Questions about the Safety of Bisphosphonates - Quick Pulse

Summary: The FDA's Oncologic Drugs Advisory Committee (ODAC) met on March 4,2005, in Gaithersburg MD, to discuss safety concerns; specifically osteonecrosis of the jaw (ONJ); associated with two intravenous (IV) bisphosphonates from Novartis, Zometa (zoledronic acid) and Aredia (pamidronate disodium). Prior to 2001, only one or two cases a year of ONJ were reported by maxillofacial surgeons, but the number of cases has been increasing rapidly. The FDA acknowledged there have been reports of ONJ in osteoporosis patients on oral bisphosphonates, but the discussion at this panel meeting was limited to IV bisphosphonate use by cancer patients.

  Cox-2 Inhibitors and NSAIDs Safe Enough to Remain on the Market

Summary: Pfizers Bextra and Celebrex will remain on the market, but get a black box warning, if the FDA follows the advice of its advisory committee, which also determined that Mercks Vioxx is safe enough to return to the market, with an even stronger black box warning and other restrictions. However, the outlook for Cox-2 inhibitors still in development is doubtful. Panel members were very negative on the prospects for Novartiss Prexige, and Mercks Arcoxia likely would have to start another large (at least 20,000-patient) trial vs. Bayers Aleve (naproxen), which appears to be the new gold standard against which Cox-2s will be compared. Traditional non-selective NSAIDs also have become suspect, and the panel recommended they get warning labels as well.

  Tysabri Suddenly Pulled from Market - Quick Pulse

Summary: On Monday, February 28, 2005, Biogen Idec and Elan made a surprise announcement that they were taking their new multiple sclerosis (MS) drug, Tysabri (natalizumab, antegren), off the market just three months after it was launched. This report reviews what is known so far about the problem with Tysabri, based on comments by officials of both companies as well as interviews with FDA officials, neurologists who treat MS, patients, consumer groups, and media sources. The bottom line is that Tysabri is unlikely to return to the market soon, despite company predictions that it will, and when and if it does, it is likely to have a black box warning, be restricted to rapidly-deteriorating interferon-failures, and/or have a time limit on use. Patients are still anxious for the drug and willing to take some risk, and neurologists also would like to see Tysabri available, but the regulatory hurdles appear high.