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 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

FDA takes Steps to Fight Counterfeit Drugs

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

The FDA recently sent General Mills a Warning Letter informing General Mills that certain statements made in the advertisements for Cheerios violate the Food and Drug Act. The FDA determined that these claims were improper because the claims would cause Cheerios to be classified as a drug, rather than a food. This would violate the Food and Drug Act because General Mills has not taken the proper steps to have Cheerios approved as a drug.

The claims made by General Mills that would cause Cheerios to be categorized as a drug, rather than a food, are:

• "you can Lower Your Cholesterol 4% in 6 weeks"
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

The problem with these statements, according to the FDA, is that they are not adequately supported by scientific studies. However, this appears more to be an issue of semantics than safety, as the FDA recognizes that soluble fiber from whole grain oats (the main ingredient in Cheerios) is associated with lowering cholesterol and reducing the risk of heart disease. General Mills does state on the front of the Cheerios box that the whole grain oats found in Cheerios contain soluble fiber, which can lower cholesterol and the risk of heart disease. However, the above claims about lowering cholesterol appear on the back of the Cheerios box. The FDA suggests that the claims regarding cholesterol on the back of the box would have been proper if General Mills had put them on the same side of the box as the claim about soluble fiber.

Adverse events associated with pharmaceutical drugs and devices are suffered and reported on a daily basis. Many of these drugs and devices cause serious, life-threatening injuries. In the case of Cheerios, however, the FDA recognizes that there are no safety concerns associated with Cheerios, and in fact, consumption of whole grain foods such as Cheerios is encouraged. The public would be better served if the FDA focused their efforts toward policing these dangerous drugs and devices, rather than picking on Cheerios, which the FDA admits is safe and encourages people to consume as part of a healthy diet.

Labels: Cheerios, cholesterol, coronary, drugs, FDA, fiber, food, heart disease, oats, soluble fiber, whole grain

The Food and Drug Administration (FDA) has released several alerts over the last six months about the illegal and possible dangerous addition of active prescription drug ingredients to otherwise ineffective weight-loss supplements. The FDA has identified 72 weight loss products that illegally contain at least one active prescription drug. The prescription drugs being added to these weight loss products include:

• Sibutramine (MERIDA) - A controlled substance and an appetite suppressant available by prescription only.
• Fenproporex- A stimulant drug that is not approved for marketing in the United States.
• Fluoxetine (PROZAC, SERAFEM) - An antidepressant available by prescription only
• Bumetanide (BUMEX) - A diuretic available by prescription only
• Furosemide (LASIX) - A potent diuretic available by prescription only.
• Rimonabant (ZIMULTI)- An appetite suppressant not approved for marketing in the United States.
• Cetillstat- An experimental obesity drug not approved for marketing in the United States.
• Phenytoin (DILANTIN) An anti-seizure drug available by prescription only.
• Phenolphthalein- A suspected cancer causing agent and a solution used in chemical experiments. This drug is not approved for marketing in the United States.

The FDA warned that these tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages.

If you have any products containing these ingredients, you should stop taking them immediately, and consult your health care providers. In addition, consumers should seek guidance from health care providers prior to purchasing any weight loss products.

Consumers and health care providers should report any side effects of weight loss products to the FDA’s MedWatch Adverse Event Reporting Program. This can be done at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

Labels: drugs, FDA, health care providers, weight loss pills

The Food and Drug Administration (FDA) decided to issue a public health advisory about the danger of liver damage from Hydroxycut use after compiling a total of 23 reports of liver injury associated with Hydroxycut use, including one death from liver failure. According to a letter to the editor published in the April 14, 2009 issue of the World Journal of Gastroenterology, current reports of liver damage from Hydroxycut may underestimate the actual numbers by "several orders of magnitude."

Did you take Hydroxycut? Are you concerned that you may have suffered liver damage as a result? Here are symptoms to look out for:

• Yellowing of the skin and/or whites of the eyes (jaundice)
• Brown or dark-colored urine
• Pale stool
• Nausea, vomiting, or loss of appetite
• Pain or sensitivity in the stomach or abdomen
• Excessive fatigue or shortness of breath
• Weakness or muscle pain
• Itching
• General feeling of being unwell

If you are currently taking Hydroxycut and are experiencing these symptoms, you may have suffered liver damage. If you experienced these symptoms in the past, but stopped using Hydroxycut and the symptoms cleared, you may have suffered liver damage. If you were diagnosed with hepatitis while or after using Hydroxycut, your liver damage may also have been associated with Hydroxycut.

If you believe you or a loved one may have suffered liver damage as a result of taking Hydroxycut, please schedule a Hydroxycut injury consultation with the product liability lawyers at Schlichter, Bogard & Denton today.

