I guess Wyeth just doesn't want to share a tiny percentage of their 8 billion dollar a year revenue from their FDA approved, risk laden hormone replacement therapy.
FDA Cracks Down on Custom-Made Hormones
Jan 9 2008 2:45PM EST
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 selling them.
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.
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.
Following a 2002 study that found replacement hormones made by drug
companies raised the risk of heart attacks, breast cancer and
strokes, many women turned to the estrogen, progesterone and
testosterone products sold by compounding pharmacies.
Medical researchers concluded in 2003 that hormone replacement pills
should be taken only as a brief treatment to help women weather the
worst symptoms of menopause.
The drug company Wyeth later complained to the FDA about the Internet
sales of compounded products.
