Paxil (paroxetine) is a selective serotonin reuptake inhibitor, or SSRI antidepressant medication which may have caused severe side effects and birth defects which were serious, permanent or life-threatening in a number of users. Paxil’s maker, GlaxoSmithKline (GSK), has paid $ billions in settlements and compensation for injuries, birth defects, and wrongful death caused by the medication.
Paxil Lawsuit Claims
GlaxoSmithKline has faced hundreds of medical injury lawsuits for injuries, birth defects and deaths associated with Paxil use. The medication was also the subject of a class action lawsuit filed by people who claimed Paxil caused them to become addicted to the drug and included over 1500 participants.
GSK has settled hundreds of lawsuits and claims against Paxil due to suicide, withdrawal, birth defects and other serious claims and has paid $billions in fines and settlements to resolve these cases.
Paxil Lawsuit Information
Paxil (paroxetine) is a selective serotonin reuptake inhibitor, or SSRI antidepressant medication approved in 1992. It was the third member of the SSRI medications which were a “new” type of antidepressant, intended to have fewer and less severe side effects than older antidepressants.
Many people who have taken the medications have experienced side effects which are unexpected, severe or may be life-threatening. Some of these Paxil users or their family members may have chosen to file lawsuits to seek compensation for their injuries, birth defects or wrongful death that may have been caused by the drug.
Paxil’s maker, GlaxoSmithKline (GSK), has paid $ billions in settlements and compensation for injuries, birth defects, and wrongful death caused by the medication. GSK has also been named in antitrust claims and was ordered to pay a fine of $3 billion in fees to settle U.S. Department of Justice charges and lawsuits with other governmental agencies over claims Paxil had been illegally promoted as safe for treating depression in children, despite not having received the go-ahead from the FDA for use by people younger than 18.
Warnings about Paxil
Paxil has been the subject of more than 40 warnings from drug regulatory agencies through seven countries. In 2011, the US Food and Drug Administration (FDA) warned health professionals about the increased risk of persistent pulmonary hypertension (PPHN) in newborn babies whose mothers had taken Paxil. This came after warnings about the risk for other types of birth defects in babies born to mothers using Paxil.
Warnings for Paxil were also issued in Australia about increase in death rates among female Paxil users and a public health warning was issued in the U.S. about Paxil’s risk for inducing serotonin syndrome. This condition can cause hallucinations and hypertensive crisis, and in some cases, be fatal.
Side Effects of Paxil
Like all drugs, Paxil use triggers many different side effects. Some of these are mild, but others are severe and potentially fatal including increased suicide risk, serotonin syndrome and drug withdrawal. In addition to serious side effects that may occur in users of Paxil, the drug has also been linked to an increased risk of birth defects.
In 2004, along with other medications, the U.S. Food and Drug Administration began requiring that Paxil include a black box warning on the top of all prescribing information. Paxil’s black box statement warns that the medication may increase the risk of suicidal thoughts or behaviors. The risk is most prevalent when the medication is first started or dosage is changed and particularly affects children, adolescents and young adults.
Paxil Birth Defects
Like other SSRI antidepressants, Paxil was originally classified as a Category B Pregnancy medication but after reports of birth defects emerged, most SSRIs were reclassified as Category C, however Paxil was upgraded even further and is now considered Category D Pregnancy medication, indicating that birth defects have been seen in humans and that risks may outweigh any benefits of the medication.
Common birth defects linked to Paxil use include:
- Septal heart defects
- Pulmonary stenosis
- Pulmonary atresia
- Malformed limbs
- Underdeveloped or missing parts of skull
- Spina bifida and scoliosis
- Pulmonary Hypertension of Newborn (PPHN)
- Cleft lip or cleft palate
- Autism Spectrum Disorder (ASD)
Data shows Paxil users who become pregnant have twice the risk of giving birth to baby with birth defects versus mothers using other antidepressants. Some infants were also born with an addiction to the drug and experienced serotonin withdrawal syndrome after birth. Mothers who used Paxil during the final few months before giving birth were at a greater risk of giving birth to babies with an addiction to the drug.
Paxil Lawsuit Claims
Some users have reported an addiction to Paxil, while others have claimed injury including wrongful death due to suicide or other harm, and birth defects.
- A number of class action lawsuits were filed after users claimed it was difficult for them to stop use of the drug. Users stated they had withdrawal symptoms that damaged their daily life. A lawsuit was filed in Los Angeles, California in 2001 by lawyers seeking funds for Paxil users who had become dependent on the drug. More than 1500 Paxil users took part in the lawsuit.
- Lawsuits filed against Paxil have also claimed that GSK, manufacturer of Paxil withheld data that showed withdrawal was a potential risk. While GSK maintained that there is no evidence that Paxil can produce addiction or dependence, the company has settled hundreds of addiction lawsuits for $millions.
- Paxil also may have increased the risk of suicide or other abnormal behaviors. GSK faced about 450 Paxil lawsuits filed as a result of user suicide and the company has paid more than $390 million in settlement money.
Thousands of lawsuits have been filed and adjudicated or settled against GSK for injuries and deaths associated with Paxil use. The company is estimated to have paid over $1 billion in fines and settlements.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.