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Medco mail-order drops hormones

Executive Summary

Medco's mail order pharmacy will cease dispensing compounded estrogen, testosterone and progestin products. In a letter to physicians acknowledging that "the practice of extemporaneous compounding remains controversial," the pharmacy benefit manager asks doctors to consider switching patients to an FDA-approved product. The firm cites claims from physician groups that compounded hormones have not been proven to be more safe or effective than marketed products. FDA is reviewing a Wyeth citizen petition requesting the agency stop pharmacists from compounding bioidentical HRTs (1"The Pink Sheet" Nov. 7, 2005, p. 11)...

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Oversight of hormone compounding

American Medical Association House of Delegates requests Nov. 14 that FDA review the formulations of all compounded bioidentical hormone formulations. "Since the final hormone formulations of most compounding pharmacies are not subject to FDA monitoring for dose, purity, safety, or efficacy, there may be additional, and at this point unknown, risks associated with them," AMA says. Association is also asking FDA to require adverse event monitoring and patient information for bioidentical formulations. Medco recently stopped dispensing compounded estrogen, and Wyeth is pressing FDA to block pharmacists from producing the products (1"The Pink Sheet" Oct. 9, 2006, In Brief)...

Wyeth Urges Halt to Hormone Compounding, Questioning Its Safety

Wyeth's citizen petition to the FDA urging it to stop compounding pharmacists from producing "bioidentical hormone replacement therapy" focuses on safety concerns about the practice

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