HIV sufferers benefit from the FDA’s unapproved drugs initiative

by Gary Puckrein, PhD

Unapproved drugs have never been tested by the Food and Drugs Administration for safety and efficacy. Prescribed by the million every year in the United States, these products pose a potential danger to all patients, but HIV/AIDS patients who suffer weakened immune systems are at an even higher risk as they are more vulnerable to injury due to their disease.

That’s why we at the National Minority Quality Forum (NMQF) were alarmed by a recent FDA new label information release revealing that HIV/AIDS patients have been unnecessarily exposed to unapproved drugs, specifically untested colchicine medications used to treat gout, a disease which often affects HIV/AIDS patients. Untested colchicine medication for the treatment of gout is unnecessary due to the fact that an approved colchicine product is available, and should be removed from the market by the FDA.

“Colcrys,” the approved product, passed through the FDA’s rigorous approval process which weeds out potentially dangerous or ineffective drugs from those that are fit for the public’s use. During that process, valuable new information regarding colchicine, a highly toxic drug, was discovered, including dosing recommendations for colchicine when prescribed for the treatment of Familial Mediterranean fever, the prophylaxis of gout, and gout. It was also determined that colchicine should not be co-administered with protease inhibitors for HIV patients with hepatic or renal impairment. This information was included in the FDA’s release to educate patient and patient advocates on this new information discovered in clinical trials and research done because of FDA’s Unapproved Drug Initiative.

Unapproved drugs often lack accurate ingredient information and warning labels meant to help patients avoid dangerous drug to drug interactions. According to the FDA’s own Marketed Unapproved Drug Compliance Policy Guide, it’s estimated that there are several thousand different unapproved drugs currently on the market prescribed to patients every year.

Most HIV/AIDS patients have enough medical concerns without having to worry about being prescribed an unproven medication. We encourage the entire health care community to help protect HIV/AIDS patients from unapproved drugs. Doctors must be sure that the drugs they are prescribing have been through the FDA’s rigorous testing process.

Pharmacists are the next line of defense and should make sure they only dispense approved products to patients whenever possible. And, most importantly, everyone should contact the FDA in order to let them know that it is time for them to do a better job of protecting American patients by enforcing their “Unapproved Drugs Initiative,” which calls for the removal of unapproved drugs from the marketplace.

Editor’s note: Since this blog was written, the Food and Drug Administration has taken action to remove unapproved single-ingredient oral-colchicine products from the American drug-market. The National Minority Quality Forum (NMQF) released a statement from NMQF President and CEO Gary Puckrein applauding the FDA for “steps they’ve taken to protect patients by directing the removal of unapproved colchicine products from the market,” and reminding “drug stores, pharmacy chains, and distribution lines to follow the FDA’s directive and act in the best interest of patients by taking unapproved colchicines off store shelves.”

Gary Puckrein is President and CEO of the National Minority Quality Forum.  The Did You Know Project (DYKP) is an educational project of the Forum.

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