In the wake of last week’s Supreme Court decision that protected the rights of patients to sue drug makers for liability in state courts, two lawsuits are receiving particular attention. Bloomberg News reports that Pfizer and a GlaxoSmithKline PLC unit are being blamed for not warning that their antidepressants—Zoloft and Paxil—might provoke suicidal ideation and suicide in adults.
The two justices ordered the U.S. Court of Appeals for the Third Circuit in Philadelphia—which previously rejected the suits—to reconsider following the recent Supreme Court decision allowing such suits to be tried in state courts. The suits were filed by the family of a woman who committed suicide after taking Glaxo’s Paxil and a man who committed suicide after taking Pfizer’s Zoloft, said Bloomberg; both suits are among hundreds filed against drug makers. The justices also asked for reconsideration of a prior rejection of a false advertising suit involving AstraZeneca PLC’s Nexium anti-ulcer drug.
In 2005, for the first time, the Food & Drug Administration (FDA) required antidepressant package warnings aimed at doctors and patients regarding suicide risks in children; in 2007, the warning was broadened to include people ages 18 to 24, said Bloomberg. In 2006, the FDA proposed expanding the labels of all antidepressants to include a warning of suicidal thoughts in patients ranging from 18-24 years of age and a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment. In 2006, Glaxo and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too, and changed the drug’s label to reflect that risk.
The FDA has urged the makers of Zoloft and other SSRI (selective serotonin reuptake inhibitors) antidepressants to add a warning about suicidal behavior and has said that patients using Zoloft and other antidepressants should be watched closely for suicidal tendencies. The expanded warnings on antidepressant labels advise health-care providers to “carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either decreases or increases.”
Suicide is the fourth leading cause of death for those aged 18 to 65 and the third leading cause for those aged 15 to 24 in the United States. Add to those figures the complexity of medications. In recent years, disturbing reports have suggested that side effects of some popular drugs—Chantix, Accutane, Singulair, Zoloft, and Paxil—include suicidal thoughts and behavior.
Reports have been filed with drug makers and the FDA on at least six drugs or drug classes that may be linked to suicide or suicidal ideation and the FDA released notices last year about several such medications including Singlulair; epilepsy drugs including carbamazepine, gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, and valproate; and the smoking-cessation drug Chantix. Reports have been filed on SSRI antidepressants including Paxil and Prozac, the influenza drug Tamiflu, and the acne medicine Accutane. “The brain is a complex organ, and most of the drugs are complex as well,’’ said Dr. Thomas Laughren, head of the division of psychiatric products at the FDA, in a report last year. “It’s not unreasonable to think that a drug that gets into the brain may have effects other than you hope they would.’’