H1NI swine flu virus has been circulating and companies are working to make a separate vaccine against the pandemic strain. In a statement released by the FDA, they stated, “The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization on June 11, 2009.” The FDA further stated that, “Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine.”

According to the United States government, between 5 and 20 percent of the United States population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Six companies manufacture the seasonal flu vaccine for the United States: GlaxoSmithKline Plc, ID Biomedical Corp, Novartis AG, Sanofi-Aventis SA, AstraZeneca, and CSL Ltd.
For more information see: http://www.msnbc.msn.com/id/32010750/ns/health-cold_and_flu/

Labels: FDA, flu vaccine, government, influenza, pandemic, swine flu

Luv N’ Care Ltd, a Monroe, Louisiana based corporation, is initiating a recall of their gel-filled teethers with the brand names “Nuby”, “Cottontails”, and “Playschool.” The products are being recalled because of a finding by the FDA that two lots contained Bacillus subtilis and Bacillus circulans in the gel. While generally these bacteria do not cause illness in adults, children have weakened immune systems and can get sick if the teether is punctured and the gel is accidentally ingested.

If the bacteria are ingested by a child, it can cause stomach pain, vomiting, diarrhea, and sometimes more serious disease. However, no illnesses have been reported to date. The company distributed the products through retail outlets nationwide, and have also been marketed on the internet. The company has discontinued production of the teethers and is urging consumers to return the teethers for a full refund.

The recall involves the following products:
UPC code Brand Name 48526-00451 Nuby48526-00452 Nuby48526-00453 Nuby48526-00454 Nuby48526-00455 Nuby48526-00459 Nuby48526-00467 Nuby48526-00472 Nuby48526-00473 Nuby48526-00482 Nuby48526-00483 Nuby48526-00487 Nuby48526-00490 Nuby48526-00519 Nuby48526-00521 Nuby41520-87115 Cottontails50428-91511 Playschool41520-91660 Cottontails

Consumers with questions may contact the company at 1-800-256-2399 ext. 3106 between 8 a.m. and 5 p.m. central time.
Adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.
For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172712.htm

See the FDA press release at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172713.htm

Labels: bacillus subtilis, bacteria, FDA, Luv N Care, Playschool, teething

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.
Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.
The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.
For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.

For more information please see:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

FDA takes Steps to Fight Counterfeit Drugs

Labels: All Star Game, Counterfeit, drugs, FDA, July 15

This drug is reportedly linked to Michael Jackson’s Death

Two tainted lots of a generic version of a drug reportedly taken by Michael Jackson have been recalled by the drug maker. Teva Pharmaceuticals has voluntarily recalled Propofol, the generic version of Diprovan, which is a powerful anesthetic and sedative.

However, no link has been established between the drug and the singer's death. Jackson died June 25 of cardiac arrest. The CDC is not involved in the investigation into Jackson's death.

The CDC issued a health advisory Monday, stating two lots of a generic version of the drug had tested positive for endotoxin, a contaminant.

There are 40 reported events of patients developing high fevers and muscle aches after being injected with the drug. All of the people who had taken propofol recovered; only one was hospitalized and that patient was quickly discharged.

At high doses, endotoxin can lower blood pressure and cause much more serious reactions. A decrease in blood pressure can cause problems with the heart, said Dr. Arjun Srinivasan, the chief investigator on the recall for the Centers for Disease Control and Prevention.

Teva Pharmaceuticals is working with the FDA to determine how the contamination occurred and is voluntarily recalling the affected lots.

According to Teva, about 57,000 100 ml vials were recalled. With regard to the Jackson investigation, spokeswoman Denise Bradley said, “I can say the DEA did contact us about a specific lot number, and that lot number is not from the two we are recalling."

The affected lots are 31305429B and 31305430B. Healthcare professionals are advised to immediately stop using these lots of propofol.

The Associated Press and the Los Angeles Times, citing unidentified sources, have reported that police found the drug Diprivan, a brand-name version of propofol, among Jackson's medicines.

The FDA requests reports of adverse events with propofol are made to MedWatch. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact.

