A Food and Drug Administration advisory panel this week recommended approval of a new drug, Uprima, for male impotence. The drug, however, can have some serious side effects. Uprima takes a neurological approach to treating erectile dysfunction (ED); it works by raising levels of the neurochemical dopamine in a part of the brain that is believed to be important for male erections, and for this reason, it might not be effective for all forms of ED. The drug is supposed to be taken about half an hour before sex. It is placed under the tongue and allowed to dissolve into the mouth tissue. In month-long studies of 3,000 men, a 4-mg dose was effective 56 percent of the time, according to TAP Pharmaceuticals, manufacturers of prima. The 4-mg dose caused seriously low blood pressure and even fainting in one of every 30 men who took it. Five percent of the men also experienced nausea, vomiting, dizziness, sweating or sleepiness, and in some cases these side effects led to injuries from falling or, in one case, a car wreck involving a man who was driving when he became dizzy from the drug. The FDA panel is concerned because of the potential for cardiac patients and people with low blood pressure to be prescribed the medication.
SOURCE/REFERENCE: Reported by www.intellihealth.com 4/15/00
