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An FDA monitory panel on Thursday voted 10-2 against recommending that Merck’s cholesterol drug Mevacor be granted over-the-chip status, the Philadelphia Inquirer reports. Although FDA is not doomed by its advisory panels’ recommendations, it usually follows them (Stark, Philadelphia Inquirer, 12/14). The decision marks the third time that an advisory panel has rejected such a request from Merck, the Face ruin Drive Chronicle reports. The panel said it is unclear whether consumers would use the drug correctly without guidance from their physicians (Wilde Mathews, Wall Street Tabloid, 12/14).

The panel was concerned by a study of 1,500 people that build about individual-quarter of them would take the pills self-possessed though they were not at a gamy adequate chance of nucleus disease to require the medication, needlessly exposing them to possible side effects, the AP/Long Island Newsday reports (Neergaard, AP/Long Holm Newsday, 12/13). Side effects for long-course use of statins count liver problems, muscle pain and weakness, according to the Newark Foremost-Ledger (Cohen, Newark Top-Ledger, 12/14). The study also found that 30% of tipsy-danger patients — who should be monitored by a physician — wanted nonprescription Mevacor. In summing-up, the proposed OTC Mevacor is less effective than some drug statins. More than half of patients taking statins said they would twitch to the weaker, nonprescription version if it were present, which could betray them to robustness risks.

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Merck argued that making a lower-dose statin available without a drug would help people with moderately high cholesterol control their brainwash. The dose maker also said that surrounded by high-risk patients who should be monitored, some are not under a physician’s meticulousness to start with, so OTC Mevacor would help them prevent verve attacks. “This is a real moment,” Edwin Hemwall, executive top dog of Merck’s worldwide OTC regulatory and scientific affairs, said. He added, “We are disappointed. We felt we presented a compelling case” (AP/Long Ait Newsday, 12/13).

Blow for Statin Manufacturers
The panel heard testimony from doctors and received letters from groups including the American Medical Association stating that consumers do not have the capacity to self-medicate with statins and that doing so could cause risks to their health. Physicians said that patients with high cholesterol need to undergo blood tests to monitor their levels and that they should visit a doctor every six months.

The decision is a “severe blow to a seven-year push by Merck and other drug makers to put statins, the world’s top-selling class of drugs, next to aspirin and other over-the-counter medications on retail pharmacy shelves,” the Chicago Tribune reports (Japsen, Chicago Tribune, 12/14). According to the Journal, the “10-2 vote leaves little hope Merck can win regulatory approval.” The decision also is a disappointment for GlaxoSmithKline, which bought rights to market the drug without a prescription in the U.S. (Wall Street Journal, 12/14). Some drug industry analysts said that making Mevacor nonprescription could increase sales to between $200 million and $300 million annually (Newark Star-Ledger, 12/14).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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