The FDA can be contacted via:

• https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information please see: CNN's Reports on the Events or CDC Advisory Letter to Health Care Professionals

Labels: CDC, chills, diprovan, endotoxin, FDA, fever, Michael Jackson, Propofol, recall, Teva

The FDA announced yesterday that is requiring a label change for certain immunosuppressant drugs. The FDA conducted an analysis of its Adverse Event Reporting System on MedWatch and discovered a link between BK virus-associated nephropathy and the use of certain immunosuppressant drugs. The required label change is to reflect that immunosuppressed patients are at an increased risk for opportunistic infections, such as activation of latent viral infections, including the BK virus-associated nephropathy. The drugs affected by the label change are used to protect against the rejection of organs when a patient undergoes an organ transplant. The occurrence of BK virus-associated nephropathy has been primarily observed in renal (kidney) transplant patients.

The immunosuppressant drugs affected by the required label change are:
Sirolimus (brand name Rapamune)
Cyclosporine (brand name Sandimmune, also generics are affected)
Cyclosporine (brand name Neroral, also generics are affected)
Mycophenolate mofetil (brand name Cellcept, also generics are affected)
Mycophenolic acid (brand name Myfortic)

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. The association of BK virus-associated nephropathy has previously been linked with another drug, tacrolimus (brand name Prograf). The label changes that the FDA announced for the above listed drugs have already been included on the label of Prograf. The FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA is urging health care professionals and patients to continue to report adverse events from the use of immunosuppressant drugs to the FDA’s MedWatch Adverse Event Reporting System.

For more information, see the FDA’s MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm

See the FDA Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm

See the Information for Healthcare Professionals at:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm

Labels: BK virus, BK virus-associated nephropathy, Cellcept, cyclosporine, FDA, immunosuppressant, mycophenolate, Myfortic, Neroral, Rapamune, renal transplant, Sandimmune, sirolimus

The Food and Drug Administration approved a blood thinner from Eli Lilly, of Indianapolis, but the drug must have a black box warning of its risk of causing bleeding. The boxed warning is reserved for issues that can cause serious injury or death.

Lilly’s Effient is the first real competition to the blood thinner Plavix, which is made by Sanofi-Aventis and Bristol-Myers Squibb.

A Lilly study of more than 13,000 patients found that thought Effient prevented more heart attacks than Plavix, it caused more internal bleeding. Company studies showed 7 percent of patients taking Effient had nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death for the drugs were similar.

The F.D.A. approval of Effient was 18 months long it weighed the drug’s benefits and risks.

Effient should not be taken by patients with a history of bleeding, stroke or who are undergoing an operation.

Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. Effient is approved only for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.

For more information please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm

Labels: angioplasty, approval, bleeding, blood thinner, Effient, FDA, heart attack, plavix

The FDA yesterday elevated the recall on the BiPAP Focus Non-Invasive Ventilator System to a Class I status. The ventilator, manufactured by Respironics California, Inc., is being recalled for power supply failures. The device is used by healthcare professionals to treat adult patients who have advanced lung disease or difficulty breathing. In the ventilator, a wiring problem may cause a power surge which can exceed the power supply capacity, causing the power supply to lose power and the ventilator to not function properly.

Class I recalls are the most serious type of recall and involve products that the use of can cause serious injury or death. The particular product being recalled is model number PCM120PS18-2315P. Customers or health care providers can contact Respironics Customer Service at 1-877-387-3377.

For more information, see the MedWatch safety information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm

See the Recall Notice from the FDA at:
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm171194.htm

Labels: Class 1 recall, FDA, Lung disease, Respironics, Ventilator

Labels: bottled water, EPA, FDA, filter, raven, tap water

The FDA has decided to let painkillers Darvocet, Darvon and their genetic versions stay on the market but has ordered stronger warning against deadly overdoses. Darvocet, which is known generically as propxyphene, is widely used in the U.S. even though doctors consider it to be a “weak pain reliever”.

The group Public Citizen petitioned the FDA to ban the drug in the United States, saying that the small benefit didn’t justify a risk that was adding up to several hundred deaths a year. Britain banned the drugs several years ago citing a trail of suicides and accidental overdoses.
However, in the United States the FDA only ordered that a stern box warning be placed on the drug’s label, and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.
Public Citizen is considering whether to appeal the FDA’s decision regarding Darvocet and Darvon.

