A newly-launched website by the U.S. Food and Drug Administration (FDA) makes it easier for consumers and doctors to find drug safety information about recently-approved medicines. The web page, titled the Postmarketing Drug Safety Evaluations site, will set forth information the FDA collects about new drugs, either18 months after the drug’s approval by the agency [...]
A new, still-unpublished study warns of a greatly increased risk of heart attacks, strokes, and other problems in patients taking the diabetes drug Avandia. The study, by FDA scientist David Graham, reported as many as 48,000 adverse events between 1999 and 2009 in patients using drug, which is manufactured by GlaxoSmithKline Plc. The study reported [...]
The U.S. House Oversight and Government Reform Committee is investigating whether Wyeth illegally marketed the drug Rapamune for unapproved uses. Rapamune is approved by the FDA to prevent organ rejection following kidney transplants. However, the committee is probing whether the drug company aggressively marketed the drug to prevent other organ rejection, uses not approved by [...]
The U.S. Food and Drug Administration (FDA) has ordered five companies selling genetic test kits to prove their validity. The kits test consumers’ DNA for genetic predispositions to diseases like diabetes, macular degeneration, and breast cancer, as well as the body’s response to certain types of medications. The FDA, stating that the tests are medical [...]