What Is A Black Box Warning and Why Does Paxil Have One?

A black box warning is the strongest warning that the U.S. Food and Drug Administration (FDA) requires on the packaging of a pharmaceutical product. It is designed to alert both the healthcare provider and the consumer of any serious safety concerns. The idea behind the method is that the thick black bar surrounding the warning will draw attention to the warning contained within describing the risks of the medication.

For a drug to receive a black box warning, the FDA must have deemed the drug’s risks as being substantially dangerous. Though the black box warning is serious, it does not mean that patients should abandon their medication. Rather, it means simply that the patient should be well aware of the risk inherent in the product and ask the appropriate questions of the medical provider that prescribed the medication to ensure his or her safety.

Why Did The FDA Place A Black Box Warning On Paxil?

In response to studies indicating that certain antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults, the FDA required that such antidepressants place a black box warning on the product informing consumers of the risk. Paxil belongs to this class of antidepressants, and thus, GlaxoSmithKline was forced to place the warning on the product.

What If I Have Been Harmed By Paxil?

Despite the conspicuous nature of the black box, many patients never see the warning contained within and thus are never informed as to the risks of taking the medication. In other cases, as in Paxil, the black box warning does not describe all the risks inherent in the product. Paxil’s black box warning pertains only to the risks of suicidal ideation – and nothing of the serious birth defects that may be caused to children born to mothers taking the medication during pregnancy.

If you have suffered through Paxil birth defects then you could be entitled to compensation from GlaxoSmithKline for the harm you have suffered. The attorneys at the Rottenstein Law Group have been capably representing clients’ interests against powerful corporations for a collective 25 years and are currently consulting clients regarding Paxil litigation. For a free consultation with an RLG attorney please fill out this brief contact form.