ORGANON's MAXIBOLIN AND SEARLE's ANAVAR EFFICACY IS UNSUBSTANTIATED, FDA's

ORGANON's MAXIBOLIN AND SEARLE's ANAVAR EFFICACY IS UNSUBSTANTIATED, FDA's Endocrinologic & Metabolic Drugs Advisory Cmte. concluded at its Jan. 24 meeting. "There appears to be a concensus that we have been presented with no evidence of efficacy to support the indications that are listed in the current inserts," Cmte. Chairman Joseph Lowenstein, MD, Louisiana State University, declared. The conclusion followed a presentation by FDA reviewer Samarendra Dutta, MD, and subsequent cmte. review of the data in the FDA files on the two anabolic steroids. A review of existing data was conducted by FDA's Metabolic & Endocrine Div. "because of recent adverse safety data and widespread use of anabolic steroids for unapproved indications," Dutta explained to the cmte. FDA now believes, Dutta said, that "evidence from adequate and well-controlled studies are lacking for use of [the two drugs] in all of the indications mentioned in their current package inserts." FDA Metabolism & Endocrine Div. Director Solomon Sobel, MD, explained the regulatory background on anabolic steroids to the cmte. "We have a situation of a rapidly narrowing marketing of anabolic steroids, and the indication picture also is narrowing progressively as years go on," Sobel said. Besides Maxibolin and Anavar, there are four other anabolic steroids remaining on the U.S. market: nandrolone phenpropionate (Organon's Durabolin), approved for treatment of breast cancer, nandrolone decanoate (Organon's Deca-Durabolin), for anemia of renal failure, oxymetholone (Parke-Davis' Adroyd and Syntex's Anadrol), for aplastic anemia, and stanozolol (Winthrop's Winstrol), which is being studied for osteoporosis and has applications pending for hereditary angioedema and for fibrinolytic enhancement. Addressing the "rather difficult regulatory situation" of Anavar and Maxibolin, Sobel explained to the cmte. that they were the only anabolic steroids introduced through the post-1962 NDA process, and were therefore not specifically subject to the DESI review process and its determinations regarding that class of drugs. However, Sobel said, "we feel that it is reasonable to reopen this consideration [of the efficacy of Anavar and Maxibolin], even in view of the fact that at one point there was an NDA granted, in view of the realization over the years that anabolic steroids are certainly not innocuous drugs, and that the risk/benefit considerations in regard to their use needs some reevaluation at this point." FDA, Sobel said, asked Searle and Organon "to present as strong a case and data base as they have, and they have not been forthcoming. They have relied primarily on the fact that in the agency some 19 years ago a decision was made on the data base [in the FDA files] which we feel at this point is not adequate in view of the safety issues that have subsequently arisen." Sobel pointed out that "the pharmaceutical manufacturers will have an opportunity to present further data if they feel we have not considered the proper data base, and this will be done through the hearing process."

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