Paxil is the brand name of a medication containing paroxetine hydrochloride. GlaxoSmithKline (GSK) produces and sells Paxil throughout the U.S. and worldwide. Paxil is a widely used medication that was first approved for use in the U.S. by the FDA in 1992. Paxil is used to treat not only depression and other approved mental health conditions, but it has also been used for a variety of “off-label” uses as well.
Paxil presents some significant dangers to patients. The side effects include an increased risk of suicide, pregnancy complications, birth defects and more. Numerous lawsuits have been filed based on various complications arising from Paxil, and thousands of people have been injured or died as a result of taking the anti-depressant drug.
If you or a loved one took Paxil and suffered injury as a result, you could be entitled to compensation. The drug injury lawyers at Roberts & Roberts can assess your situation and assist you in getting the compensation that you deserve.
Paxil is part of a class of drugs called selective serotonin re uptake inhibitors (SSRI). It is a prescription drug that works to boost the levels of serotonin in the brain. Serotonin helps you to maintain feelings of well being, so higher levels allow you to reduce negative feelings and obtain a more positive mental equilibrium.
The FDA indicates that Paxil was approved for and is used to treat:
- Major depressive disorder (MDD)
- Panic disorder
- Obsessive compulsive disorder (OCD)
- Social anxiety disorder (SAD)
- Post-traumatic stress disorder (PTSD)
- Generalized anxiety disorder (GAD).
Paxil was also heavily marketed for off-label use, which essentially means that drug salespeople told physicians that Paxil could work to treat conditions other than those for which it had been officially approved.
Off-label uses for Paxil included treating sexual dysfunction, tingling in the limbs resulting from diabetes and chronic headaches. Paxil was also marketed for use in adolescents and children without proper approval.
In 2012, GlaxoSmithKline pled guilty to a criminal indictment based on its off-label marketing of Paxil and another drug, Wellbutrin, and paid more than $3 billion in fines and penalties.
The Dangers of Paxil
The FDA indicates that potential side effects of Paxil include:
- An increase in suicidal thoughts, especially in kids and young adults and especially after a change in dosage or within the first few months of beginning to take Paxil. In 2004, the FDA mandated that manufacturers add a “black box” warning to the product label of the drug, alerting patients to the increased risk of suicide.
- Pregnancy complications, including severe birth defects. Potential pregnancy problems and birth defects include miscarriage; persistent pulmonary hypertension (a life-threatening lung condition); premature birth; hypoplastic left or right heart syndrome; cleft lip; cleft palate; septal heart problems; brain and skull defects; club feet; developmental problems; spina bifida; and omphalocele (protruding organs or intestines coming out of the naval).
- Serotonin syndrome. Symptoms include coordination problems; muscle twitching; overactive reflexes; hallucinations; agitation; a racing heartbeat; blood pressure changes; fever; perspiration; vomiting; nausea; diarrhea; rigid muscles or coma. Death can result.
- Severe allergic reactions. Patients can develop a rash, blisters, a fever or joint pain. The eyes, mouth, face and tongue can swell up and patients may have difficulty breathing.
- Abnormal bleeding or bruising. This is especially a problem in patients who take blood thinners or who use NSAIDS such as ibuprofen.
- Seizures or convulsions.
- Manic episodes: Symptoms include sleep problems; reckless actions; excess energy; reckless behavior; fast speech; and excessive happiness.
- Reduced sodium levels in the blood. This is especially a problem for elderly people. Symptoms include weakness, memory or cognitive impairment and headaches.
In 2005, the FDA issued a news release alerting patients that studies revealed a significant increase in the risk of birth defects when Paxil was taken during the first three months of pregnancy.
The studies revealed that the risk of heart defects when babies were exposed to Paxil during early pregnancy was between 1.5 and 2 percent, compared with a 1 percent risk of defects when a mother had not taken Paxil.
The FDA advised pregnant women against taking Paxil and told GlaxoSmithKline to change its pregnancy category from C to D. This required placement of a stronger warning on the medication.
Lawsuits over Paxil
Many patients have taken legal action against GlaxoSmithKline as a result of Paxil injuries. The lawsuits primarily center on suicide and birth defects.
Patients have taken action against GlaxoSmithKline in class actions and in multi-district litigation. Patients can also file an individual lawsuit against GSK for damages caused by Paxil.
If you were injured or your child suffered birth defects because of Paxil, you may be able to obtain compensation for medical costs, lost wages, pain and suffering, emotional distress and other damages. If you lost a family member, then you may be able to obtain wrongful death damages.
An experienced drug injury attorney at Roberts & Roberts can help you understand your legal options and make a choice about how best to pursue your claim. For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.
- U.S. Department of Justice – “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data”
- FDA – Paxil Medication Guide
- Bloomberg – Glaxo Said to Have Paid $1 Billion in Paxil Suits