Federal regulators are requiring Bayer Healthcare to revise its marketing materials for Yaz and Yasmin to reflect new safety information that was recently added to the drugs’ labels. In a letter to Bayer dated April 7, the Food & Drug Administration (FDA) said revisions must include “prominent disclosure of the…
New safety information regarding the risk of blood clots has been added to the labels of Yaz and Yasmin, Bayer Healthcare’s popular birth control pills. The label update comes as Bayer faces at least 1,100 lawsuits filed by women who claim to have been injured by either Yaz or Yasmin.…
NuvaRing, a contraceptive device marketed by Organon Pharmaceuticals and Merck & Co., has been named in some 300 product liability lawsuits. The lawsuits claim that NuvaRing caused plaintiffs to suffer serious, life-threatening blood clots. NuvaRing is a transparent, flexible vaginal ring that provides month-long birth control by emitting a continuous…
A federal appellate court has upheld a lower court ruling dismissing the first product liability lawsuit among thousands alleging British drugmaker AstraZeneca PLC’s antipsychotic drug Seroquel triggered a patient’s diabetes. A three-judge panel of the 11th Circuit Court of Appeals ruled that the U.S. District Court for the Middle District…
The families of two north Mississippi girls killed in a 2008 accident have filed a wrongful death lawsuit against the maker of an all-terrain vehicle. Melissa and Richard Lee Bates and Aundria and Thomas Dilworth filed the suit in Gwinnett County, Ga., against Yamaha Motor Corp. and Yamaha Motor Manufacturing…
For 14 years until just last month, GlaxoSmithKline sold a denture cream called Super Poligrip that contained high levels of zinc. The zinc helped with adhesion and was probably safe so long as people used moderate amounts of cream. Indeed, the human body needs small amounts of zinc to function.…
The American Journal of Gastroenterology, in a study published on March 30, 2010 stated that the use of isotretinoin, Accutane, was linked to the development of ulcerative colitis. The study included 8,189 patients with inflammatory bowel disease (IBD) and 21,832 controls. Of the patients with IBD, which includes Crohn’s disease…
Bayer AG, Germany’s largest drugmaker, was accused in a lawsuit of ignoring health risks of the contraceptive Yaz and advertising the drug as safe to boost sales. The Yasmin family of birth-control pills, known as Yaz and Yasmin, carries a four times increased risk of deep vein thrombosis and pulmonary…
Another lawsuit has been filed against Bayer by a California woman who suffered gallbladder disease after using Yasmin, alleging that the drug maker knew the birth control pill carried unacceptable health risk but released it any way. The Yasmin gallbladder lawsuit was filed in San Mateo County Superior Court by…
AstraZeneca Plc officials properly warned a patient’s doctors about the diabetes risk posed by its Seroquel antipsychotic drug, a jury ruled in the first case over the medicine to go to trial. The state court panel in New Brunswick, New Jersey, deliberated before finding the company’s warnings to Ted Baker’s…