Domperidone for Parkinson's and Other Compound Medications May Not Require New FDA Approval

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U.S. District Judge Rob Junell, in Midland, Texas, ruled that customized compound medications, such as Domperidone, are not new, unapproved drugs that must be sanctioned by the U.S. Food and Drug Administration. Domperidone treats the nausea and vomiting associated with the treatment of Parkinson's disease. Domperidone has been available in Canada through such intermediaries as LePharmacy.com for more than 10 years.

Millions of Americans take customized preparations prescribed by physicians and mixed by compounding pharmacies instead of mass-produced, FDA-regulated drugs. One of these medications is Domperidone, used to treat gastric side effects associated with the treatment of Parkinson’s.

Domperidone works specifically by blocking dopamine receptors found in an area of the brain known as the “chemo receptor trigger zone” (CTZ). The CTZ starts to work when nerve messages from the stomach are received when an irritant is present. After the process has begun , messages are transmitted to another area of the brain, the vomiting centre, which in turn instructs the gut, causing the vomiting reflex.

Blocking the dopamine receptors in the CTZ prevents nausea from being transferred to the vomiting centre. This reduces the feeling of nausea and prevents vomiting. Domperidone is available through LePharmacy.com. The F.D.A. has not yet approved Domperidone for sale in the United States.

In a landmark ruling, U.S. District Judge Rob Junell, in Midland, Texas, ruled that customized compounds created by compounding pharmacies are not new, unapproved drugs that must be sanctioned by the U.S. Food and Drug Administration.

Kristie Zamrazil, a spokeswoman for the Texas Pharmacy Association, said the decision preserves the roots of pharmacy. "Compounding has been part of pharmacy practice since its origins. Judge Junell's ruling is a win for patients and recognizes the important health care service that pharmacists have provided through the ages" (Lavlan Copelin, Austin American-Statesman 5/27/06).

According to this ruling, "Compounded drugs are fully legal and not subject to the requirements and prohibitions imposed on new drugs by the 1938 Food, Drug and Cosmetic Act", AAPS General Counsel Andrew Schlafly stated.

“Domperidone has saved me. Until I started taking it, I was not able to function properly. I couldn’t find Domperidone anywhere in the U.S. It wasn’t available to be sold to me. Domperidone allowed me to feel alive again!” declared Bud Axelrod, of Philadelphia and living with Parkinson’s.

Additional information and links on the issue of Parkinson's, including Michael J Fox's Foundation for Parkinson’s Disease, the Parkinson’s Disease Foundation, the National Parkinson Foundation and the American College of Gastroenterology are available at http://www.lepharmacy.com/parkinson.asp.

LePharmacy.com is a premier mail order intermediary for brand name, highest quality health products, at great savings from typical U.S. prices. Prescriptions are required from a doctor’s visit. All prescriptions are individually reviewed and approved by licensed doctors and pharmacists and the drugs are all approved through the standards applied by the governments of Canada and the European Union.

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Jason Nishmas
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