Court Reverses $3M Award Over Antidepressant Label

CHICAGO (CN) – GlaxoSmithKline cannot be held responsible for failing to warn older adults of the suicide risk attached to its antidepressant drug Paxil because the government refused to allow the drugmaker to add such a warning, the Seventh Circuit ruled.

In 2010, Stewart Dolin, 57, took his own life by stepping in front of a train in downtown Chicago.

At the time, he was taking the generic form of paroxetine, a drug to treat depression and anxiety, which is linked to suicidal behavior.

GlaxoSmithKline makes the brand-name version of the drug, Paxil. Both the brand-name and generic forms of paroxetine carry the same label warning that it is associated with suicide in patients under age 24. However, the label does not warn about any association between the drug and increased risk of suicide in older adults.

Last year, a jury awarded Dolin’s widow $3 million after finding GSK responsible for not warning patients over age 24 of the risk of suicidal behavior.

Even though Dolin did not ingest any product made by GSK, the jury found that he was harmed by an incomplete label, which under federal law only GSK could change.

But the Seventh Circuit reversed the award Wednesday because the U.S. Food and Drug Administration rejected GSK’s multiple attempts to add just such a warning.

“GSK has provided undisputed evidence that the FDA rejected any adult‐suicidality warning in 2007 when the agency required all SSRIs [selective serotonin reuptake inhibitors] to adopt the same class-wide warnings,” U.S. Circuit Judge David Hamilton said, writing for a three-judge panel.

“Dolin’s state‐law claim against GSK is preempted if GSK could not have added the adult‐suicidality warning using the CBE [changes being effected] regulation,” which is a regulation that allows label changes without prior FDA approval, the judge added.

In 2006, GSK acted on its own to change paroxetine labeling and sent a letter to doctors nationwide saying that the suicide risks of the drug may extend beyond the age of 24.

The FDA’s independent analysis of all SSRIs in 2007 found a statistically significant 2.76-fold increase in suicidal behavior in adults, but concluded that the net effect of the antidepressant drugs on adults diagnosed with depression “appears to be neutral.”

At the same time, the agency required that all antidepressant labels be uniform and warn only of the suicide risk in patients age 24 or younger, so it effectively rejected GSK’s attempt to change the paroxetine label to warn of the potential danger to adults.

After this decision, GSK repeatedly asked the FDA for permission to add a paroxetine-specific suicide warning, but the FDA refused.

And since 2010, GSK has not acquired any new information that would have allowed it to add the same warning it sought to add in 2006, the Seventh Circuit found.

“GSK asked the FDA for permission to modify the paroxetine label as plaintiff argues was need. The FDA has said no, repeatedly,” Hamilton wrote. “Federal law thus preempted plaintiff’s Illinois law claim that GSK should have warned of a risk of adult suicidiality on the paroxetine label in 2010.”

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