On Wednesday the FDA sent letters to seven pharmacies ordering them to stop making false and misleading claims about custom-made “compounded” hormone products sold over the Internet to treat menopause. Claims that these synthesized hormones are more effective than approved menopause therapies are false according to the FDA and other experts. The FDA said in the letters that the claims made by the companies are a violation of federal law. The letters also told these companies that they couldn’t sell hormone mixtures containing estriol, which has not received FDA approval.
According to USA Today, the use of bioidentical hormones increased following a 2002 study that found brand-name drugs produced by pharmaceutical companies increased the risk of breast cancer, heart attack and stroke (Appleby/Szabo, USA Today, 1/10). FDA is being sued by compounding pharmacies, which argue that the agency doesn’t have authority to regulate compounded drugs, and an appeal in the case is scheduled to be heard on Thursday, the Journal reports (Wall Street Journal, 1/10).
Anyone buying unapproved medicines online should be weary of claims made by the manufacturers. Remember they are trying to sell you their product.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.