Weight-loss Drug Meridia Pulled Because of Increased Risk for Heart Attack and Stroke
Meridia has been withdrawn from the U.S. market because of an increased risk of heart attack and stroke according to the FDA. Abbott Laboratories voluntarily agreed to pull the drug after an FDA review of data that showed a 16 percent increased risk for heart attack, stroke, and death among people taking Meridia (sibutramine), compared with those taking a placebo.
In addition to the finding of an increased risk of heart attack and stroke, the review trial, called the Sibutramine Cardiovascular Outcomes Trial (SCOUT), found only a small difference in weight loss among those taking the drug and those receiving a placebo.
Meridia was approved in November 1997 for weight loss and maintenance of weight loss in obese people and in overweight people with other risks for heart disease. The approval was based on studies showing that about twice as many people taking Meridia lost at least 5 percent of their body weight compared with people taking a placebo who used diet and exercise alone to lose weight.
When approved, the FDA did have safety concerns because Meridia was known to increase both blood pressure and heart rate but believed at the time that the benefit of losing weight outweighed the risk of increased blood pressure and heart rate.
http://www.businessweek.com/lifestyle/content/healthday/644146.html?chan=rss_topStories_ssi_5
Drugmaker CEOs May Be Targets for FDA in Off-label Cases
Pharmaceutical executives whose companies promote unauthorized uses of their medicines may be targeted by the FDA for misdemeanor prosecutions. Pfizer struck the largest off-label promotion settlement to date in September 2009 agreeing to pay $2.3 billion for unauthorized marketing of its recalled painkiller Bextra and three other drugs.
The government may try to show more resolve to criminally charge individuals at all levels in the company to make progress in deterring off-label promotion. Executives would face as much as $100,000 fines and one year in jail. The FDA also can bar individuals from working in the drug industry.
http://www.bloomberg.com/news/2010-10-14/drugmaker-executives-may-become-targets-of-fda-for-off-label-promotions.html
FDA Warns of Thigh Fractures with Bone Drugs
Osteoporosis drugs used by millions of women to prevent bones from breaking may increase the chances for an unusual type of thigh fracture. The drugs include the bisphosphonates Fosamax, Boniva, Reclast, and Actonel. This could drive patients to Amgen Inc.'s just-launched rival medicine, Prolia, a different type of osteoporosis drug that is the company's most important future growth driver.
FDA officials said all bisphosphonates used for osteoporosis will carry a new warning about rare but serious fractures of the thigh bone, even though it remains unclear if the medicines caused the fractures. In 2009, there were more than 5 million U.S. filled prescriptions for bisphosphonates.
http://www.reuters.com/article/idUSTRE69C67N20101013
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