New Bowel Drug Ordered Off Shelves

Just as it should have, the FDA withdrew a drug which had killed between 3 and 5 people.  Thousands of children may have died from vaccinations.  What's the deal? - SM

November 29, 2000 - New York Times

New Bowel Drug Ordered Off Shelves
By MELODY PETERSEN

The Food and Drug Administration yesterday asked the maker of Lotronex, a
treatment for irritable bowel syndrome, to take the drug off pharmacy shelves after dozens of patients suffered serious side effects and at least three died.

The manufacturer, Glaxo Wellcome, a British drug company, said it would
immediately comply.

The drug, which had been recommended for use by women with chronic diarrhea, had been on the market for fewer than 10 months. At least seven prescription drugs have been taken off the market because of safety problems since September 1997 when Redux, a diet drug, was recalled.

Officials yesterday said five patients taking Lotronex had died, but they explained that a review of those cases showed that the drug may have contributed to only three of those deaths. About 70 other patients have suffered from severe constipation or ischemic colitis, a lack of blood flow to the colon, which can cause tissue to die, the officials said.

"We have become increasingly concerned," said Dr. Victor Raczkowski, deputy director of the Food and Drug Administration's office of drug evaluation.

Executives at Glaxo Wellcome said, however, that they were shocked that regulators had ordered the company to stop selling Lotronex. They said they continued to believe that the benefits of the drug outweighed its risks.

"We view it as a sad day for women with irritable bowel syndrome," said Dr. Richard S. Kent, the company's chief medical officer.

Irritable bowel syndrome is a condition that can cause abdominal pain and irregular bowel movements, including diarrhea and constipation. The officials said the problem could affect up to 15 percent of Americans.  Lotronex was the first drug approved to help those with the condition, and the agency speeded its review because of its possible benefits.

But reports of problems with the drug, which has been tried by 300,000 women in the United States, were received soon after it was approved. And, for months, Public Citizen, a consumer group in Washington, had been calling for a recall. The group said that the drug was too dangerous, considering that irritable bowel syndrome was not a life-threatening condition and that Lotronex had been shown to help only some patients.

Lotronex is the third prescription drug recalled by the Food and Drug Administration this year. In March, Johnson & Johnson took Propulsid, a medication for severe heartburn, off pharmacy shelves at the request of drug regulators. That same month, regulators took Rezulin, a diabetes drug made by Pfizer, off the market.

The withdrawals have renewed questions about whether the regulators' efforts to speed up drug approvals is allowing unsafe medicines to reach patients. The Food and Drug Administration has been approving drugs more quickly to satisfy complaints by the drug industry and Congressional Republicans, who asserted that it was taking too long to get new drugs on the market.

Larry Sasich, a pharmacist at Public Citizen, said yesterday that it was unclear whether Lotronex or the other drugs that have been recalled should ever have been approved.

"In each of these cases," Mr. Sasich said, "there were questions of the drug's safety even before it was approved."

Dr. Raczkowski said yesterday that the Food and Drug Administration had been aware that some patients taking Lotronex in clinical trials had suffered from ischemic colitis. He said that the agency delayed its approval of the drug by a month to review those cases and had found that complications were not serious.

Only in the last few months, after the drug was being widely prescribed, have more serious complications become known, Dr. Raczkowski said. He said that even though the approval of Lotronex had been put on a fast track, regulators had given it a thorough review. The agency had only given its review a priority over that of other drugs, he said.

The agency has reviewed its drug recalls since 1979 and has not found a disproportionate number in recent years, he said.

"Over time," Dr. Raczkowksi said, "the percentage of drugs being withdrawn has remained fairly constant."

Dr. Kent at Glaxo said the company had been closely working with regulators in recent weeks as questions of Lotronex's safety were raised. He said it was not yet clear that the deaths had been caused by the drug.

The company told the drug agency that it would be willing to change the drug's label and restrict its distribution to certain patients, Dr. Kent said. It also proposed that an independent panel review the drug.

But yesterday, officials told Glaxo that the drug caused such serious side effects that it needed to be pulled.

Patients can call Glaxo at (888) 825-5249 for more information about the recall of Lotronex.