“This is a reckless decision on the part of the FDA unless they believe Americans are resistant to the death- causing properties of this drug in a way that Europeans and the people in the U.K aren’t,” said Public Citizen’s Dr. Sidney Wolfe. “You’ve got a drug which has a barely perceptible benefit and a very clear risk.”

For more information see: http://www.msnbc.msn.com/id/31785225/ns/health-more_health_news/

Labels: Darvocet, Darvon, FDA, painkillers, Public Citizen

The FDA approved Alimta yesterday, the first maintenance therapy drug available to treat advanced lung cancer. Patients are often treated with maintenance therapy to prevent the cancer from spreading once the tumor itself is shrunk or has been responsive to chemotherapy. Alimta disrupts the production of B-vitamin folate in certain cells, a necessary ingredient for cell replication.

When asked on his thoughts about Alimta, Dr. Richard Pazdur, MD, and director of the FDA’s Drug Evaluation and Research Office of Oncology Drug Products stated, “This drug represents a new approach in the treatment of advanced non-small cell lung cancer. Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.”

Alimta, manufactured by Eli Lily & Co. of Indianapolis, initially was approved in 2004 for the treatment of patients with mesothelioma, a cancer frequently related to asbestos exposure. The drug was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.

For more information, see the FDA News Release at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170515.htm

Labels: Alimta, cancer, chemotherapy, FDA, maintenance therapy, Mesothelioma

The FDA warns consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials because of suspected product tampering. Both products are recalled.

A utility knife blade was found in a vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada. A second blade was found in one vial of New Whey liquid products, manufactured and sold in the United States. There are no reported injuries.

Both Hardcore Energize Bullet and New Whey liquid products are manufactured by Protica Inc., of Whitehall, Pa.

Hardcore Energize Bullet liquid products are recalled by distributor iSatori Technologies of Golden, Colo. The liquid is packaged in 2.9 ounce clear vials. The flavors affected are: Blue Rage and Black Rush.

The affected lots for the Blue Rage liquid product are: 1961, 1962, and 1794. The affected lot for the Black Rush liquid product is 1963.

New Whey liquid products are recalled by distributor IDS of Oviedo, Fla. The liquid is packaged in 2.9 ounce clear vials. The flavors affected are New Whey Fruit Punch 25g and New Whey Blue Raspberry 42g.

The affected lot for the New Whey Fruit Punch liquid product is 1960. The affected lot for the New Whey Blue Raspberry liquid product is 1944.

The FDA encourages consumers and healthcare professionals to report adverse events and product quality issues to the FDA.

The FDA can be contacted via:

• https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170500.htm

Labels: engery drink, FDA, hardcore, hardcore energize bullet, knife blade, new whey, recall

FDA acknowledges four recent studies that observed the use of the insulin, Lantus and possible risk for cancer. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. See http://www.diabetologia-journal.org/cancer.html.

Currently, the FDA recommends that patients consult their doctor before stopping their insulin therapy. Patients should not stop their therapy on their own. Uncontrolled blood sugar levels can pose both immediate and long-term serious adverse effects.

Similar to human insulin, Lantus is used to control blood sugar in people with Type 1 and Type 2 diabetes. Lantus is a long-acting insulin that is only approved for once-a-day dosage delivered by under the skin injections.

In all four studies, the length of patient follow-up was shorter than what is necessary to evaluate for cancer risk from drug exposure. Further, the studies were inconsistent within themselves and with each other, which raises the question if there really is an association between Lantus and cancer. Additionally, differences in patient characteristics in the various treatment groups may have contributed to a finding of increased cancer risk.

Nonetheless, FDA is reviewing the safety data for Lantus to better understand the risk, if any, for cancer associated with use of Lantus. FDA is also communicating with Lantus if any additional studies are needed to evaluate the safety and efficacy of Latus.

