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" FDA Cracks Down on Drug Compounding"

August 29 , 2006

In searching for an alternative to hormone replacement therapy drugs like Wyeth’s Prempro—associated with an increased risk of cancer and other serious ailments—many women seek the help of compounding pharmacists who create bio-identical hormone combinations considered safer by many.

These compounded blends of hormones estrogen and progesterone are intended to provide relief from menopausal symptoms without the side effects posed by products such as Wyeth’s, which are made from horse urine.

For many years, the Food and Drug Administration has taken a “hands-off” approach to compounding pharmacists, who blend custom drugs using bulk ingredients. Compounding pharmacies offer a true benefit to many consumers, offering products that can feature lower doses for children or the absence of an ingredient that a patient is allergic to.

However, with increased pressure from Wyeth to control the compounding industry, which poses a clear threat to the drug company’s market share, the FDA has suddenly reversed its stance on compounding. Many argue this is another example of the FDA falling pawn to drug industry interests.

FDA crackdown

The FDA has pledged stricter oversight of the compounding industry. This month alone, the federal agency has issued three warning letters to compounding firms and has threatened to take additional action if their demands are not met.

In an effort to expand their jurisdiction to suit their agenda, the FDA now says that custom blended treatments are “new unapproved drugs.” This gives the agency power to regulate these drugs and the pharmacists who create them.

The compounding battle

Wyeth, through a citizen’s petition, is seeking tighter federal regulation of the compounding industry. They want to make it so that pharmacists are required to inform the public about the safety of custom-made hormone replacement therapies, which compete with the company’s products.

While Wyeth claims to seek such regulation in the name of public safety, it is blaringly clear to many that the company is belligerently guarding its bottom line.

In their defense, ten compounding pharmacists have argued in federal court that the FDA is amiss in treating compounded products as new unapproved drugs. The presiding US district judge has made comments indicating he will side with the compounders in his upcoming ruling.

This judgment is expected to have a ripple effect across the nation.

Compounded Hormone Replacement Therapy

One of the most popularly compounded drugs, called “Tri-est,” is a hormone replacement therapy combining three estrogens and progesterone, hormones which diminish with age. Some proclaim such drugs are safer than Wyeth products, which have been the target of several lawsuits claiming they increase the risk of cancer.

“There is extensive medical literature that says that you are better off taking something that is bio-identical to your body, as opposed to something that comes from an animal,” contends Stephen Bernardi, co-owner of Johnson Drug, a compounding pharmacy in Massachusetts.

The stakes are high for these compounders, who blend and dispense up to five percent of the nation’s prescription drugs.

For more information on Hormone Replacement Therapy contact us to confer with a lawyer.

More Hormone Replacement Therapy News...

Wyeth Sued Over Prempro Once Again

Studies Support Isoflavones for Hot Flushes

Rate of Breast Cancer Drops With Decline in HRT Use

New Study Differentiates Characteristics of Cancer in HRT Users

Is Bioidentical Hormone Therapy Safe?

Jury Rules Prempro Caused Breast Cancer In HRT Trial

Study: Hormone Replacement Therapy Raises Ovarian Cancer Risk

If you are currently taking hormone replacement therapy, the combination of estrogen and progestin, you are advised to contact your doctor IMMEDIATELY for hormone replacement therapy alternatives.

For more information on hormone replacement therapy alternatives and your legal rights, please contact a hormone replacement therapy lawyer.

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Over 16,000 women participated in a major clinical trial that was stopped because of the serious risks found to occur when using hormone replacement therapy including:

   •  Heart disease
   •  Breast cancer
   •  Strokes
   •  Blood clots





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