FDA Issues Draft Guidelines For Monitoring Drug Side Effects, Risks After Approval
New FDA proposed guidance gives new direction to staff on how to handle postmarketing surveillance of drugs and biologics.
Tag Archives: Drug Side Effect
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Many in U.S. Lack Education on Drug Side Effects, Benefits: Study
Americans may expect more out of new drugs than they are likely to get, according to the findings of recent research.
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Actos Side Effects May Raise Bladder Cancer Risk: Study
Further evidence seems to suggest a possible link between side effects of Actos, a popular diabetes drug, and a potential increased risk of bladder cancer.
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Prilosec, Nexium, Other PPIs Can Cause Low Magnesium Levels: FDA
Prescription strength Prilosec, Nexium and similar stomach acid reducing drugs, known as proton pump inhibitors (PPIs), will have to carry new label warnings alerting consumers to a risk of low…
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Generic Drug Maker May Be Held Liable for Failure to Warn: Appeals Court
A federal appeals court has rejected an argument by a generic drug manufacturer that it should be immune from liability through product liability lawsuits simply because they are copying the…
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Dilantin Toxic Epidermal Necrolysis Lawsuit Results in $3.78M Settlement
Pfizer Inc. has reached a $3.78 million settlement in a wrongful death lawsuit brought by the family of a 9-year-old New York girl who died from toxic epidermal necrolysis (TEN),…
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Provigil Side Effects Linked to Risk of Addiction
New research suggests that side effects of Provigil, the popular narcolepsy drug which is widely used off-label to provide a mental boost, may cause some people to become addicted to…
