Drug Topics - February 25, 2008 - (Page 9)

9 NEWS Roundup be concerned. Following review of the reports, it seems increasingly likely that the abnormal behavior — changes in mood, agitation, depression, and suicidal ideation — is due to exposure to the drug and not to other causes. So said FDA’s director of the Division of Anesthesia, Analgesia, and Rheumatoid Products, Bob Rappaport, M.D. As a result of the findings, the FDA has asked Pfizer to increase the prominence of the potential serious neuropsychiatric symptoms in the warnings and precautions section of the product’s prescribing information. The company will also finalize an official Medication Guide for distribution to patients. Patients should let their healthcare providers know if they have a history of psychiatric illness prior to taking the drug; healthcare professionals should monitor for changes in a patient’s mood and behavior during treatment and report immediately to their provider if they occur, according to FDA. Varenicline was approved in 2006 as an aid to smoking cessation. New label approved to reflect Thrombin-JMI manufacturing changes New labeling for King Pharmaceuticals’ Thrombin-JMI, a topical bovine thrombin, states that the manufacturing process is capable of removing significant amounts of extraneous proteins, resulting in a reduction of Factor Va light chain content below the limit of detection. Some studies have proposed that the presence of bovine Factor V in bovine thrombin could elicit the formation of antibodies that cross react with human Factor V and potentially lead to bleeding. Thrombin-JMI is indicated as a hemostat for fast, topical control of surgical bleeding. Government and Law Members of 340B program to get windfall from Merck settlement Hospitals and other health entities in the 340B drug discount program will be collecting more than $8 million in refunds as a result of a $650 million settlement that Merck has agreed to pay state and federal authorities. The settlement follows qui tam suits brought by two whistleblowers who charged that the drug firm underpaid rebates to Medicaid and illegally remunerated health providers to induce them to prescribe the company’s products. According to the justice department, this is one of the largest healthcare fraud settlements it has ever logged. For its part, Merck said the settlement does not constitute an admission of guilt. Medtronic gets nod for drug-eluting stent The Food & Drug Administration has granted approval to Medtronic’s zotarolimus-eluting stent for treating patients with narrowed coronary arteries. According to the agency, clinical trial results showed the drug-eluting stent (DES) had an associated stent thrombosis rate of 0.4% at one year and 0.5% at two years post-implant. Endeavor is the first DES approved since the FDA convened a panel to discuss the risk of thrombosis associated with DES placement. Patients receiving the Endeavor stent will need to be anticoagulated for at least six months after implantation and should consider continuing this regimen for 12 months if they are not at an increased risk for bleeding complications. A stent is a tiny wire tube used to Medtronic will conduct a meshopen a coronary prop post-approval five-year artery after it has been 5,000-patient study to evalu- cleared of a blockage ate long-term safety and effi- in a minimally invasive procedure called balcacy, and to identify the op- loon angioplasty. The timal duration of dual balloon is inflated to antiplatelet therapy follow- compress the plaque against the wall of the ing percutaneous interven- artery and to expand the stent. tion with the new stent. Conmen sentenced for Medicaid fraud Two individuals who had helped Alexander and Valentina Milman, secret owners of Lakeshore Pharmacy in Kirkland, Wash., defraud Medicaid have been sentenced. Oleg Ordinartsev, who had submitted false paperwork to Medicaid to hide Milman’s ownership, was sentenced to a year and a day in prison. Vladimir Mitkovetski, who had lied to investigators, claiming he was the owner of Lakeshore, was put on two years’ probation. These sentences follow Alexander Milman’s sentence of 63 months in prison and more than $1 million in restitution issued last November. The fourth defendant, Valentina, is expected to be sentenced next month. The Milmans were charged with using false records to bill Medicaid for drugs and medical supplies that were never delivered to patients. DT Illustration: Medtronic Answer to Rx Puzzler The answer to the Rx Puzzler on page 4 is Cipro (ciprofloxacin HCl, Bayer Corp.)

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Drug Topics - February 25, 2008

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