Last week, FDA warned last week seven compounding pharmacies to cease marketing estrogen/progestin products containing estriol.

by Peggy Peck, Executive Editor, MedPage Today

Rockville, Md., Jan. 9
 — The FDA today warned seven compounding pharmacies to cease marketing estrogen/progestin products containing estriol.

Moreover, the FDA warned the pharmacies to stop claiming that the compounded products could be used to treat Alzheimer’s disease, breast cancer, depression, and colon cancer, and to stop using the “non-scientific term ‘bio-identical’, which leads to misbranding of the drug,” said Steve Silverman of the FDA’s Office of Compliance.

The seven pharmacies are Panorama Compounding Pharmacy of Lake Balboa, Calif.; Saint John’s Medical Plaza Pharmacy of Santa Monica, Calif.; Murray Avenue Apothecary of Pittsburgh; Village Compounding Pharmacy of Houston; Pharmacy Compounding Specialties of Dallas; Reed’s Compounding Pharmacy of Tucson; and Pacifica Pharmacy of Torrance, Calif.

The seven pharmacies were targeted after an FDA review of their Websites revealed that they were marketing products with estriol, an estrogen produced during pregnancy that has not been FDA approved for clinical use. The FDA review also identified the “patently false claims,” said Silverman.

The compounded products are prescription only, so the FDA warning letters are also aimed at physicians who prescribe the products, said Kathleen Uhl, M.D., of the FDA’s Office of Women’s Health.

Dr. Uhl added that the FDA did not intend to discourage use of compounding pharmacies, which fill a need for patients who may need specially tailored medications. These include, for example hormone replacement in vehicles (cream) versus pills or an oral medication without dye.

Rather, the FDA “wants this to be conversation between a woman and her doctor that is based on the best scientific information available.”

Deborah M. Autor, director of the Office of Compliance, said that the FDA was not opposed to the use of hormone replacement products compounded by pharmacies using only approved estrogens and/or progestin.

A major problem with the products from the seven targeted pharmacies was the use of estriol, “which is not FDA approved and has never been subject to safety studies by the FDA,” Autor said.

Dr. Uhl said the FDA had no data on the use of the estriol containing products, nor did it have any data on the overall use of compounded hormone replacement products.

“But there has been a great increase in inquiries about these products since the [July 2001 release of data from the Women’s Health Initiative study linked estrogen/progestin to increased risk of blood clots, strokes, and breast cancer],” she said.

Dr. Uhl also questioned the way in which the products were marketed, which she said promoted the idea that the compounded products “were natural and therefore safer than FDA approved hormone replacements.”

Although the FDA has never conducted safety tests on drugs made by compounding pharmacies, “there was no reason to believe that the risks of compounded estrogens and progestins would be any different than the risk reported for FDA-approved hormone replacement drugs.”

Silverman said that today’s action was the result of an ongoing FDA review of compounding pharmacies and was solely in response to a 2005 citizen’s petition from Wyeth Pharmaceuticals, which asked the FDA to crack down on the hormone replacement products marketed by compounding pharmacies.

Wyeth petitioned the FDA to “initiate enforcement actions” against the compounding pharmacies. Silverman said the FDA denied that request because requesting enforcement action was not within the scope of citizen petitions.

But the FDA said Wyeth requested a public education campaign and the FDA has granted that request by today’s action as well as by posting a consumer education article on the FDA website.

Since the Wyeth petition was published in the Federal Register in October 2005, it has generated 70,000 responses, including about 15,000 that were “boilerplate” responses generated by mass emails. Silverman declined to say how the responses stacked up — for or against the Wyeth position — stating only “there were responses from both sides.”

The FDA said the pharmacies have 15 days to stop the objectionable practices cited in today’s warning letter. The FDA will initiate enforcement actions against pharmacies that do not comply within that time limit, Autor said.

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