Inconsistency seen in safety labeling for generic drugs

An article published in  Pharmacoepidemiology and Drug Safety notes that over two-thirds of generic drugs in the U.S. have safety warning labels that differ from the equivalent brand-name medications.

According to the lead author, Jon Duke, "generic drug labels may contain incomplete or incorrect safety information."  This becomes problematic when the generic label is used by the physician to make prescribing decisions. If side effects, information on durg interactions or other safety issues are not in the label, then the patient may be at an increased risk for adverse events.

Out of more than 1,000 generic drugs, nearly 70% had some discrepancies in their safety labeling. Strikingly,  9% had differences of more than 10 side effects.

Antinausea Drug Withdrawn From US Market

The FDA announced that the 32 mg dose of Zofran (ondansetron), an anti-nausea medication, will no longer be marketed in the US due to the potential the risk of Torsades de pointes, a serious cardiac rhythm abnormality.  The event occurs when there is a prolongation in the QTc interval, an important part of the electrical activity of the heart.  Prolongation of the QTc can be fatal.  Information from the FDA can be found here.