Product news from the 04/03/07 news brief

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The FDA approved Merck combination pill Janumet, for type 2 diabetes. The drug contains Merck’s sitagliptin—the active ingredient in Januvia—and an older glucose-lowering agent called metformin. Januvia, part of a class of drugs called DPP-4 inhibitors, was approved in October. It enhances the body’s own ability to lower blood sugar levels. Novartis is seeking FDA approval for its own DPP-4 inhibitor, Galvus, but an FDA request for more data has delayed launch. The FDA and Sanofi-Aventis have notified healthcare professionals of revisions to the prescribing information, including a boxed and a new patient medication guide, for the antibiotic Ketek. Two of the three previously approved indications, acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, were removed from the prescribing information because the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances. The boxed warning states that Ketek is contraindicated in patients with myasthenia gravis. The Patient Medication Guide, which must be distributed to all patients, informs them about the risks of the drug and how to use it safely. The FDA has licensed Baxter Healthcare’s Ceprotin, the first biologic treatment for patients with a rare genetic defect that can cause a potentially life-threatening clotting disorder. Ceprotin is made from the plasma of healthy human blood donors. It is a concentrated form of protein C, a substance normally manufactured in the liver that circulates in the plasma in very small amounts. Protein C plays an important role in controlling blood coagulation by preventing the formation and growth of blood clots. Severe congenital protein C deficiency is a rare genetic defect found in one to two newborns for every million births. Patients with insufficient levels of protein C experience abnormally high numbers of blood clots. Complete absence of the protein is fatal. Symptoms typically appear soon after birth. Clotting may occur in the blood vessels of the skin, eyes, brain, kidneys and throughout the body. Patients with severe inherited protein C deficiency must take oral or injected anticoagulant drugs on a regular basis to avoid blood clots. Ceprotin is intended to treat these patients when they are faced with a life-threatening situation from blood clots in the veins, or a severe skin and systemic blood clotting disorder known as purpura fulminans. The FDA granted Ceprotin orphan drug status, which provides the manufacturer with financial incentives to develop a drug or biologic to treat a rare disease (affecting fewer than 200,000 people in the US). Since 1983, more than 200 drugs and biological products have been brought to market in this way. FDA reviewed the drug’s Biologics License Application under a priority review schedule. Manufacturers of the Parkinson’s drug pergolide have decided to voluntarily withdraw their products from the US market because of potential damage to patients' heart valves. The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals and two generic pergolide versions manufactured by Par Pharmaceutical and Teva Pharmaceutical Industries. Pergolide is in a class of drugs called dopamine agonists and is used with levodopa and carbidopa medications to manage tremors and slowness of movement in Parkinson’s disease patients. In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the US. Permax was first approved in 1988 for Eli Lilly as an adjunctive therapy with levodopa in Parkinson’s disease patients. In 2003, the FDA asked for valvulopathy (abnormality of cardiac valves) to be added to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was issued by Lilly. In 2006, the warning was upgraded to a “black box” status, due to new data concerning risks of heart valve damage. Two recent New England Journal of Medicine studies confirmed previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid and aortic valves of the heart, the FDA said. The agency said its is working with pergolide manufacturers to see if it remains possible to make the drug available under an Investigational New Drug Application for those few patients receiving pergolide and who cannot be successfully converted to other available treatments.

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