Pharmaceutical

New warning of serious skin rash issued for antidepressant Paxil

paxil New warning of serious skin rash issued for antidepressant PaxilA new side effect has been added to the safety label of the antidepressant Paxil (paroxetine) following reports that some patients who used the drug developed a rare but life-threatening rash known as Stevens Johnson Syndrome (SJS).

Paxil is in a class of medications known as selective serotonin reuptake inhibitors, or SSRIs. Other drugs in this class include Zoloft, Celexa, Lexapro and Prozac. SSRIs are among the most prescribed medications in the United States and are used to treat depression and anxiety.

SJS is an allergic reaction to medication. It is most often liked to anti-inflammatory drugs and antibiotics. The condition starts with a rash that blisters over, causing the skin to peel off in sheets. SJS is extremely painful and leaves its victims at risk for serious infections. In extreme cases, it can be deadly.

The risk of SJS with Paxil was added to the Adverse Events section of Paxil’s safety label.

Paxil is also the only SSRI listed as a Category D Pregnancy Drug, meaning that it has been linked to birth defects if taken by a woman during pregnancy. All other SSRIs are listed as Category C Pregnancy Drugs, meaning that there is not enough evidence to show the drug, if taken during pregnancy, can cause birth defects.

However, new studies have suggested that other drugs in the SSRI class may be linked to serious birth defects including persistent pulmonary hypertension (PPHN), heart valve defects, neural tube defects and malformations.

Other studies have suggested SSRI use during pregnancy may contribute to autism, developmental delays, and learning disabilities. The drugs have also been shown to increase the risk of hypertension in pregnant women, which can be fatal for both mother and her unborn child.

The new safety labels for Paxil go into effect immediately.

Source: FDA