Uprima - Side Effects

Reported by observers
at the advisory panel hearing (April 10, 2000) ---
The FDA advisory committee apparently took a very cautious stance with respect to the safety of Uprima in view of the side effects of a rival product. The committee has that (1) package inserts supplied with the drug include a warning that great care be taken in the product's use and (2) educational materials about the drug be distributed to patients. The advisory committee's main concerns are apparently threefold: (1) evidence of interaction when taken with alcohol, (2) evidence of interaction with nitrate compounds, and (3) side effects of nausea in about 32% of all patients (and 16% of patients on low doses) and, in rare cases, of syncope.

Consumer Advocacy Group Raises Safety Concerns