April 23, 2002 -- Is Lotronex a lifesaving remedy or a deadly drug? An FDA advisory committee today said it is both. It recommends resuming sale of the drug -- with strict limits.
Whether Lotronex maker GlaxoSmithKline will agree to the restrictions remains to be seen. The committee's final proposal has yet to be written, but it will certainly include limits to which the company has previously objected.
"At this point, I can't say for sure whether this drug will come back or not," Victor Raczkowski, MD, the FDA's deputy chief of gastrointestinal drugs, tells WebMD. "The majority of the committee thought it should be made available under a restricted marketing plan. There were a couple of votes from people that thought it should remain investigational. Nobody thought it should be freely prescribed."
Many patients say Lotronex has rescued their lives from the unrelenting diarrhea of severe irritable bowel syndrome (IBS). They say they've had a hard time since GlaxoSmithKline voluntarily took the drug off the market in November 2000. They want their drug back. They also want other patients to be able to get it.
The problem is that Lotronex can cause serious injury. And it can kill. After only eight months on the market, the FDA has reports of seven deaths strongly associated with taking the drug. More than 160 other patients were hospitalized with ischemic colitis -- blocked blood flow to the intestine -- or with serious complications from severe constipation. Many of these patients required surgery. Some remain permanently disabled.
"One thing that is clear is that there are no risk factors to identify what patients may be at risk for these events," Raczkowski says.
The company took the drug off the market after a meeting with the FDA. The meeting came after the watchdog group Public Citizen petitioned the FDA to ban the drug. Public Citizen doctors today testified that they still think the drug isn't worth the risk.
Key elements of the FDA panel's recommendation are:
- Only doctors who take special training should prescribe Lotronex.
- The drug will be given only to women with severe diarrhea -- and only to those for whom other treatments don't work. Men are excluded because clinical trials offer no evidence that the drug works for them.
- Only the sickest patients can get the drug.
- Patients will have to undergo rigorous examination to show that they do not suffer diarrhea from an illness other than IBS. For some patients, but not all, this will mean endoscopy.
- Patients must register with a national database that tracks how well the drug works and whether there are any side effects.
- Patients will start treatment at half the previously recommended dose for at least one month.
The committee's recommendation is not binding, but the FDA almost always follows such advice. It's not a small decision. As many as one in 10 women suffers from IBS diarrhea. Many of these women get little help from available treatments.
At today's meeting, a parade of patients testified that their lives would not be worth living without Lotronex. Many others, unable to attend because of IBS, submitted moving testimonials.
"After 10 long years of suffering relentlessly, [Lotronex] removed the anxiety, the fear, the shame. ... It was a second chance at life!" writes Liza Kenney, a member of the Lotronex Action Group, an IBS patient-advocacy organization. "The day Lotronex returns will indeed be the happiest day of my life and to countless other sufferers as well."
Others wrote to tell of their terrible experiences with the drug. Ann DuPre Royall took part in a clinical trial of Lotronex.
"I developed severe pain from constipation [and] nausea and I was doubled over in pain on the bathroom floor," Royall writes. "I was taken to [the hospital] where I spent two days. It left me so weak that it has taken me two years to feel better. ... Please do not give in to Glaxo SmithKline's request to re-introduce this horrible drug."