Dangerous Drugs - Avandia, Welllbutrin, Zyban, Yaz, Digitek, Fosamax


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Pharmaceutical Cases
	Latest News on Lawsuits Involving Injuries from Dangerous Drugs
	Avandia
	A medical reviewer for the FDA concluded that GlaxoSmithKline, the manufacturer of Avandia, misinterpreted critical details of a study aimed at assessing the risks of the drug. The reviewer indicated that the study confirmed cardiovascular risks associated with Avandia. The FDA review concluded that GlaxoSmithKline's misreadings of the study were so profound that they "suggest serious flaws with trial conduct."
	Wellbutrin & Zyban
	A recent article published in American Journal of Obstetrics & Gynecology identified a positive association between early pregnancy use of Wellbutrin or Zyban and heart defects in the mother's offspring.
	Levaquin
	The FDA now requires the manufacturer of Levaquin to include a black box warning to alert patients to the risk of tendon ruptures. A black box warning is the strongest warning available to the FDA to inform patients of a drug's risks. Between November 1997 and December 2007, the FDA received more than 400 reports of tendon rupture following use of fluoroquinolones, including Levaquin.
	Yaz Warning
	An array of side effects have been associated with the use of Yaz, Yasmin and Ocella. These include pulmonary embolism, deep vein thromobsis, heart attack and stroke. All oral contraceptives produce an increased risk to women of abnormal blood clots, but Yaz, Yasmin and Ocella present higher risks than do other birth control pills on the market.
	Digitek Recall
	April 25, 2008—Actavis Towtowa announced a Digitek recall as a result of a manufacturing defect that resulted in production of the pills at twice the approved level of Digoxin. The FDA has designated the recall as Class 1, indicating the risk involves serious health problems or death.
	Fosamax Lawsuit
	April 10, 2006—A Florida woman filed a lawsuit against Merck, the manufacturer of Fosamax, alleging the drug caused her to develop osteonecrosis. The condition caused her mouth to rot and exposed bone in her jaw. Various reports link Fosamax with the serious bone condition. In fact, the FDA believes Fosamax should be accompanied by a warning alerting physicians and patients to the risk of osteonecrosis. Because the agency lacks the power to force labeling changes, as of May 2006 Merck still had not updated the label for Fosamax.