FDA requests that any adverse events associated with Lantus be reported to their MedWatch program.

he FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders

Labels: cancer, diabetes, FDA, insulin, Lantus

Beginning yesterday, the FDA gathered more than 35 experts in Maryland to discuss their options of how to prevent overdoses of over-the-counter acetaminophen. Acetaminophen is the pain and fever reducing active ingredient in drugs such as Tylenol and Excedrin. Acetaminophen overdose is the leading cause of liver failure in the United States. We reported in May that the FDA was going to require acetaminophen to have stronger labels. The two day meeting that the FDA began yesterday was to discuss all of the alternatives in order to cut back on overdoses, including stronger warnings or pulling products from the shelve all together.

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose. The FDA says patients often pair them with a pure acetaminophen medication, like Tylenol, exposing themselves to unsafe levels of the drug. Manufacturers of the drugs argue that the FDA is overemphasizing the dangers of acetaminophen. Only 10% of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association. The majority of deaths were caused by either single-ingredient drugs or prescription strength combination drugs like Endo Pharmaceuticals Holdings Corp.'s Percocet, which combines oxycodone and acetaminophen.

Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80% of the market comprised of over-the-counter products. Manufacturers of the drugs also warned panelists that any new restrictions on acetaminophen would force patients to switch to nonsteroidal anti-inflammatory drugs (NSAIDS), which carry risks of gastrointestinal bleeding and sometimes fatal kidney injury. In response, the FDA has stated that its intent is only to reduce liver injury, not to decrease acetaminophen use or encourage the use of NSAIDS.

For more information, see the St. Louis Post-Dispatch article at:
http://www.stltoday.com/stltoday/news/stories.nsf/sciencemedicine/story/4CDAC39AECC98D31862575E50017457A?OpenDocument

Labels: Acetaminophen, Excedrin, FDA, liver failure, NSAIDS, Tylenol

Roche Holding AG, one of biggest makers of cancer drugs, pulled its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease. Roche notified the FDA today that it would be withdrawing Accutane after a reevaluation of the product showed it faced serious challenges from generic competitors, company officials stated.

About 13 million people have used Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

The company faces as many as 5,000 personal injury claims over Accutane, said Michael Hook, a Pensacola, Florida based attorney, who won a $10.5 million verdict against the drug maker over the medicine in April 2008. “We’ve been winning the cases with the drug still on the market, but this move certainly isn’t going to hurt us going forward”, Hook said in an interview today.

Use of Accutane has been linked to birth defects and depression. Users allege that the drug maker failed to properly warn that the medicine could cause inflammatory bowel disease.

For more information see: http://www.bloomberg.com/apps/news?pid=20670001&sid=aRyzfbTsj3h8

Labels: acne, cancer drug, FDA, Florida, personal injury

On June 25, 2009, Health Canada, an organization similar to the FDA, announced new restrictions fro Piroxicam. The agency concluded that piroxicam should no longer be used to treat short-term pain and inflammation because of an increased risk of serious skin reactions and gastrointestinal problems relative to other similar drugs.

Piroxicam is a prescription drug in the family known as non-selective non-steroidal anti-inflammatory drugs (NSAIDs), and is used to relieve pain and inflammation.

The risks associated with its use as a treatment for acute, short-term pain do not outweigh the benefits relative to alternative treatment options. Piroxicam should still be used for chronic pain and inflammation in patients suffering from certain types of chronic arthritis.

The product’s labeling will be updated to reflect the new restrictions. Health Canada is currently working with the manufacturers of these drugs to revise the product monographs. Patients with concerns should contact their physicians.

The FDA made a similar announcement regarding all NSAIDs in May 2009.

Please report any adverse reactions associated with Piroxicam to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm150314.htm

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_102-eng.php

Labels: FDA, inflammation, NSAID, pain, Piroxicam

The American Heart Association (AHA) released an advisory that a “clot-busting” drug can be effective for an extra 90 minutes longer than what the FDA has approved the drug for. The drug, called recombinant-tissue plasminogen activator, or rt-PA, is one that can be administered to stroke patients when they enter the hospital and will immediately dissolve clots, possibility preserving patients’ ability to function. The FDA has for the last ten years has set a limit on allowing the drug to only be used within 3 hours of a patient suffering a stroke. The AHA advisory, however, shows that the drug can still be effective on patients if it is administered with 4.5 hours of a patient suffering a stroke.

