said Tuesday it will pull Lotronex, a promising treatment for irritable bowel disease, from the market at the request of the
Food and Drug Administration
following reports of serious side effects, including fatalities.
Lotronex, approved in the U.S. last February, was the first of a new class of treatments for the painful digestive condition that afflicts millions of people, mainly women. It was also one of the London-based drugmaker's most promising new products and one that analysts forecast could generate $1 billion or more in annual sales.
However, the drug was dogged by reports of serious side effects, including a handful of deaths, prompting the FDA to request the withdrawal. The company said it has not been determined whether the drug was directly at fault in the patient deaths.
Glaxo shares recently traded down $1.12, or 2%, to $57.75.
Glaxo said the company took the action "voluntarily" after it proposed a number of labeling changes and other measures designed to "educate" patients and physicians over side-effect management. But it said the FDA turned down its proposals.
"We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS outweigh the risks," said James Palmer, Glaxo's director of medical, regulatory and product strategy. "Thousands of women who have benefited from Lotronex will have to resort to therapies which did not adequately treat their symptoms in the past."
The FDA action is the latest in a spate of drug withdrawals in recent years, including Rezulin, a
drug for diabetes, and Propulsid, a
Johnson & Johnson
drug for ulcers. The actions prompted criticism that the agency is approving drugs too quickly after it speeded up its drug reviews in recent years. The agency was previously criticized for reviewing drugs too slowly.
The FDA cleared Lotronex for diarrhea-predominant irritable bowel syndrome in February, the first such drug for a condition that afflicts millions of people, causing irregular bowel movements, abdominal pain and bloating.
The company said about a half-million prescriptions had been written for the drug.