June 7, 2002

Allowing Lotronex Back on the Market Will Endanger Patients

Drug Reintroduction Program Weak; Offers Little Protection or Oversight

WASHINGTON, D.C. - Reintroducing Lotronex onto the market as announced today by the U.S. Food and Drug Administration (FDA) will endanger patients, Public Citizen said today. Not only is the new marketing program too lax to prevent harm, but it is to be overseen by the company that makes the drug - a poor idea because the company has a financial incentive to downplay problems with the drug. Also, the recommended dose has not been shown to be effective.

Lotronex, approved in February 2000 to treat irritable bowel syndrome (IBS) for women with diarrhea as the predominant symptom, was withdrawn from the market in November 2000 because of dangerous adverse effects experienced by some patients taking it. Public Citizen in August 2000 petitioned the FDA to remove the drug because of evidence that it caused ischemic colitis, a life-threatening condition in which bowel tissue dies as a result of a lack of blood flow to the colon. Many patients were hospitalized and suffered permanent injuries.

Today, the FDA announced plans to reintroduce Lotronex at a recommended dose of 1 milligram (mg) per day. However, studies conducted prior to the original approval showed no evidence that the 1 mg daily dose is significantly better than a placebo. Further, the trials showed an increased risk of adverse effects at the 1 mg dose - a four-fold increase in constipation severe enough to cause the patients to withdraw from the study - compared with placebo. Thus, the newly approved starting dose of 1 mg per day lacks the proper evidence of efficacy required by the 1962 FDA Drug Efficacy Amendments but causes a significantly greater incidence of severe constipation. In addition, in 12 percent of the first 70 cases of ischemic colitis reported to the FDA, the patient was using the 1 mg per day dose approved for the new marketing plan.

Under the guidelines announced today, physicians who want to prescribe the drug must state that they are qualified to diagnose IBS and manage ischemic colitis and that they understand the risks associated with Lotronex. The doctors also must promise to educate patients about the risks and obtain their signatures on a patient-physician agreement.

However, no one is required to verify the doctors' qualifications or check to ensure patients have been informed of the drug's risks. Further, there will be no mandatory tracking of patients to see if they develop adverse effects. Finally, the entity administering the program will be GlaxoSmithKline, the drug's manufacturer.

"This is a classic case of the fox guarding the hen house," said Larry Sasich, a pharmacist and research analyst with Public Citizen's Health Research Group. "GlaxoSmithKline has a huge stake in this drug and wants it to succeed. The company should not be overseeing the patient safety program."

Instead, the FDA should have limited the drug to research status, which requires tight controls on who receives a drug and documentation of the effectiveness and safety of a drug. Under that status, the FDA should have limited the drug to women who had previously used it and experienced no adverse effects, Sasich said.

Also, at a minimum, the risk management program should be restricted to registered gastroenterologists, Sasich said. There should be a patient registry, and the pharmacies that dispense the drug also should be registered with the FDA.

"We are quite fearful for patients," Sasich said. "Unfortunately, the FDA's action will almost surely lead to more injuries and possibly deaths associated with this drug."

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