A popular new high blood pressure drug -- Selacryn (chemically, ticrynafen) -- was suspended yesterday because of reports of liver damage and deaths after its use.
The Food and Drug Administration and Smith Kline & French, the drug's maker, agreed on the action after a day-long emergency meeting at FDA headquarters.
Smith Kline & French will immediately notify doctors and druggists of the suspension and recall, pending more study. But patients taking Selacryn were told by the FDA to "promptly contact their doctors, rather than stopping the drug on their own."
Some 300,000 people have taken the drug since the FDA approved it in May.
Several other drugs can be used to control high blood pressure and its effects, and it is important for many patients to stay under treatment. Nationwide study has shown that controlling even borderline high blood pressure can sharply decrease the risk of death.
Up to yesterday, either the FDA or the manufacturer had received 52 reports of adverse reactions to Selacryn. The 52 cases included five suspicious deaths. But it is not possible to say, according to the FDA, whether the drug, a virus disease, alcoholism or some other cause was responsible.
The incidence of liver damage was too low to have been detected in premarketing tests, FDA reported.Dr. Richard Crout, head of FDA's bureau of drugs, said "A good reporting system, properly utilized by physicians, Smith Kline & French and the FDA, has worked the way it was designed . . . to protect public health."
Doctors prescribed the drug in large part for elevated uric acid levels caused by high blood pressure or by water retention associated with high blood pressure -- as well as for water retention associated with congestive heart failure.
FDA said that after more study the drug either will be returned to the market -- almost certainly with new cautions -- or be withdrawn permanently.