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Fri Jun 7,10:06 PM ET
By LAURAN NEERGAARD, AP Medical Writer
In an unprecedented move, the government is again allowing sales of a drug that was pulled off the market after causing seven deaths heeding the pleas of patients suffering from irritable bowel syndrome.
"We're not anticipating with this program that the risk will go away," acknowledged FDA gastrointestinal drugs chief Dr. Victor Raczkowski. "The goal ... is to have the drug prescribed in patients for whom the benefits of the drug exceed those risks."
That includes patients miserable from severe abdominal pain, diarrhea, and having to wear diapers to guard against bowel accidents who must have failed other therapies. They must understand Lotronex side effects could hospitalize them, lead to major intestinal surgery, even kill.
Patients who called Lotronex a miracle praised FDA's decision, announced Friday.
"A catastrophic mistake was averted and individuals can now breathe a sigh of relief," said Jeffrey Roberts of the IBS Self Help Group.
Roberts is pursuing a loophole, hunting a doctor who'll prescribe Lotronex for him. The FDA cautions the drug hasn't been proven safe or effective for men, but it didn't actually block male use.
The FDA has no way to track Lotronex users or force doctors and pharmacists to follow the new rules, complained pharmacist Larry Sasich of the consumer group Public Citizen, which had lobbied for tighter restrictions of a drug studies found only modestly effective.
"I'm really afraid" more patients will be harmed, he said.
How big are the risks? Warning brochures every patient is supposed to read say one of every 350 women who take Lotronex may suffer intestinal inflammation called ischemic colitis, and one of every 1,000 could suffer severe constipation. There's no information about risk to men.
Patients will be urged to see a doctor immediately if they have any symptoms of side effects, such as constipation, unusual abdominal pain or blood in the stool.
"Only the future will tell in terms of do patients really understand this," said Nancy Norton of the International Foundation for Functional Gastrointestinal Disorders, a patient advocacy group.
Manufacturer GlaxoSmithKline aims to resume sales before year's end, after finalizing the marketing rules and restarting production.
In February 2000, Lotronex was lauded as the first new therapy in decades for irritable bowel syndrome, which afflicts millions of Americans, mostly women.
Just nine months later, Glaxo pulled Lotronex off the market because of severe side effects that the FDA says hospitalized 163 people, caused 51 to undergo major surgery and killed at least seven.
It's unprecedented for a drug withdrawn for safety reasons to sell again. But FDA had wanted restricted sales, not a ban, all along, and Glaxo renegotiated after patients protested.
Under the new program:
_Lotronex is to be prescribed only by doctors who enroll in a Glaxo program by pledging they can properly diagnose IBS and understand the drug's risks.
Critics had urged that only gastroenterologists specially trained to use Lotronex be enrolled. The FDA wouldn't say Friday what it would do if doctors lie about their experience to enroll.
_Doctors must promise to report all side effects. FDA's advisers had urged that every patient be enrolled in a registry to ensure tracking of side effects.
_Only the sickest female patients, fewer than 5 percent of sufferers, who failed other therapies should get Lotronex. Also, Lotronex is only for IBS that causes diarrhea, not constipation. The FDA didn't specifically prohibit doctors from giving it to men or less sick women.
_Patients must sign a form agreeing to Lotronex treatment.
_Patients must return to the doctor for every refill. The FDA rejected calls to limit each prescription to a 30-day supply, saying that the frequency of refills should be an individual decision.
_Patients should try using 1 milligram a day, half the originally recommended dose.
_Pharmacists are to fill only prescriptions bearing a special Glaxo sticker showing an approved doctor wrote the prescription and the patient signed the Lotronex agreement.
What if pharmacists break that rule? Glaxo said state pharmacy boards could sanction them, but wouldn't say if the company would turn in violators.
On the Net:
Food and Drug Administration: http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm
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