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Petition to Expand Coverage of a NEW Drug For Heart Patients
zheart posted:
I could also use the help of this community to please sign the petition that is linked below.

Recently, the FDA indicated it would not approve Vascepa for those on statin therapy with cholesterol levels from 200-500. The FDA rationale seems to be contrary to what our doctors are telling us that "lowering triglycerides does not produce fewer cardiovascular events". The FDA wants proof that lowering trigs reduces CVE events and requires results from an outcome study that is underway. The results of this study are expected in the next 4 years. In the meantime, the actions by the FDA limit drugs available to treat those like myself who suffer with atherosclerosis. These limits are in the form of prescription coverage our insurance company will allow. Right now I have Tier III coverage but these actions might cause my insurance company to drop coverage for my condition. Further, with all of the new regulations doctors do not have time to educate themselves on the latest treatments and drug companies actually perform a service when they can market to an indication. Don't let the FDA take away your ability to add a safe and effective drug to your treatment. The details about the drug and the misguided action of the FDA are contained in the petition.
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FDAYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

For more information, visit the Duke Health General and Consultative Heart Care Center