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 important new safety information.”
Bayer announced that it was updating the “Warning” sections of the Yaz and Yasmin labels to include additional information about the risk of blood clots associated with the birth control pills. The new information is based on two large, multiyear studies of more than 120,000 women taking contraceptives in the U.S. and the U.K., Bayer said.
Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.
Articles Posted in Product Liability
Yaz, Yasmin Label Updated to Included Information on Blood Clots
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.
Yaz and Yasmin are both made with a type of progestin called drospirenone, making them different from many other oral contraceptives.
NuvaRing Named in 300 Product Liability Lawsuits
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 dose of estrogen and progestin for 21 days. The device releases a combination of ethinyl estradiol, a form of the hormone estrogen, and etonogestral. Nuvaring is marketed as providing the same efficacy as birth control pills but more convenient by offering month-long protection.
Appeals Court Upholds Dismissal of Lawsuit Alleging Seroquel Caused Diabetes
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 of Florida had correctly dismissed the case brought by Linda Guinn, a former legal secretary from Palm Bay, Fla., in her early 60s.
Miss. Families File Wrongful Death Lawsuits of Girls on Rhino ATV
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 Corp. of America.
The lawsuit claims multiple design and engineering flaws contributed to the deaths of the two 11-year-old girls.
Poligrip and Fixodent Litigation Update
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. But some people ended up using much larger amounts, and they began to develop the kind of nerve damage associated with excess zinc.
New Study Finds That Isotretinoin, Accutane Use Linked To Ulcerative Colitis
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 and ulcerative colitis, 3,664 had Crohn’s disease, 4,428 had ulcerative colitis and 97 had an unspecified IBD condition. Sixty study participants were exposed to isotretinoin.
Read the article here at the American Journal Of Gastroenterology.
Bayer Accused in Canadian Lawsuit of Hiding Yaz Risks
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 embolism compared with other contraceptives, according to the suit, filed in St. Catharines, Ontario, by two women. They seek class-action, or group, status to represent all women who used the drugs.
Yasmin Gallbladder Disease Lawsuit Filed Against Bayer
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 Louise Thanos.
The case is one of about 1,100 Yaz and Yasmin lawsuits filed on behalf of individual women who allege that they suffered injuries as a side effect of the birth control pills. In addition to lawsuits for gallbladder problems, cases have been filed by women who allege the pills caused them to suffer blood-clot related injuries, such as a stroke, heart attack, pulmonary embolism or deep vein thrombosis.
AstraZeneca Wins Trial on Seroquel Diabetes Claim
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 doctors absolved AstraZeneca of responsibility for his injuries. Baker, 61, took Seroquel for lingering effects of post-traumatic stress syndrome caused by his military service in Vietnam. His was the first of about 26,000 claims over the drug to be considered by jurors.