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David Berkowitz, assistant director of the pharmacy at Newton-Wellesley Hospital, said he questions the validity of many drug expiration dates. That’s what happened in June, when the FDA posted extended expiration dates from Pfizer for batches of its injectable atropine, dextrose, epinephrine and sodium bicarbonate. The agency notice included the lot numbers of the batches being extended and added six months to a year to their expiration dates. At Newton-Wellesley, Berkowitz keeps a spreadsheet of every outdated drug he throws away. They ring up more sales when medications are tossed as “expired” by hospitals, retail pharmacies and consumers despite retaining their safety and effectiveness.
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- In the federal government’s stockpile, the expiration dates of both drugs have been extended, but they have to be thrown away by Berkowitz and other hospital pharmacists.
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For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates. In 1986, the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs’ expiration dates could be extended. In response, the FDA and Defense Department created the Shelf Life Extension Program. The federal agencies that stockpile drugs — including the military, the Centers for Disease Control and Prevention and the Department of Veterans Affairs — have long realized the savings in revisiting expiration dates.
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“I question the expiration dates on most of these drugs,” Berkowitz says. Citing the federal government’s extension program, the AMA sent letters to the FDA, the U.S. Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates.
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Though the drug is linked to Viagra in its end goal, and though both drugs are taken on an as-needed basis , the similarities stop there. “In men, Viagra fixes a ‘plumbing problem,’ if you will,” says Judith Volkar, MD, of the UPMC Magee-Womens Hospital in Pittsburgh. Viagra and other similar drugs treat erectile dysfunction, when a man can’t get or keep an erection that’s firm enough to have sex. On Friday, the Food and Drug Administration approved a new drug to treat a lack of female sexual desire. On Friday, the FDA approved Vyleesi to address problems with female sexual desire.