Starting this summer, the heartburn drug Propulsid will not be found on pharmacy shelves. Its maker, Jannsen Pharmaceuticals, has opted to pull it because of recurring problems with abnormal heartbeats.
Between 1993 and 1999, 80 deaths have been linked to the drug along with more than 300 bad side effects. It's used to treat one of the world's most common ailments--heartburn. It was hailed as a unique drug that worked wonders for a small group of people like Bernard Schwartz.
"When I first started to take it I was in severe pain. I had real trouble I had very bad reflux and I couldn't control it," says Schwartz.
Propulsid received unanimous approval from the FDA in 1993. But over the years the list of people at risk grew longer than the risk of people who benefited from it. The drug maker has changed the label five times in an effort to get the drug correctly prescribed.
It should never be taken by anyone with heart problems, and it can have bad interactions with as many as 40 drugs. Some say that's too many for doctors to keep up with.
Consumer watchdog Sydney Wolfe of Public Citizen says it's a perfect example of a drug that should never have been given FDA approval and should be withdrawn immediately.
But 10 Million people have taken Propulsid--the majority with no trouble.
"I think the FDA was correct in approving the medication. It does fill a very important void," says Dr. Lawrence Cohen of Mount Sinai Hospital in New York.
Propulsid will remain on the market for five months. After that, people who rely on it like Bernard Schwartz will have to apply for it. The drug company is considering giving it to them for free.
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