August 2, 2006

Hormone Replacement Therapy Drugs Mixed by Pharmacies Are Unsafe, Public Citizen Reveals on WorstPills.org Web Site

“Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

WASHINGTON, D.C. – Hormone replacement drugs that are mixed by pharmacies – a process known as “compounding” – are unsafe, and women should avoid them, Public Citizen writes in a new August posting on its WorstPills.org Web site.

Serious safety concerns were long ago raised about hormone replacement therapy (HRT) products approved by the Food and Drug Administration (FDA). Women should be especially wary of all so-called Bioidentical Hormone Replacement Therapy drugs (BHRT) compounded by pharmacies due to the safety issues and their lack of    FDA regulation.

Pharmaceutical company Wyeth, manufacturer of estrogen replacements Premarin and Prempro, has filed a petition with the FDA to stop pharmacies from compounding the drugs. Wyeth has a financial stake in ending production of compounded BHRT drugs because pharmacies can produce and sell compounded versions of the drug more cheaply without FDA regulation.

According to the FDA, pharmacy compounding “involves making a new drug whose safety and efficacy have not been demonstrated.” The FDA has expressed concern in some cases about the quality of the drugs being compounded and the potential risks to patients who may take them.

Studies have shown that Wyeth’s HRT drugs – which have received FDA approval –   increase the risk of cancer, stroke and blood clots when used long-term in postmenopausal women. Information on the adverse effects of pharmacy-compounded BHRT is not available because compounded drugs are not regulated by the FDA. Both compounders and Wyeth have claimed that their products are safe because they are “natural.” Conjugated estrogens, the active agent in Premarin, are also natural and, in fact, are derived from the urine of pregnant horses. However, while the ingredients in BHRT are “natural,” they are not “natural” to humans.

“The FDA has done nothing to warn women about the dangers of compounded hormone replacement therapy drugs,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “This is yet another example of the FDA’s failure to fulfill its mission of protecting the health of American patients.”

The August updates to the WorstPills.org Web site also give consumers information about birth defects in children born to women using angiotensin-converting enzyme (ACE) inhibitor blood pressure medication during the first trimester and liver toxicity linked to use of the dietary supplement black cohosh.

Worst Pills, Best Pillsis a monthly newsletter available in print and electronic formats through Public Citizen’s Web site, www.WorstPills.org. The article about compounded BHRT drugs will be available free on the site until August 7, 2006. The site has other searchable information about the uses, risks and adverse effects associated with prescription medications, including all the information contained in Public Citizen’s best-selling 2005 book, Worst Pills, Best Pills.

Worst Pills is an unbiased analysis of information from a variety of sources, including well-regarded medical journals and unpublished data obtained from the FDA that allow Public Citizen to sound the alarm about potentially dangerous drugs long before they are banned by the federal government.

The www.WorstPills.orgWeb site is particularly valuable because Public Citizen has a strong track record of identifying dangerous drugs and warning readers well before federal regulators take action to ban or place warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid and why people should not use these drugs years before they were pulled from the market.

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