# FDA/Lotronex



## Guest (Aug 25, 2000)

In case some of you didn't see:For the first time, the Food and Drug Administration has ordered a drug maker to distribute a plain-language warning letter through pharmacists to all patients using a prescription drug--a recently approved medication for women with irritable bowel syndrome.The novel step was required, the agency said yesterday, because of 19 serious complications from the drug Lotronex within four months of its approval in February. Ten of those adverse reactions required hospitalization and four required otherwise unnecessary surgery. One person lost her colon as a result, officials said.The agency has long required the distribution of a range of information to doctors prescribing drugs. But the Lotronex "Medication Guide" marks the first time that pharmacists will be required to attach an FDA-approved letter outlining the risks of the drug to each prescription filled. The FDA was given authority to require the mandatory guides late in 1998.The agency also assembled an advisory commit!tee in June--four months after the drug was approved--to address the Lotronex complications."This is part of an increased awareness on our part to actively manage the risks of the drugs once we become aware of them," said Victor Raczkowski, deputy director of the FDA's office of gastrointestinal drugs. "Rather than wait for definitive, perfect data, we are attempting to act once we have a warning signal."Doug Stokke, a spokesman for Glaxo Wellcome Inc., manufacturer of the drug, said that the company was "certainly committed to product labeling that clearly describes which medications are appropriate for patients." About 230,000 people have used the drug since it was introduced early this year, he said.Irritable bowel syndrome (IBS) is an abnormality of the gastrointestinal tract that affects an estimated 15 percent of the population, and occurs two to three times as often in women as men. People suffering from the condition experience chronic or recurrent pain in the lo!wer abdomen, irregular bowel movements including diarrhea and constipation, or both.Lotronex was initially approved for women with the diarrheal form of IBS--since it was not found to be effective for men--but officials said at least one of the patients who had a serious adverse reaction was male.The primary complications have been severe constipation and ischemic colitis, a reduction of blood flow to the gut that can cause severe pain and bloody stools. While other medications on the market treat IBS, Lotronex is claimed to be the only one to treat both symptoms of diarrhea and abdominal pain.Earlier this year, the FDA withdrew two drugs after concluding they were too dangerous for the benefits they provided.The agency was sharply criticized by the pharmaceutical industry during the early 1990s for taking too long to approve drugs; now it is under increasing criticism from public health groups for moving too quickly to approve new drugs and too slowly to take them off!the market when they are found to have serious medical complications.The new "Medication Guides" are part of an effort to find new ways of responding to reported drug complications."Today's actions are an important milestone in enabling consumers as well as health care professionals to better manage the risks that are inherent in even very beneficial drug treatments," said FDA Commissioner Jane E. Henney.But a consumer advocacy group said yesterday that the consumer guide wasn't enough because Lotronex offers only modest relief for a condition that is not life-threatening, while the possible complications are."We believe this drug should come off the market, and will file a petition in the next few weeks to get it off," said Sidney Wolfe of the advocacy group Public Citizen, who said he fears a patient will soon die of the complications. "The drug should never have been approved."


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## JeanG (Oct 20, 1999)

Thanks for posting this, Chrissy.JeanG


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## Guest (Aug 25, 2000)

You are welcome Jean -- I feel horribly for anyone who actually was feeling better because of this drug...of course I feel worse for those who have had such serious side effects.


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## Guest (Sep 6, 2000)

Chrissy:Why would you feel horribly for anyone who was feeling better taking this drug? Lotronex has done wonders for me. And despite the side effects listed, I plan to continue taking it.Any new meds should be monitored with your doctor. If people use common sense, they should be fine. No one knows my body better than me, and I know what is normal and what isn't. I pray the FDA doesn't remove Lotronex from the market as it has given me my life back.------------------Female (IBS-D)- On Lotronex since 3/00 - current dosage 1/2 pill daily - Doing great!!!


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