DRUGS/DEVICES Legal News Articles & Interviews

Washington, D.C. The American Association of Justice’s (AAJ) review of 150 years of drugs and devices offered to ostensibly improve or protect the health of women, sometimes with devastating even deadly results, is a well-researched, informative and sometimes oddly entertaining read.

Vancouver, BC While drug companies do not have the moral, ethical or legal authority to promote drugs off-label for uses for which they are not indicated, doctors can, and do. That’s because a doctor’s knowledge and training allows the physician to assess the needs of a patient against the monographic and other formulaic information associated with a specific drug, and prescribe the medication for an indication not sanctioned by the US Food and Drug Administration (FDA) or Health Canada.

Washington, DC McNeil Consumer Healthcare Division of McNeil PPC Inc. (McNeil) has announced a recall of certain lots of Motrin IB 24 count coated caplets, Motrin IB 24 count coated tablets and Motrin IB 24+6 count coated caplets from retailers. The recall involves 12 million bottles of the pain reliever.

Washington, DC According to results from a new study released by the Food and Drug Administration (FDA), newer generation birth control pills such as YAZ/Yasmin increase the risk of blood clots more than older generation pills.

Vancouver, BC For the first time anywhere, a Canadian study has revealed a potential for Creutzfeldt-Jakob disease (CJD) associated with the use of fertility drugs. A close cousin of CJD is bovine spongiform encephalopathy (BSE), more commonly known as "mad cow disease." Study authors stress that so far the danger is theoretical—and if there were a risk at all, the risk would likely be minor at best. There have been no reported cases.

London, UK GlaxoSmithKline (GSK), the maker of the infamous diabetes medication, Avandia (rosiglitazone maleate), has announced that it will set aside $3.4 billion to pay for investigations by the US government and product liability lawsuits stemming from its marketing of the drug. The amount is expected to wipe-out GSK's quarterly profit which will be reported on February 3.

Washington, DC The US Food and Drug Administration (FDA) is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.

Washington, DC An FDA advisory committee has voted 13-7 in favor of approving a new diet drug designed to aid weight loss.

Washington, DC An advisory committee of the Food and Drug Administration has recommended that intravenous (IV) phenytoin, an anti seizure medication marketed as Dilantin, should be labeled with warnings that the drug can cause Purple Glove Syndrome, (PGS). The panel stopped short of having the drug pulled from the market.