Pfizer stands by Chantix
NEW YORK — Pfizer defended a drug used for smoking cessation Monday following reports of a Canadian study that found it raised the risk of heart problems.
The 8,216-patient study of Chantix (varenicline), published in the Canadian Medical Association Journal, found that of the 4,908 patients who received Chantix, 52 had an increased risk of serious heart problems, with similar risks appearing in 27-of-the-3,308 patients who took placebo.
Pfizer responded by pointing out that the authors of the study said the cardiovascular risk “estimates are imprecise owing to the low event rates.”
“Pfizer scientists and doctors continuously evaluate the benefits and risks of its medicines, including Chantix,” Pfizer VP medical affairs Gail Cawkwell said. “The currently available safety data on Chantix, including a pooled analysis of clinical data in 7,375 people trying to quit smoking, do not support an increased cardiovascular risk associated with Chantix.”
Still, the study’s findings won’t do the drug any favors. In 2008, the Federal Aviation Administration banned its use by pilots and air-traffic controllers after it was found to increase the risk of depression and suicidal thoughts and behaviors, and the Food and Drug Administration ordered that it carry a boxed warning, the strongest possible safety label, in 2009.
Par to restructure branded business
WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.
The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.
"To achieve our goal of optimizing Strativa’s potential, we found it necessary to reduce the number of sales representatives and focus on Megace ES and Nascobal at this time," Par chairman, president and CEO Patrick LePore said. "We remain fully committed to the branded business and believe it is a valuable platform for future growth."
Xarelto OKed by FDA
RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.
Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.
“The approval of once-daily Xarelto tablets will provide a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery,” Harbor-UCLA Medical Center professor of orthopedic surgery Louis Kwong said on behalf of J&J. “Xarelto has a proven clinical benefit over one of today’s most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice.”