UPDATE 1-US FDA: 'Bio-identical' hormone claims unsupported
(Adds FDA quote, comment from pharmacy group)
WASHINGTON, Jan 9 (Reuters) - U.S. health officials warned seven pharmacy operators on Wednesday that their claims about the safety and effectiveness of "bio-identical" hormones were false, misleading and not supported by medical evidence.
The pharmacies claimed their hormone products were superior to approved menopause therapies and could be used to prevent and treat serious conditions such as Alzheimer's, strokes and cancer, the Food and Drug Administration said.
"FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals," an agency statement said.
Drugmaker Wyeth (WYE.N: Quote, Profile, Research, Stock Buzz), which sells FDA-approved hormone replacement therapy, had petitioned the agency to take action against makers of bio-identical hormones.
Bio-identical hormones are made by so-called compounding pharmacies that tailor medicines to particular patients when doctors deem FDA-approved versions inappropriate.
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.
"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. Continued...






