Paxil – Background and FDA Alerts
Paxil is a medication manufactured by GlaxoSmithKline. It is commonly prescribed for treating clinical depression and other psychiatric disorders. It is the brand name for paroxetine.
Paxil belongs to a class of medications known as Selective Serotonin Reuptake Inhibitors (SSRI). SSRIs increase serotonin levels in the brain. People who are clinically depressed have low serotonin levels. Scientists believe that changing the serotonin level can change a person’s mood.
Studies have shown that when Paxil is taken by pregnant women, their babies run a risk of birth defects that include heart problems, respiratory problems, developmental delays and death.
If you or someone you know has used Paxil and suffered harmful side effects, contact The Driscoll Firm, LLC, at 314-932-3232 to speak to an experienced injury attorney about your case. You might have a legal right to compensation.
Black Box Warnings of Paxil Risks
The U.S. Food and Drug Administration (FDA) has alerted the public about the increased risks of Paxil birth defects when taken during pregnancy. After this FDA alert was issued, a study published in the New England Journal of Medicine showed a link between Paxil and PPHN (Persistent Pulmonary Hypertension in Newborns)—a rare but serious condition that can lead to heart defects, organ failure and death.
Infants born to mothers who took Paxil after the twentieth week of pregnancy were found to be six times more likely to have PPHN than the general population. Neonatal PPHN is associated with significant morbidity and mortality.
Possible birth complications from exposure to Paxil in utero:
- Heart defects
- Respiratory difficulties
- Tremors and shaking
- Constant crying
- Low blood sugar
- Premature birth.
FDA asked the manufacturer, GlaxoSmithKline (GSK), to change the pregnancy category from C to D, which is a higher level of warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus.
In 2006, the FDA warned of an additional risk of Paxil when taken with certain other drugs, most notably migraine medications called triptans. In combination, Paxil and triptans can produce a life-threatening condition known as “serotonin syndrome.” This can cause symptoms such as respiratory failure, coma, mania, hallucinations, confusion, dizziness, hyperthermia, hypertension, sweating and trembling, and ataxia.
Contact a Paxil Litigation Lawyer Today
It is important to act promptly if you believe you have a legal claim as a result of Paxil use. Call 314-932-3232 today to speak with an experienced injury lawyer at The Driscoll Firm, LLC, about the facts of your case and the possibility of financial compensation. The Driscoll Firm, LLC, has national experience investigating and prosecuting claims of clients injured by side effects of Paxil.
John J. Driscoll solely represents plaintiffs and focuses his practice on complex product liability cases, consumer class actions and personal-injury litigation, mostly involving pharmaceuticals and medical devices. He resolved a purchaser action against SmithKline Beecham Corp. involving alleged violations of the Illinois Consumer Fraud Act and the sale of the anti-depressant drug Paxil to minors and adolescents.
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