Bayer Sued, Accused of Hiding Yaz Risk to Boost Sales

Mike Kelly — Fri, 09 Oct 2009 09:36:16 GMT

Oct. 6 (Bloomberg) -- Bayer AG, Germany’s largest drugmaker, was sued by two Pennsylvania pension funds and accused of misrepresenting the safety and effectiveness of the Yaz contraceptive to boost sales.

Bayer unlawfully promoted the drug from March 2006 to March 2009 by concealing side effects including blood clots, heart attacks and pulmonary embolisms, two health and welfare funds for firefighters and city employees said in a federal court complaint made public today in Philadelphia.

The Yasmin family of birth control pills, known as Yaz, Yasmin and Yasminelle, were Bayer’s top-selling drugs last year, bringing in about $1.8 billion, a 17 percent increase over 2007.

About 300 cases have been filed against the company over Yaz. Roughly 200 have been filed in federal litigation consolidated in East St. Louis, Illinois. Another 50 have been consolidated in state court in Philadelphia.

Women who took the drug to prevent pregnancy or treat premenstrual disorder or acne may have suffered side effects including strokes, heart attacks, gallbladder disease and sudden death, according to the complaints.

Marcy Funk, a spokeswoman for Bayer, declined to comment on the pension funds’ lawsuit.

“We’re not aware of 300 cases’ being served,” Funk said today in a phone interview. “As of Sept. 24, Bayer has been served in 74 cases.”

Swiss Probe

Bayer announced Sept. 25 that Yaz is part of a Swiss health regulator’s investigation into the death of a woman who took the pill. The Swissmedic agency and an investigative judge are looking into the case of the woman, who died from a pulmonary embolism, or blockage of an artery in the lung.

The funds’ complaint was filed by the Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund and the American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund.

Yasmin, which inhibits ovulation, is made with the active ingredient drospirenone. Several studies indicate that the compound causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia, according to the complaint.

Yaz and Yasmin are the only contraceptives to contain drospirenone, the complaint said. Hyperkalemia can disrupt normal heart rhythms and cause blood clots to form that can lead to heart attacks, pulmonary embolisms and strokes, lawyers for the funds said in the filing.

TV Commercials

Bayer concealed and minimized the risks associated Yaz when promoting the drug, the plaintiffs said. Television commercials “misleadingly and deceptively” promoted the drug for uses not approved by regulators, the complaint said.

In February, Bayer Corp., a unit of Leverkusen, Germany- based Bayer, announced it would spend $20 million for “corrective advertising” as part of a 27-state settlement of claims it misled consumers about Yaz.

The accord resolved complaints that Bayer promoted the drug as an acne treatment and other conditions for which its use hadn’t been approved by the U.S. Food and Drug Administration.

The case is Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund v. Bayer Healthcare Pharmaceuticals Inc., 2:09-cv-04567, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).

To contact the reporter on this story: Sophia Pearson in Wilmington, Delaware, at spearson3@bloomberg.net.

~From Bloomberg.com, October 9, 2009

Originally posted at InjuryBoard by Mike Kelly

FDA Releases Findings on ADHD Medications, Potential Link to Sudden Death in Healthy Children

Will Parker — Tue, 16 Jun 2009 10:03:03 GMT

The FDA recently notified healthcare professionals that it is providing its perspective on data published in the American Journal of Psychiatry concerning the potential risks of stimulant medications used to treat children suffering from Attention-Deficit/Hyperactivity Disorder (ADHD). This study, which was funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in motor vehicle accidents. The study's authors concluded that there could be an association between the use of stimulant medications and sudden death in healthy children.

Considering the limitations of this study's methodology, the FDA was unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. Accordingly, the FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. However, parents should discuss concerns about the use of these medicines with their child's treating physician. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

The following medications were included in the study: Focalin, Focalin XR (dexmethylphenidate HCl); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

More information is available at the FDA's web site: http://www.fda.gov.

Originally posted at InjuryBoard by Will Parker

Florence-Myrtle Beach Personal Injury Lawyer - FDA & Prescription Drugs

Bayer Sued, Accused of Hiding Yaz Risk to Boost Sales

FDA Releases Findings on ADHD Medications, Potential Link to Sudden Death in Healthy Children