        |
    Voluntary suspension of sales and marketing for Palladone® July 15, 2005 - The FDA has issued a public health advisory to notify health care professionals and consumers that the sponsor of Palladone®, Purdue Pharma, has agreed to suspend sales and marketing of Palladone® (hydromorphone hydrochloride, extended release capsules), a potent narcotic painkiller, because of the potential for severe side effects if Palladone® is taken with alcohol. Drinking alcohol while taking Palladone® may cause rapid release of hydromorphone, leading to high drug levels in the body, with potentially fatal effects. High drug levels of hydromorphone may depress or stop breathing, cause coma, and may even cause death. Patients being treated with Palladone® should contact their physician to discuss appropriate alternative treatments. Purdue Pharma completed a study in 24 healthy men that showed that, compared to taking Palladone® by itself, concentrations of hydromorphone in the blood were 5.5 times higher when the 12 mg Palladone® extended release capsules (the lowest dose available) were taken with 8 ounces of 40% alcohol. Lower concentrations of alcohol showed fewer, but still potentially serious effects on the release of hydromorphone from Palladone® in some individuals. Studies showed that taking Palladone® with a mixed drink (equivalent to 20% alcohol) or beer (equivalent to 4% alcohol) increased hydromorphone concentrations 1.9 and 1.03 times higher, respectively, compared to taking Palladone® by itself. Patients who, on the advice of their physician, continue to take their current supply of Palladone® should not drink alcohol, including beer, wine or distilled spirits, or take other prescription or over-the-counter-medications that contain alcohol on days they take Palladone®. Until further notice, all claims submitted for Palladone® will reject for prior authorization required. Pharmacists at the point of service may call the RxAmerica Customer Service Desk for information on the suspension of this product and for an override to allow the claim to pay, once informed. RxAmerica believes in providing excellent customer service and ensuring the health of all its members. As always, pharmacies and members can contact the RxAmerica Customer Service Desk at 1-800-770-8014 if they have any questions about this voluntary drug suspension. |
     |