Labels: drugs, FDA, Hydroxycut, liver damage

On May 1, 2009, the Food and Drug Administration (FDA) issued two statements about Hydroxycut-branded dietary supplements. In a public advisory, the FDA urged consumers to immediately stop use of Hydroxycut. It talked about the risk of liver injury that had been correlated with Hydroxycut use.

On the same day, the FDA issued a letter to healthcare professionals, describing Hydroxycut products as a "serious public health risk." It talked about reports of 23 cases of liver damage associated with the use of Hydroxycut, some leading to full liver failure, and one to patient death. The letter asked doctors to report liver damage associated with Hydroxycut and review previous cases of hepatitis, characterized by liver injury, to see if they were associated with Hydroxycut use.

In preparing its statement, the FDA informed Iovate Health Sciences, Inc, the manufacturer of Hydroxycut, about its findings. How, exactly, a recall was decided on seems unclear. According to Iovate health Sciences, the company "initiated a voluntary recall when it became aware" of the FDA's findings. According to the FDA statement, "Iovate has agreed to recall" all 14 varieties of Hydroxycut named by the FDA. These varieties are:

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

Not all varieties of Hydroxycut have yet been found to be associated with liver damage, but in many cases, injury reports take a long time to reach the FDA. The Hydroxycut-associated death occurred in 2007, but did not reach the FDA until March 2009.

With doctors reviewing past cases of liver damage, it is likely that more cases will be linked to Hydroxycut use. If you suffered liver damage while using Hydroxycut, schedule a Hydroxycut injury lawsuit consultation with the pharmaceutical liability lawyers at Schlichter, Bogard & Denton today.

Labels: attorney, drugs, FDA, Hydroxycut, liver damage

Attorneys that represent plaintiffs in a lawsuit against the drug manufacturer AstraZeneca, maker of the anti-psychotic Seroquel, planned yesterday to release documents that show that executives in the company discussed promoting the off-label use of Seroquel in children and elderly patients. While there is no evidence that AstraZeneca actually promoted the off-label use of Seroquel, the plaintiffs’ attorneys charge that internal documents show that executives had plans to “broaden Seroquel use on and off label” including among patients with Parkinson’s and Alzheimer’s disease. The same documents also show that executives said that there was a need for “aggressive market penetration” among adolescents, the elderly, and patients with bipolar disorder and other groups in order for Seroquel to grow faster than rivals.

Seroquel was introduced in 1997 to treat psychotic disorders, schizophrenia, and bipolar disorder. Many doctors liked to prescribe Seroquel over other antipsychotics because it has a decreased risk of side effects related to loss of motor control, which many other antipsychotics carry. Seroquel does have its own safety risks, however. The drug has long been linked to weight gain and diabetes, and in 2005 the FDA issued a warning that Seroquel, among other drugs, was linked to death in the elderly. Currently AstraZeneca, the manufacturer of Seroquel, faces over 9,000 lawsuits filed by people who claim that the company withheld information about the antipsychotics’ diabetes risk. AstraZeneca deny that the documents held by the attorneys indicate a desire by AstraZeneca officials to promote off-label uses.

For more information, visit the Wall Street Journal’s online article:
http://online.wsj.com/article/SB123570604586190627.html
For the FDA’s warning, visit: http://www.fda.gov/cder/drug/InfoSheets/HCP/quetiapineHCP.htm

Labels: antipsychotic, drugs, FDA, quetiapine, Seroquel, warning

The Justice Department and sixteen states have joined in lawsuits alleging that drug giant Wyeth, defrauded the federal government out of millions of dollars. Wyeth has not been a stranger to lawsuits. Just this past November, Wyeth was at the center of a lawsuit regarding a woman’s horrific experience with the drug Phenergan. Diana Levine went to a local health care provider seeking treatment for a migraine. A physician administered Phenergan intravenously. But because the drug was improperly administered, Levine’s arm because gangrenous and ultimately had to be amputated. Levine filed suit against Wyeth arguing that the warning label did not adequately advise or address risks associated with the use of Phenergan.
However, now Wyeth has another big problem to deal with. The lawsuits filed in federal District Court in Massachusetts claim that Wyeth avoided paying hundreds of millions of dollars in rebates to state Medicaid programs for its Protonix Oral and Protonix IV acid- reflux drugs. The compliant alleges that from 2000-2008 Wyeth sold the two medicines to thousands of hospitals at a large discount in a bundled package called the Protonix Performance Agreement.
“By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have”, stated Tony West, assistant Attorney General for the Civil Division, in a news release. Wall Street Journal
Wyeth will likely settle this case before being acquired by Pfizer Inc. later this year.

Labels: drugs, federal, government, lawsuit, Medicaid, migraine, wall street