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BURROUGHS WELLCOME TO RELAUNCH ANTIDEPRESSANT WELLBUTRIN IN MID-JULY AFTER ABORTED LAUNCH IN 1986; FDA-APPROVED LABELING INCLUDES DATA ON SEIZURE RISK

Executive Summary

Burroughs Wellcome will relaunch Wellbutrin (bupropion HCl) in mid-July, just over three years after being pulled from the market, the company announced June 28. Shipments of Wellbutrin will begin July 10. The antidepressant drug will be available in bottles of 100 tablets in 75 and 100 mg doses at a price to wholesalers of $ 29.95 and $ 39.95, respectively. The company said the product is expected to be available in pharmacies "after July 23." Burroughs Wellcome voluntarily withdrew Wellbutrin from the market in March 1986 after a study revealed an increased incidence of seizures in nondepressed bulimic patients. * The approved labeling for Wellbutrin states the drug "is indicated for the treatment of depression." The indications section also notes: "A physician considering Wellbutrin for the management of a patient's first episode of depression should be aware that the drug may cause generalized seizures with an approximate incidence of 0.4% (4/1000). This incidence of seizures may exceed that of other marketed antidepressants by as much as fourfold." Wellbutrin is the first antidepressant approved since Lilly's Prozac (fluoxetine) approval at the end of 1987. In its first full year of sales, Prozac topped $ 100 mil. in 1988 and generated "more than 30% of antidepressant dollar sales in the U.S.," Lilly told New York analysts in May. Burroughs Wellcome is touting Wellbutrin as "the first in a new class of antidepressant drugs." The company says the drug is "classified as an aminoketone [and] chemically unrelated to tricyclics, monoamine oxidase inhibitors and other conventional antidepressants." Furthermore, the company asserted in its launch material that Wellbutrin is distinguishable from other antidepressant agents based on its side effect profile. "Unlike tricyclic antidepressants, Wellbutrin is not associated with orthostatic hypotension" and causes "no significant effects on pulse rate or systolic blood pressure," the firm said. In addition, the company noted that patients treated with the drug "experienced fewer anticholinergic effects . . . than are associated with amitriptyline or doxepin." Initially approved in December 1985, Wellbutrin was withdrawn from the market by Burroughs Wellcome in March 1986 because of an unacceptable rate of seizures in a small study of nondepressed bulimic patients. In April 1986, FDA's Psychopharmacologic Drugs Advisory committee recommended that Burroughs Wellcome conduct a comparative safety study to imipramine (Ciba-Geigy's Tofranil) to assess the seizure rate of Wellbutrin. However, FDA apparently felt that such a study was unnecessary. The Wellbutrin labeling indicates that the drug's fourfold seizure risk relative to other antidepressants "is only an approximate estimate because no direct comparative studies have been conducted." In order to relaunch the product, Burroughs Wellcome conducted a prospective survey of 3,341 patients to determine the incidence of seizures in the general population of depressed patients on Wellbutrin. The company included data from the survey in a labeling supplement submitted to FDA in December 1988. "This study confirmed that the incidence of seizures is four per 1,000 patients," the company said in a June 28 release. The study also showed that keeping the total daily dose below 450 mg/day and maintaining single doses below 150 mg may minimize the risk of seizure. After reviewing the new data, FDA cleared the relaunch in a May 30 letter. Sidney Wolfe, MD, Director of the Public Citizen's Health Research Group, expressed concern that although the drug is contraindicated for bulimia, bulimic patients may conceal the disorder from their doctors. "The [depressed] bulimic who hides that disease is thereby in the same risk category that they took the drug off the market for," Wolfe said. The study that prompted the drug's withdrawal from the market in 1986 showed that four out of 50 bulimic patients had seizures. Because Wellbutrin was among the late-December rush of drug approvals by FDA in 1985, the subsequent withdrawal of the antidepressant several months later drew the attention of the Intergovernmental Relations Subcommittee chaired by Rep. Weiss (D-N.Y.). In an investigation into some of FDA's approval decisions for drugs that later showed unanticipated side effects, the subcommittee reviewed the approvals of Wellbutrin and Hoechst-Roussel's antidepressant Merital (nomifensine), among others. Hoechst-Roussel withdrew Merital from the market in January 1986 because of an increasing number of hypersensitivity reactions among patients on the drug.

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