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Author Topic: CALL TO ACTION -- Requested FDA action for low HDL from protease drugs  (Read 4146 times)

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Offline ZCorker

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Most recently I contacted the FDA postmarketing group to demand that the FDA take action against all manufacturers of protease for not offering treatment to counter the low HDL and high c-reactive protein caused from the protease drugs.  The FDA postmarketing website is located at http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm and a contact e-mail on this site for future followup is <pmcweb@cder.fda.gov>.

   Protease significantly reduces the amount of Blood Serum Adiponectin in the blood stream and the loss of this hormone is associated with the sunken face syndrome, low HDL, cardiology problems, increased risk of cancer, increased risk of diabetes, and low bone density.  Possible treatments are Pioglitazone, but Pioglitazone is not approved for this problem and is only approved blood sugar over 120.  In addition, there is no standardized test for blood serum adiponectin.

   Lilly/Takeda, the manufacturers of this drug are conducting a widescape study for treatment of peripheral artery disease, but hiv patients are excluded in most situations and in some rare cases will be allowed in the study if they have very advanced disease.

   Going after the makers of protease drugs for offering treatments to repair the damage from the drugs is a reasonable thing to ask for.  I encourage everyone to contact the FDA and post any response from the FDA on the matter as well as other followup.



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