Rt-PA works almost instantly dissolving clots, which account for more than 85% of strokes. The drug is in effective for the 15% of strokes caused by a burst blood vessel in the brain. Once a stroke patient comes to the emergency room, it can take up to 45 minutes to determine what the cause of the stroke is, often times brining the patient out of the FDA-approved 3 hour window for the drug. A further challenge is getting people to the emergency room on time. Fewer than 25% of people recognize their stroke symptoms soon enough to even get to the hospital in time to be administered the drug.

Using the drug according to the AHA advisory is an off-label use of rt-PA. It is legal to use drugs for an off-label use after the drug has been approved by the FDA, but it is much more risky. This advisory gives doctors that administer the drug past the 3 hour time limit support. The advisory also states that people that aren’t suited for use of the drug after 3 hours are those who are older than 80, those who are on blood thinners for a cardiovascular condition, and those who have diabetes or previous strokes. Barnes-Jewish Hospital has been administering the drug for the extra 90 minute window since the beginning of the year.

For more information, see the St. Louis Post-Dispatch Article at:
http://www.stltoday.com/stltoday/lifestyle/stories.nsf/healthfitness/story/958DD75F122A2F3E862575DF00742BEF?OpenDocument

Labels: American Heart Association, Barnes-Jewish, clot-buster, FDA, rt-PA, stroke

Labels: emergency contraceptive, FDA, Plan B, pregnancy, prescription

The public interest group, Judicial Watch, recently obtained records from the FDA documenting 28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV). In 2007, there were just 19 deaths. The total number of Gardasil associated deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 adverse events in 2008, of which 1,061 were considered serious, and 142 considered life threatening.

Of the 47 reported deaths, 41 occurred within a month of receiving the vaccine and of those 17 were within two weeks or receiving the vaccine. In most of the deaths, the cause is still unknown.

Sixty-two developed genital warts after receiving the vaccine. Gardasil, which is designed to prevent two strains of genital warts, is not supposed to react with other HPV strains.

One woman developed full-blown cervical cancer within 15 months from the completion of the Gardasil vaccination. The patient now has the difficult choice of having a hysterectomy or receiving treatment in hopes that she may be able one day to conceive children.

Please report any adverse events associated with Gardasil to the FDA.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.judicialwatch.org/news/2009/jun/new-fda-records-obtained-judicial-watch-indicate-28-deaths-related-gardasil-2008

Labels: death, FDA, Gardasil

President Obama signed legislation Monday that gives the FDA the power to regulate the tobacco industry. The bill, called the Family Smoking Prevention and Tobacco Control Act, gives the Food and Drug Administration the power to regulate how tobacco is manufactured, marketed, and sold. The Act gives the FDA the authority to ban candy and fruit flavored cigarettes, often thought to be especially enticing to youths. The Act also prohibits tobacco companies from marketing their cigarettes as “light”, “mild”, or “low-tar”. Also as a result of the Act, tobacco companies will be required to lower the level of nicotine in their cigarettes and advertising for tobacco products will be restricted.

When signing the bill, the President noted that despite the fact that the percentage of Americans who smoke has significantly decreased over the last few decades, about 400,000 people still die every year from tobacco related illnesses. Health care costs for tobacco related illnesses also cost about $100 billion a year.

For more information, see:
The CNN article:
http://www.cnn.com/2009/POLITICS/06/22/obama.tobacco/index.html?eref=rss_health

Labels: cigarettes, Family Smoking Prevention and Tobacco Control Act, FDA, Obama, tobacco

Labels: e.coli, FDA, nestle cookie dough recall, nestle recall

UPDATE: A federal advisory committee on Tuesday recommended approval of a drug developed by Savient Pharmaceuticals to treat severe cases of gout. The Advisory Committee's recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Savient has submitted for Krystexxa. The FDA usually follows the advice of its advisory committees.

The 14-to-1 vote for approval reflected a general consensus that the effectiveness of the drug in relieving severe pain and disability outweighed the risk of allergic reactions and suggestions that it could cause cardiovascular problems.

