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Popular Heartburn Drug Continues to Cause Deaths

Consumer Group Turns Up the Heat on the FDA

Apr 13, 2000 | WebMD The FDA is endangering people's lives by failing to insist on the immediate withdrawal of the heartburn drug Propulsid, a citizen advocacy group is charging.

The group, Public Citizen, says it has uncovered 23 deaths involving Propulsid that occurred right before or immediately after the FDA's March announcement that the drug will be withdrawn by mid-July. These deaths demonstrate the inherent danger of permitting the ongoing sale of that drug until the July deadline, the group says.

In a letter to FDA Commissioner Jane Henney, MD, Public Citizen director Sidney Wolfe, MD, writes that these new reports of deaths due to heart rhythm abnormalities emphasize the serious public health dangers of the FDA's going along with the drug companies' reckless decision to allow this deadly drug to remain in drugstores until July.

Propulsid, approved in 1993 for the treatment of severe nighttime heartburn, is known to cause life-threatening heart rhythm abnormalities even in people with no heart disease. In fact, the decision to withdraw Propulsid was a result of its link to 341 reports of heart rhythm abnormalities, including 80 deaths, as of December 1999.

These latest deaths, reported between Jan. 1 and March 28, involve patients ranging from a 9-month-old male infant to a 77-year-old man.

But although the drug will be withdrawn, doctors will still be able to prescribe the drug through a limited access program for patients for whom no other treatment option exists, the FDA said at that time. The withdrawal date will be delayed until July 13 to provide adequate time for patients and physicians not participating in that program to find another treatment, the FDA said.

The July deadline becomes especially disturbing when taken in light of the plan to make the drug available under the limited access program, says Larry Sasich, PharmD, MPH, spokesman for Public Citizen. The group supports the development of a limited access program to allow patients with no other treatment options to continue on Propulsid, he says. However, Public Citizen's main concern is that the FDA literally has given the company too much time to develop this program, he says.

"The FDA has never done this before. It is unprecedented," Sasich tells WebMD, while noting that similar programs have been set up in less than a day.

But the delay in Propulsid's withdrawal primarily is a result of that program, Florence Houn, MD, MPH, director of the FDA office responsible for Propulsid, tells WebMD. The company is setting up three separate programs for infants, children, and adults with guidelines that are reasonably complicated, she says.

In addition, there are patients using the drug that might need additional time to find an alternative treatment option, Houn says. The limited access program also requires that certain lab tests be done prior to enrollment in the program, which could easily tack on some additional time for certain patients, she adds.

As for the recent deaths, the FDA is reviewing those reports, Houn says. The problem is that each report must be evaluated individually for accuracy and reliability, she tells WebMD.

In the meantime, a "Dear Doctor" letter has been sent out to encourage physicians to look for new treatment options, says Greg Panico, a spokesperson for Janssen Pharmaceutica, the manufacturer of Propulsid. And while the drug is still being shipped to pharmacies, it is because the company presently has no other way to provide the drug to patients that need Propulsid, he says.

"I'm already getting calls from patients who fear that they will be in serious trouble if they can't get access to Propulsid," he tells WebMD.

But these excuses and rationales are unlikely to satisfy Public Citizen. Sasich says that patients are not being screened carefully enough by doctors to see if they are at risk of having a heart rhythm problem with Propulsid, such as people with heart disease or abnormal tests. "We can guess that there are also some people with risk factors that either their doctor or they themselves are not aware of," he tells WebMD.

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