FDA Warns of Bowel Treatment Effects
Monday, August 28th 2000, 12:00 am
By: News On 6
WASHINGTON (AP) â€” A popular new treatment for irritable bowel syndrome could cause severe intestinal side effects â€” some requiring surgery â€” that have already affected at least 19 women.
The Food and Drug Administration announced Thursday it had ordered Glaxo Wellcome Inc. to attach to every bottle of Lotronex a plain-English pamphlet explaining the risk, and that women should stop taking it at the earliest sign of a problem.
Women have reported either a potentially life-threatening intestinal inflammation called ischemic colitis or severe constipation, and the FDA has preliminary reports of another 14 cases since Lotronex hit the market six months ago.
Some cases apparently were caused by doctors giving Lotronex to women who shouldn't have taken it, sparking the FDA to order the unprecedented straight-to-the-patient warning brochures called ``MedGuides.''
The FDA, shaken by a recent spate of drugs that had to be banned, is hunting new ways to swiftly counter side effects of newly approved prescription drugs. Lotronex will test whether the MedGuides help.
A consumer advocacy group, however, called the move insufficient.
``We do think this drug should come off the market, and will file a petition to get it off,'' said Dr. Sidney Wolfe of the group Public Citizen, who said he fears a woman eventually will die of the side effects. ``The risks clearly outweigh the benefits.''
But the FDA counters that if patients learn the early signs of a side effect, they can stop taking Lotronex before they have trouble.
``This drug works in some people and it doesn't work in others,'' said Dr. Victor Raczkowski, FDA's deputy chief of gastrointestinal drugs. The new warning should ensure that ``the patients most likely to benefit from the drug and least likely to have serious side effects take it.''
Glaxo also is mailing a warning to thousands of doctors this week to help reduce the number of prescriptions physicians are improperly writing for women who shouldn't use the drug, said vice president James Palmer.
Lotronex is the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15 percent of Americans, mostly women. IBS involves chronic or recurrent abdominal pain, the sudden and urgent need to go to the bathroom and either frequent diarrhea or constipation or both.
Lotronex offers modest relief to women whose main IBS problem is diarrhea. It doesn't work for men.
About one of every 700 Lotronex users will develop ischemic colitis, says the new MedGuide. Also, the drug can cause constipation so severe that patients need hospitalization, even surgery, to unblock their intestines. In the worst case, one patient needed her colon removed.
The FDA's top warnings:
â€”Do not ever take Lotronex if you are constipated most of the time or ever have had severe constipation. If you have severe or worsening constipation while taking Lotronex, stop using it immediately and call your doctor.
â€”Stop using Lotronex and call your doctor immediately if you have new or worsening pain in the lower abdomen, bloody diarrhea or blood in the stool. These are early symptoms of ischemic colitis.
â€”Because Lotronex does not cure IBS or work for everyone, quit using it if your symptoms do not improve within four weeks.
â€”Do not take Lotronex if you have ever had ischemic colitis or such other intestinal disorders as Crohn's disease, ulcerative colitis or active diverticulitis.
On the Net: The MedGuide for Lotronex is available on Glaxo's Internet site, http://www.lotronex.com.