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Published on 11 January 2008

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FDA in warning on custom hormones

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The Food and Drug Administration (FDA) has launched a crackdown on pharmacists who sell custom-made hormones for menopausal women over the internet.

The regulator has sent warning letters to seven organisations ordering they stop claiming the compounds are safer than prescription oestrogen therapy.

The FDA also said some mixes contain estriol, which is illegal to be sold in the US because the watchdog has not approved it for use.

In letters to the pharmacies, the FDA said the claims about the “bioidentical hormone replacement therapy” (BHRT) products are not supported by medical evidence, and that the operations are breaking the law by making misleading claims about the drugs.

Dr Janet Woodcock, the FDA’s chief medical officer, said: “We want to assure that Americans receive accurate information about the risks and benefits of drug therapies.

“In addition to the regulatory action, FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies.

“Women taking these drugs should discuss with their healthcare providers the drugs’ risks and whether they’re getting effective treatment.”

The pharmacies warned are Panorama Compounding Pharmacy, Saint John’s Medical Plaza Pharmacy, Murray Avenue Apothecary, Village Compounding Pharmacy, Pharmacy Compounding Specialties, Reed’s Compounding Pharmacy, and Pacifica Pharmacy.

Copyright © PA Business 2008

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