U.S. government health officials on Wednesday began cracking down on Internet sales of custom-mixed hormones for menopausal women, a market born when doctors deemed prescription estrogen therapy too risky for many.
But the Food and Drug Administration says these alternative hormone mixes are no safer, and told seven makers to stop claiming they are. In addition the agency said some of the products contain the unapproved ingredient estriol, which cannot be sold legally.
The FDA said it sent warning letters to the companies saying their claims about the "bio-identical hormone replacement therapy" or BHRT products are not supported by medical evidence and are considered false and misleading.
"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," Dr. Janet Woodcock, FDA's chief medical officer, said in a statement.
The agency said it is concerned that the claims for safety and effectiveness mislead patients, as well as doctors and other health care professionals.
In addition to menopausal use, some pharmacies were claiming the products could prevent or treat serious diseases, including Alzheimer's disease, stroke and various forms of cancer, the agency said. Officials said there is no credible evidence to support those claims.
Dr. Kathleen Uhl of the agency's office of women's health said that while FDA does not have any statistics about how widespread the use of these drugs is, it has received a growing number of questions about them indicating increased interest.
Women need to know that all products have benefits and they have risks and discuss those with their doctor, Uhl said.
FDA urges women to the lowest effective dose of hormone replacement drugs that it has approved for menopausal symptoms.
Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible, the agency said.
The warning letters say the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.