Return of the Controversial Bowel Drug
Pulled After Deaths, Lotronex Is Back -- With Strict Limits on Use
How many people will take the drug? Eric Carter, MD, vice president of gastrointestinal clinical development for GlaxoSmithKline, says he doesn't know.
"Our hope is that there is a significant number of patients who might benefit," Carter tells WebMD.
There may well be quite a few. One in 10 women suffer from IBS diarrhea. Many of these women get little help from available treatments. However, only 1 in 20 people with IBS has severe disease, and not all of these people have diarrhea-predominant IBS.
When the FDA's advisory board met in April 2002 to consider Lotronex reapproval, 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 in writing.
"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 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 GlaxoSmithKline's request to re-introduce this horrible drug."