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

A new study published today in the journal Pediatrics, links a chemical used in many plastic products to an increased risk of liver problems in premature babies. The study was conducted at a hospital in Germany. The study suggests that a chemical known as phthalate, which is used in some plastic intravenous feeding bags and tubing, may raise the chance of liver damage in babies that are born prematurely.

Premature babies have livers that are immature so they are already at risk for liver complications. Further, many times they are fed intravenously, a practice which is also known to increase liver problems. The study suggests that one possible reason for the increased liver problems with intravenous feeding is the chemical phthalate which is used in the tubing.

The study tracked 30 premature infants that were treated in the intensive care unit before the hospital switched to feeding equipment without the chemical, and 46 infants treated there afterward. Serious liver problems developed in 50% of infants fed with tubes containing phthalate versus only 13% of the other infants.

Some experts say the study is unconvincing, but others, such as Deborah Cory-Slechta, an environmental medicine professor at the University of Rochester medical school said, “This is a pretty strong damnation of” phthalates. “It needs to be replicated. But I still think this makes a very strong case for getting rid of these compounds” in infant intensive care units.

In a 2002 phthalates advisory, the FDA recommended alternatives for patients most at risk from the chemical leeching out of plastic medical equipment, including sick infant boys because of possible damage to developing reproductive organs. Some hospitals in the United States have already switched their feeding bags and tubing to items that do not contain phthalates. Further, some countries and California have restricted the use of phthalates. Phthalates can also be found in many other items besides medical supplies, such as toys, vinyl flooring and cosmetics. Phthalates are different from bisphenol-A, or BPA, a plastic-hardening chemical that also has raised health concerns and is found in food containers and other products. It's no longer used in many baby bottles.

For more information, see the article from MSNBC at:
http://www.msnbc.msn.com/id/32157844/ns/health-kids_and_parenting/

Labels: baby bottles, BPA, infant, liver damage, Pediatrics, Phthalate, premature

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

The manufacturer of Hydroxycut, the brand name associated with several dietary supplements used to help with weight loss, issued a voluntary recall after the FDA issued an advisory on May 1, 2009. The advisory stated the liver damage being caused appears to be relatively rare, but the FDA wanted to warn consumers of unnecessary risks associated with the supplement. The voluntary recall includes 14 Hydroxycut products including Hydroxycut Regular Rapid Release Caplets, Hydroxycut Caffeine-Free Rapid Release Caplets, Hydroxycut Regular Drink Packets, Hydroxycut Liquid Shots, Hydroxycut 24, and Hydroxycut Natural, and others.

Prior to the FDA advisory, the agency received 23 reports of liver-related problems and at least one reported death associated with Hydroxycut products. According to the FDA, at least nine million packages of Hydroxycut products were sold last year. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these products, which contain a variety of ingredients, including herbal extracts.

Side effects associated with Hydroxycut products include jaundice, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. More severe adverse reactions have included severe liver damage.

For more information about the FDA warning, see http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

For more information about the Hydroxycut recall, see http://www.fda.gov/oc/po/firmrecalls/iovate205_09.html

Labels: jaundice, liver damage, recall