Product News and Recalls

GlaxoSmithKline paying record settlement for fraud

GlaxoSmithKline has agreed to pay $3 billion in fines for fraudulently promoting medications for unapproved uses. According to a New York Times report, it’s the largest settlement ever leveled against a pharmaceutical company.

But the settlement doesn’t end the company’s legal disputes. Widespread lawsuits allege that GlaxoSmithKline and other manufacturers of antidepressants classified as selective serotonin reuptake inhibitors failed to adequately warn pregnant patients of studies linking the drugs to potentially dangerous heart and lung defects in newborns.

Other SSRI antidepressants include Prozac and Zoloft.

Prosecutors claim GlaxoSmithKline employed several tactics aimed at encouraging doctors to prescribe anti-depressants to children, including helping to publish a medical journal article that misreported data from a clinical trial. A warning was later added to the drugs that they might increase the risk of suicidal thoughts in teenagers.

The company allegedly marketed its antidepressant Wellbutrin for conditions like weight loss and sexual dysfunction when it was approved only to treat major depressive disorder.

According to federal prosecutors, GlaxoSmithKline also courted doctors by paying for trips to Jamaica and Bermuda, spa treatments and hunting excursions.

The three criminal charges involved Wellbutrin and Avandia and included a criminal fine of $1 billion. The remaining $2 billion involves fines in connection with a civil settlement over the sales and marketing practices of the blockbuster asthma drug Advair and several other drugs.

Part of the civil settlement includes claims that the company overcharged the government for drugs.

Three criminal charges included a fine of $1 billion, and involved Wellbutrin and diabetes drug Avandia. Federal prosecutors said the company had failed to report data from studies detailing Avandia’s heart safety risks to the U.S. Food and Drug Administration.

The remaining $2 billion is from fines in connection with a civil settlement over the sales and marketing practices of the asthma drug Advair and several other drugs.

Patients should consult their doctors before making any changes in their medication. A consultation with an SSRI lawyer is also important if there are significant injuries from SSRIs.

See the story here:

http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=1&_r=1