On Apr. 27, 2012, the FDA sent warning notices to 10 drug companies manufacturing and distributing dietary supplements that contain dimethylamylamine, also known as DMAA. The FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.
Under law, manufacturers of dietary ingredients are responsible for notifying the FDA within 75 days of marketing their products with evidence that supplements containing new dietary ingredients are safe. "Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They havenâ€™t done that..." said Daniel Fabricant, PhD, Director of the FDAâ€™s Dietary Supplement Program, in an FDA press release.The FDA warned the pharmaceutical companies that because synthetically-produced DMAA is not a dietary ingredient, it is â€śnot eligible to be used as an active ingredient in dietary supplements.â€ť
According to the FDA, DMAA â€śis known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.â€ť Forty-two adverse event reports regarding products containing DMAA have been reported.
Last Updated (Wednesday, 02 May 2012 18:40)
Written by Drug Recall Writer
Anybody who watches television, surfs the Internet or flips through a magazine is very familiar with advertising for pharmaceutical drugs picturing attractive, healthy and active people. Prescription and over the counter drugs are used by millions of consumers for various ailments, diseases and medical conditions. For most, prescription drugs can provide great benefit or relief. A consequence of the development of many drugs and the marketing to millions of consumers, are serious side effects or other undesired results. In extreme cases, the U.S. Food & Drug Administration (FDA) or manufacturer may recall or withdraw a drug.
Over the past few years, the safety of more than a dozen popular prescription drugs has been examined. In some cases, certain drugs have been recalled following reports of serious injury or death.
The recent recall of numerous popular drugs has resulted in heightened scrutiny of certain blockbuster drugs with hearings before Congress in which at least one FDA researcher suggests that the FDA may be incapable of protecting consumers from unsafe drugs and that several other popular drugs currently on the market may also present unacceptable patient risk. According to a survey by the Department of Health & Human Services Office of Inspector General, about two-thirds of Food & Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.
DrugRecalls.com is a consumer resource from product liability lawyers engaged in assisting consumers suffering side effects from pharmaceutical drugs.
Not all drugs referenced on this website have been subject to recall or warning. Patients should never stop taking their medicine without first consulting with their physician.
Written by Drug Recall Lawyer
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Drug Recall lawyer Dana Taschner is one of the most respected trial lawyers in the United States. Dana has represented numerous individuals in pharmaceutical cases throughout the United States and founded Drug Recalls to provide helpful news and legal information about significant drug recalls impacting millions of consumers. Dana has provided expert legal analysis on CNN and MSNBC, and has been involved in some of the most significant and challenging legal cases in the United States over the last three decades: See Wall Street Journal article quoting Dana on nationwide consumer lawsuits on July 8, 2011 http://online.wsj.com/article/
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Dana has been involved in many of the most significant and serious Food and Drug Administration (FDA) or manufacturer drug recalls in history, including: Silicone Gel Breast Implants (FDA ban in 1992), Norplant (birth control implant recall), Fen-Phen (diet drugs recalled in September 1997), Rezulin (diabetes drug recalled in March 2000), Sulzer (hip device recalled in 2000), Baycol (cholesterol drug recalled in August 2001), Zyprexa (schizophrenia drug warning of 2004), Ortho Evra (birth control patch recalled in 2004) Avandia (diabetes drug recalled in July 2007), Paxil (SSRI Black Box Warning 2004), and Depuy Recall (hip device recalled in August 2010). Dana represented thousands of consumers adversely affected by these products after serious side effects or deaths were reported in connection to these pharmaceuticals. Dana has filed the first legal claim in the Courts of the United States following FDA or manufacturer recall in certain national recall cases.
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For twenty consecutive years Dana has been awarded the highest national AV-rating (preeminent) for his legal ability and ethics based on reviews by judges and lawyers. Dana was awarded the American Bar Association's Sole Practitioner of the Year from a field of 400,000 lawyers, and the United States Senate honored Dana with a Senate Tribute, stating, "Taschner has achieved national recognitionâ€¦ Taschner truly brings honor to his profession." The Senate Majority Leader read into the Congressional Record, "Mr. Taschner's devotion to fighting oppression earned him the American Bar Association's Lawyer of the Year award."