Irritable Bowel Drug May Come Back
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."