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FDA approves restricted re-marketing of Lotronex

FDA approves restricted re-marketing of Lotronex...

ROCKVILLE, MD. -- The Food and Drug Administration (FDA) has announced the approval of a supplemental New Drug Application (sNDA) that permits marketing of Lotronex (alosetron hydrochloride) with restrictions.

Manufacturer GlaxoSmithKline will be implementing a risk management program, including a prescribing program, to enroll physicians who wish to prescribe Lotronex.

The drug's indication has been narrowed to cover only treatment of women with severe, diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed to respond to conventional IBS therapy. Limiting the use of Lotronex to this severely affected population is intended to maximize the benefit-to-risk ratio.

Marketing of Lotronex is being restricted because serious and unpredictable gastrointestinal adverse events, including some that resulted in death, were reported in association with its use when it was previously marketed.

Less than 5 percent of IBS is considered severe, and only a fraction of severe cases are diarrhea-predominant IBS. Severe IBS is a chronic condition (in this case, generally lasting more than 6 months) with symptoms that disable or significantly curtail the daily activities of patients. Symptoms typically include frequent and severe abdominal pain and fecal incontinence or the uncontrollable urge to have a bowel movement.

The required risk management program is designed to help ensure not only that patients and physicians are fully informed of the risks and benefits of Lotronex prior to using it, but also that only appropriate patients are prescribed the drug. Therefore, the program emphasizes the need for doctors, patients and pharmacists to work together to maximize the benefit of Lotronex, and minimize the risk. Here's how it will work:

  • GSK will establish a prescribing program for Lotronex to enroll physicians who plan to prescribe Lotronex.
  • Enrollment will be based on physician self-attestation of qualifications.
  • GSK will enroll in the prescribing program physicians who agree to educate patients on the risks and benefits of Lotronex treatment, and to provide patients a copy of the FDA-approved Medication Guide.
  • Patients will be asked to read and sign a Patient-Physician Agreement before receiving their initial prescription for Lotronex.
  • Pharmacists will be asked to fill only prescriptions that display a prescribing program sticker affixed by an enrolled physician, and to give patients a copy of the FDA-approved Medication Guide every time they dispense the drug.

In addition, enrolled physicians will have agreed to report serious adverse events to GSK.

FDA first approved Lotronex in February 2000. Following post-marketing reports of, and a public advisory committee meeting about, serious and life-threatening cases of ischemic colitis and complications of constipation, including deaths, GlaxoSmithKline voluntarily withdrew Lotronex from the market in November 2000.

Although constipation and ischemic colitis were observed in the pre-approval clinical trials of Lotronex, serious complications of constipation and consequences of ischemic colitis were not seen until after marketing when many more people were exposed to the drug.

Additional information on Lotronex, including the revised professional and patient labels and physician and patient agreement documents, can be found on FDA's website at www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm.

Posted: June 2002


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