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.
Regards,
Catherine
You don't drown by falling in the water.
You drown by staying there.
.