Trumm Drug

June 2009 Drug News

FDA approves OTC Prevacid

Novartis announced it received FDA approval to sell an OTC version of Prevacid 24HR (lansoprazole 15mg delayed release capsules). The prescription version was one of the top five prescription brands in the U.S., with annual sales of $3.37 billion in 2008, according to an analyst at Helvea in Zurich. Sales of the OTC version are expected to be much lower, with estimates between $150 million to $200 million. Prevacid 24HR is the first proton pump inhibitor approved as an OTC since 2003 and is expected to be available in 2009. (PR Newswire 5/14/09, Wall Street Journal 5/15/09)

Appeals court allows sales of Teva’s generic of Protonix

The U.S. Court of Appeals for the Federal Circuit upheld a lower-court ruling that allows Teva Pharmaceuticals to sell its generic version of Wyeth/Altana’s Protonix (pantoprazole). A Wyeth spokesman stated the company continues to believe in the strength of its patent for Protonix despite the decision. Teva is currently in patent litigation with Wyeth and Altana and a trial date has not been set. (Bloomberg 5/14/09, Teva Press Release 5/14/09)

Pfizer starts free drug program for newly unemployed

Pfizer is offering up to one year of free medication, such as the Lipitor and Viagra, to Americans who lost employment and health insurance. The program covers more than 70 drugs for people who can demonstrate unemployment since January 1, have no drug insurance and were taking a Pfizer product for at least three months prior to the job loss. People who are interested in enrolling in the program should go to http://www.PfizerHelpfulAnswers.com. (Bloomberg 5/14/09)

Medicare Interactive Counselor Helps Navigate Insurance Maze

Medicare Interactive (MI) Counselor is an independent, online resource that helps the nearly 45 million people with Medicare navigate the complex world of health insurance. The only comprehensive, consumer-friendly source for Medicare information on the web, MI Counselor provides easy-to-understand answers to the questions posed by older people and people with disabilities, and the advocates and caregivers that navigate the system on their behalf. A service of the nonprofit Medicare Rights Center, MI Counselor draws on the experience and best practices of expert case workers, lawyers, education professionals and health literacy specialists. For more information, please go to http://www.medicareinteractive.org/.

FDA Warns Consumers to Stop Using Hydroxycut Products
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. “The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
-Online: http://www.fda.gov/MedWatch/report.htm
-Regular Mail: Use FDA postage paid form 3500 found at: http://www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-Fax: 800-FDA-0178
-Phone: 800-FDA-1088
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.