Like a phoenix rising from the ashes, the prescription drug Lotronex is about to return to drugstore shelves. This kind of resurrection is unprecedented in FDA history.
Lotronex was approved for sale in February of 2000 as the first medication for relieving diarrhea associated with irritable bowel syndrome. People with this condition may suffer with painful cramps and explosive diarrhea.
Not long after Lotronex reached the market, however, reports of serious constipation emerged. There were several cases of “ischemic colitis,” a condition in which blood flow to the colon is compromised, leading to damage and inflammation. A handful of deaths were reported.
As a result of these complications, the FDA called for a “voluntary” recall and Lotronex disappeared. Normally, once a drug is withdrawn from the market it never reappears. But Lotronex should be back within several weeks.
What happened to make the FDA reconsider its position? Patients overwhelmed the agency with letters, emails and personal testimony about their tribulations.
Many described diarrhea-predominant IBS as a nightmare. One woman testified that “by the time I was a senior in college I knew that life would never be normal.IBS impacted every aspect of my life-career, education, relationships, marriage and parenthood-all had to be rearranged.”
Victims of this condition describe being “prisoners in their own homes.” They fear going anywhere a bathroom might not be readily accessible. Uncontrollable diarrhea can result in humiliating accidents. Patients often become withdrawn, anxious or depressed.
Lotronex changed many lives. One reader related that after suffering with irritable bowel syndrome for years, her doctor prescribed Lotronex. “It was the ideal solution for me. Then this drug was taken off the market and I was devastated. I saved enough pills to be able to go on vacation, but when they ran out my IBS came back as bad as ever. Is there any hope this drug will come back on the market? I need it!”
This kind of plea and thousands like it swayed the normally unmovable FDA to negotiate conditions for bringing Lotronex back to the marketplace. A risk-management program will help to ensure that both patients and physicians will be well-informed about the appropriate use and possible dangers of the drug.
The main complications from Lotronex are severe constipation or ischemic colitis, so anybody taking Lotronex will need to be on guard against new or increased pain in the bowels or blood in the stool. At the first sign of constipation patients must stop the medicine and contact the physician. Only women will be eligible for the drug under this restricted re-introduction.
As the FDA’s deputy commissioner, Dr. Lester Crawford, admits, “All drugs have risks. It’s the FDA’s job to balance the need for access to effective medications with those risks.”
Patient power is responsible for getting Lotronex back on the market. And patients using the medicine will need to acknowledge and attend to the serious risks this drug carries so that they can continue to reap its benefits.
