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January 2020
In this month’s news brief, we highlight a recent letter that the FDA issued to drugmaker Vivus that cited the company for making false or misleading claims on a promotional consumer-directed webpage for its oral weight-loss prescription drug QSYMIA, which we have designated as Do Not Use.
September 2003
Canadian drug regulatory authorities reviewed reported cases of serotonin syndrome in the July 2003 issue of the Canadian Adverse Reaction Newsletter. The serotonin syndrome is a potentially life-threatening adverse drug reaction involving an excess of serotonin, a naturally occurring nerve transmitter.
April 2003
On February 24, 2003, Eli Lilly and Company of Indianapolis informed healthcare professionals that the professional product labeling, or “package insert,” for pergolide (PERMAX) was being updated to include a warning about the possibility of heart valve damage with the drug.