Gout is an exceedingly painful form of arthritis that afflicts the big toe and other joints. It is estimated that two million to six million Americans have gout. Krystexxa is intended for only about 50,000 Americans with gout who cannot be treated with other drugs.

In clinical trials, the drug worked for about 40 percent of patients, in some cases bringing marked improvement.

The small size of the studies made it impossible to determine whether an increase in heart problems among those taking Krystexxa was caused by the drug or was just chance. If the drug is approved, the advisory panel recommends further studies on Krystexxa safety and its use carefully restricted to those not helped by other therapies.

A handful of gout patients testified that the drug had dissolved unsightly and disabling lumps on their bodies, called tophi, and allowed them to walk or use their hands again. Savient paid for hotels and transportation for some patients to attend the meeting, which was in Silver Spring, Md.

Though Savient has not named a price for their drug, analysts estimate treatment to cost tens of thousands of dollars a year.

The FDA is expected to make a decision as to whether to grant marketing approval for Krystexxa by August 1, 2009.

For more information please see: http://investor.savient.com/ReleaseDetail.cfm?ReleaseID=390150

Labels: cardiovascular, FDA, Gout, Krystexxa, treatment

Yesterday on June 15, 2009 Hi-Tech Pharmaceuticals recalled its weight loss supplement Stamina-Rx. Stamina-Rx contains benzamidenafil, an undeclared and not FDA-approved ingredient.

Hi-Tech Pharmaceuticals, Inc. of Norcross, GA manufacturers Stamina-Rx.

On May 1, 2009, the FDA notified Hi-Tech that its lab analysis of Lot 08141578, Exp. 9/10 of Stamina-Rx contains − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. PDE5 inhibitors, like FDA-approved sildenafil, tadalafil, and vardenafil treat erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers. Benzamidenafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling posted on certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with the FDA since September 23, 2003. In accordance with the Decree, the FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 the FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. For more information regarding the recall contact: Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

Please report any adverse events associated with Stamina-Rx to the FDA’s MedWatch program.

The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Safety/Recalls/ucm167139.htm

Labels: diabetes, FDA, Hi-Tech, Stamina-Rx, viagra

The FDA announced today a warning concerning loss of smell associated with the use of the over the counter cold remedy, Zicam. The FDA has received reports of over 130 cases of ansomia, or loss of smell, associated with the use of Zicam. Zicam is an intranasal product that contains zinc. The agency urged consumers to quit using the product and to throw away any Zicam that they may already have at home. Zicam is marketed as an over the counter cold remedy that can shorten the length and severity of the common cold.

The effected products are:
• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21) (this has already been discontinued)

The products are sold in retail stores and pharmacies without a prescription. Zicam Kids Size has already been discontinued, but the FDA is concerned that some people may still have the product in their homes. The FDA has special concerns about the use of zinc in children. The anosmia that can be experienced by consumers can either be temporary or permanent.

The FDA sent a warning letter to Matrixx Initiatives, the manufacturer of Zicam, stating that they can no longer sell their product without FDA approval and that their warnings regarding the loss of the sense of smell are adequate. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance.

Anyone who has used this product and experiences a loss of the sense of smell should report the incident to their doctor right away. Any problems should also be reported to MedWatch. Consumers can report problems to MedWatch either online through the FDA’s website, or they can call at 1-800-FDA-1088.

For more information, see the FDA Consumer Update:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm166931.htm

The FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

The FDA Safety Information
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm

The FDA Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm166059.htm

Labels: anosmia, Common cold, FDA, MedWatch, zicam

FoodScience Corporation of Essex Junction, Vermont voluntarily recalled approximately 1, 250 bottles of its Children’s Multi- Vitamins. The recalled was initiated after FoodScience workers discovered that there was an error on the label. The label indicated that the suggested use for children ages 3-5 was 1 chewable tablet, and children ages 6-12, 2-3 chewable tablets. However, the label should have read ages 4-16 take 1 chewable tablet daily.

Although no illness or adverse events have been reported to date in connection with this product, this product could pose a risk to children if taken for an extended period of time.

