Paxil FDA Warnings

Paroxetine hydrochloride, better known by its trade name Paxil, is one of the best-selling antidepressants in the United States. A member of the selective serotonin reuptake inhibitor (SSRI) class of antidepressants, Paxil is additionally prescribed to treat social anxiety disorder, panic disorders, obsessive compulsive disorder, and other mood disorders.

While paroxetine has helped millions of people improve their mental health, it has a questionable safety record. Over the last decade, this has prompted the Food and Drug Administration (FDA) to issue a Paxil warning on several occasions. In particular, the FDA has warned the public about two of Paxil’s most severe health risks: suicide risk and birth defects.

Paxil FDA Warning About Worsening Depression

Paxil and other SSRIs are designed to boost mood by preventing the neurotransmitter serotonin from being reabsorbed. In some patients, however, paroxetine may actually worsen depression and cause suicidal thoughts and behavior.

In 2004 the FDA issued an alert to healthcare professionals and consumers, cautioning that adult and pediatric patients taking Paxil should closely watch their behavior for signs of worsening depression or suicidality (an increase in suicidal thoughts and behavior). Later that year, the FDA requested that GlaxoSmithKline (the maker of Paxil) and other SSRI manufacturers include a “black box” warning—the agency’s strongest—that describes the increased risk of suicidality in children and adolescents taking the drug. In 2007, the FDA extended this warning to Paxil users aged 18-24 years old.

FDA Cautions About Paxil Warning and Paxil Birth Defects

Aside from people under the age of 25, one of the groups of people to whom Paxil is most dangerous is unborn children. In 2005 the FDA issued a message to healthcare professionals stating that when it is taken during the first trimester of pregnancy, Paxil may increase the risk of neonatal injury (specifically cardiac malformations). This led to paroxetine’s pregnancy category being downgraded from C to D and the requirement that GSK revise Paxil’s prescribing information to warn about birth defects.

Paxil FDA Warnings

In 2006 another Paxil congenital malformation hazard was announced by the FDA. The agency cautioned that women taking paroxetine during the final 20 weeks of pregnancy risked giving birth to a child with Persistent Pulmonary Hypertension of the Newborn (PPHN), a grave condition that affects the development of a child’s lungs. Following the Paxil warning, the FDA once again mandated an update to the medication’s prescribing information.

Contact the Rottenstein Law Group for Help Filing a Paxil Lawsuit

As of 2011, thousands of lawsuits have been filed against GSK over Paxil suicide and birth defect side effects. The company has already paid around $1 billion to resolve these and other claims, and it will likely be forced to pay more to settle pending lawsuits.

If you or a loved one was injured by paroxetine, you may have be able to obtain compensation for your harm through a lawsuit against GlaxoSmithKline. To find out whether you may qualify for a financial award, contact RLG by filling out this form or calling 1-877-487-0990.

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