The U.S Food and Drug Administration announced that it sent out warning letters to seven pharmacy operations that had made claims about the safety and effectiveness of their "bio-identical hormone replacement therapy" (BRHT) products which were unsupported by medical evidence.
The FDA considers the claims to be false and misleading and is concerned that the unfounded claims are misleading to women and health care professionals. The pharmacy operations' claims include that their drug, which contains hormones such as estrogen, progesterone and estriol (which has not been proven safe by the FDA) are better than FDA approved hormone replacement therapies and that the drug also treat diseases such as Alzheimer's disease, stroke and different types of cancers.
"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," said Dr. Janet Woodcock, FDA's chief medical officer and acting director of the agency's Center for Drug Evaluation and Research. "In addition to today's 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 health care providers the drugs' risks and whether they're getting effective treatment."
Pharmacy operations that do not address the issues presented in the FDA warning letters may face further action such as injunctions to prevent further violations and seizure of the drugs that are in violation of federal law.
The FDA has release a consumer article called: Bio-Identicals: Sorting Myths from Facts to better inform the public as to the dangers of "bio-identicals" which the FDA considers a marketing ploy with no medical or scientific basis.
[Source: FDA]
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