This product is packaged in white bottles with a white child resistant bottle cap. The lot number is stamped vertically to the right side of the supplemental fact panel on each label. The following is a list of the products and the lot numbers:

DaVinci Laboratories of Vermont Kid's Mighty Vites (90 tablet bottle) Lot #s 6741500 0311 and 6741600 0311 and 6988100 0311FoodScience of Vermont Kids Superior (90 tablet bottle) Lot #s 6741500 0311 and 6741600 0311and 6988100 0311 and 7198100 0311Mountain Naturals of Vermont Kid's Superior (90 tablet bottle) Lot #s 6741700 0311Sherlock Vitamins Smart Strong Focus (60 tablet bottle): Lot # 6747900 0311 Elders International, Inc. M10-8® Kids IQ Secret (90 tablet bottle): Lot # 6830700 0311Guyer Institute HEALTHY KIDS MV (90 tablet bottle): Lot # 6784400 0311

Consumers who have purchased the product and lot number in the above listing are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-451-5190 and ask for Recall Assistance.

For additional recall information see: http://www.fda.gov/Safety/Recalls/ucm166346.htm

Labels: Children Vitamins, FDA, Kids Multivitamin

The Food and Drug Administration said Friday, June 12, 2009, Krystexxa may successfully treat gout, despite evidence of potentially deadly side effects.

Krystexxa is manufactured by Savient Pharmaceuticals of New Jersey.

Krsytexxa’s new drug application has been under review since December. The FDA already has delayed a decision on the drug once.

Krystexxa is an injectable enzyme designed to lower the body's uric acid levels when administered either once or twice a month. Gout is a condition caused by a buildup of uric acid in the body. The drug appears to reduce gout’s symptoms such as relieving swollen joints and pain flare up. Gout affects about 8 million Americans and is most common in men over 40.

In a clinical study, about 24 percent of patients taking Krystexxa suffered a serious side effect, compared with 12 percent of patients taking a placebo pill. There were six deaths among patients taking the drug compared with three among patients taking placebo, though FDA noted many of them had pre-existing heart conditions.

"Because most of the patients developing the serious cardiovascular adverse events had other cardiovascular risk factors... there was uncertainty concerning whether the cardiovascular adverse events represent a genuine safety signal," states Dr. Bob Rappaport, FDA's director for rheumatology products, in a review posted to the agency's Web site.

The FDA is scheduled to ask a panel of outside arthritis experts next Tuesday to weigh in on the drugs risks and benefits. Though not required not required to follow the group's advice, the FDA generally adopts their recommendations. A final decision on Savient's drug is expected by the end of July.

It is possible that the FDA will consider whether additional studies are needed to evaluate Krystexxa's impact on the heart.

An analyst said the drug can likely win approval so long as the company agrees to limit its use to the target patient population and closely monitor negative side effects. The company is specifically seeking an indication for gout patients who are not receiving relief from other treatments.

For more information: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm155149.htm

Labels: death, drug application, enzyme, FDA, Gout, Krystexxa, savient, uric acid

On Friday, the FDA provided a follow up report from their March 2008 and January 2009 safety reports regarding a certain class of asthma drugs known as leukotriene modifiers. The FDA is now recommending a label change, wherein manufacturers should include in their label a warning concerning neuropsychiatric events that have been reported. The drugs that are affected by this recommendation are: montelukast (brand name Singulair), zafirlukast (brand name Accolate), and zileuton (brand name Zyflo and Zyflo CR). The neuropsychiatric events that have been reported are mostly behavioral, such as mood changes, anxiousness, dream abnormalities, and hallucinations.

Leukotriene modifiers are drugs that mainly are used to treat asthma, but some are also used for allergies. Leukotriene is a chemical released by the body in response to an inflammatory stimulus such as when an allergen is inhaled by a person. Montelukast and zafirlukast block the receptor sites for leukotriene. Zileuton is a leukotrine inhibitor, which blocks the production of leuktotriene all together.

For more information on the FDA report, see the FDA press release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166293.htm

See the Post-market Drug Safety Information:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm

See the MedWatch information:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166246.htm

Labels: Accolate, Asthma, FDA, leukotriene, neuropsychiatric, Singulair, Zyflo