Breaking News

October 11, 2004

Zometa linked to osteonecrosis of the jaw

Zometa linked to osteonecrosis of the jaw The FDA and Novartis recently notified healthcare professionals of revisions to the Precautions and Adverse Reactions sections of the labeling for zoledronic acid (Zometa) and pamidronate sodium (Aredia) that describe spontaneous reports of osteonecrosis of the jaw, mainly in cancer patients who have received bisphosphonates as a component of their therapy. A dental examination with appropriate preventive dentistry should be considered prior to bisphosphonate therapy in those with concomitant risk factors, such as cancer, chemotherapy, corticosteroid use, and poor oral hygiene. The MedWatch 2004 safety summary, including links to the "Dear Healthcare Professional" letter, is available at: http://www.fda. gov/medwatch/SAFETY/2004/safety04.htm#zometa..

Merck announces global withdrawal of Vioxx Citing safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) following chronic use, Merck has voluntarily withdrawn rofecoxib (Vioxx) from U.S. and worldwide markets. Patients currently taking rofecoxib should contact their physicians to discuss discontinuing their use of the medication and possible alternative treatments. The FDA said it will closely monitor other drugs in this class for similar side effects. Additional information may be obtained from http://www.merck.com/ and http://www.vioxx.com/, or by calling (888) 368-4699.

Enbrel gains three FDA approvals The FDA has issued three approvals for Amgen and Wyeth's biologic product etanercept (Enbrel). A new 50-mg/ml prefilled syringe has been approved as the recommended dosing form for treatment in all approved adult indications. The new formulation will eliminate the need to mix the drug prior to injecting, while allowing most patients to take only one injection per week instead of the two 25-mg injections currently used by patients. The 25-mg formulation will remain available for juvenile rheumatoid arthritis patients and for those who prefer the twice-weekly method. Etanercept also becomes the first biologic approved for the induction of a major clinical response in patients with RA. In addition, the etanercept labeling will include updated radiographic data, which demonstrated that more than half of etanercept patients observed in an open-label, long-term study experienced no progression of joint damage for up to five years.

FDA clears extended-release hydromorphone Palladone (hydromophone HCl extended-release) capsules have been approved for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid pain relief for an extended period of time. The extended-release capsules, which offer once-daily dosing, will be available in 12-, 16-, 24-, and 32-mg dosage strengths. Based on the risks associated with the drug, the company and the FDA agreed upon a comprehensive risk management program (RMP) to facilitate proper patient selection, reduce accidental pediatric exposure, and minimize abuse or diversion of the product. Purdue expects to have Palladone capsules available in pharmacies in the first half of 2005.