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potential side effects 3 articles

FDA considers toning down side effects disclaimers on prescription drug ads

The Food and Drug Administration (FDA) is considering overhauling regulations for television and radio advertisements for prescription drugs, possibly reducing the long list of potential side effects in an effort not to tune out or scare off consumers. Drug manufacturers are required to disclose major adverse reactions to the drugs they are promoting in their advertisements. In some cases, the rundown of side effects consumes a large portion of the ad itself, which the FDA worries may leave viewers a bit glassy eyed and oblivious to the message. Those potential side effects can also sound alarming – in some cases ... Read More

FDA proposes new rule to allow generic drug makers ability to update safety labels

The Food and Drug Administration (FDA) is taking steps to allow manufacturers of generic drugs permission to change safety labels when new information about potential side effects is discovered. Currently, generic drug makers are required to have the same safety labels as their brand-name counterpart. For years, citizen groups have petitioned the FDA to take measures to ease the regulations that prevent generic drug companies from providing new information about potential risks associated with their products. Brand-name drugs go through a rigorous approval process through the FDA during which they must provide data from clinical trials demonstrating the drug’s safety ... Read More

Alabama court rules that makers of brand name drugs can be sued by generic drug users

Generic drugs should carry the same warnings as the brand name drug and, if not, then users of the generic drug can sue the name-brand drug maker for fraudulent misrepresentation, the Alabama Supreme Court ruled. The ruling comes as a response to a certified question from a U.S. District Court, which arose during a case where a plaintiff alleged that a generic version of the prescription heartburn drug Reglan caused him to develop a movement disorder called Tardive Dyskinesia. The plaintiff sued the brand name maker, Wyeth, alleging that the company failed to warn both doctors and patients of the ... Read More