FDA says alternative hormone claims unsupported

FDA says alternative hormone claims unsupported
Wed Jan 9, 2008



By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials said on Wednesday they had warned seven pharmacies selling "bio-identical" hormones over the Internet that they were breaking the law with false and misleading claims about the benefits for menopausal women.

The Food and Drug Administration sent letters ordering the pharmacies to stop claiming their hormones were better than approved menopause therapies and could prevent and treat serious conditions such as Alzheimer's, strokes and cancer.

FDA officials said there was no reliable scientific evidence to support the assertions.

"Claims like these mislead consumers and health-care providers with inaccurate information," said Deborah Autor, director of compliance in the FDA's drugs center.

Interest in the products grew after a 2002 finding that FDA-approved hormone products raised the risk of heart disease, blood clots and certain cancers.

Drugmaker Wyeth, which sells FDA-approved hormone replacement therapy, had petitioned the agency to take action against makers of bio-identical hormones.

FDA officials said there was no evidence the bio-identical hormones were any safer than approved versions of the hormones estrogen and progesterone. The alternative versions are made in so-called compounding pharmacies that are allowed to produce custom-made medicines for patients with a doctor's prescription.

The agency said some products contained the unapproved hormone estriol and it was prepared to take action to halt sales of those products.

The pharmacies warned by the FDA were: Panorama Compounding Pharmacy, Saint John's Medical Plaza Pharmacy, Murray Avenue Apothecary, Pharmacy Compounding Specialties, Reed's Compounding Pharmacy and Pacifica Pharmacy.

Other pharmacies also sell bio-identical hormones, but FDA officials said they could not say how many.

The FDA objected to the term "bio-identical," saying it wrongly implied the hormones are natural or the same as ones made by the body, and therefore safer. Companies say the compounded hormones are derived from plants such as soy and yams.

The agency said it did not want to discourage legitimate compounding in the absence of unsupported claims. Officials advised women to talk with a doctor to determine if compounded drugs are their best option.

Compounded drugs are not reviewed by the FDA for safety and effectiveness, and the agency said it encouraged patients to use agency-approved medicines whenever possible.

The International Academy of Compounding Pharmacists said the FDA action would deny many women access to products that may help them when approved therapies do not or cause side effects.

"Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate ... This is a decision that should be left to doctors," L.D. King, executive director of the pharmacists' group, said in a statement.

"We intend to fight this," King added in an interview.

Phil Pylant, owner of Village Compounding Pharmacy, said his company simply followed doctors' instructions when providing the hormones and did not make any health claims. He said the company would comply with legal obligations.

"We don't break the law here," he said.

Officials at the other pharmacies could not immediately be reached or referred questions to the compounding pharmacists' group.