Paxil (paroxetine) is an SSRI antidepressant which is used to treat depression and other mental disorders such as OCD, PTSD and anxiety disorders. Paxil’s manufacturer, GlaxoSmithKline has faced thousands of Paxil lawsuits for birth defects, side effects and injuries caused by the medication.
GlaxoSmithKline, manufacturer of Paxil, has faced thousands of lawsuits in federal, state and local courts throughout the U.S. for injuries caused by the drug. GSK has paid $millions in settlements and awards for damages in cases involving birth defects, suicide and other serious side effects or injuries.
Drug Warning: Paxil
|Classification||serotonin-specific reuptake inhibitor (SSRI) antidepressant|
|Dosage form(s)||10mg tablet|
10mg/5ml oral suspension
|Normal dosage||10 to 60mg daily|
Paxil is a selective serotonin reuptake inhibitor (SSRI) which treats depression and other mental disorders. It works by increasing neurotransmitter, serotonin, levels in mood centers and certain areas of the brain.
Paxil is approved to treat:
- Major depressive disorder (MDD)
- Obsessive-compulsive disorder (OCD)
- Panic disorder (PD)
- Social anxiety disorder (SAD)
- Generalized anxiety disorder (GAD)
- Post-traumatic stress disorder (PTSD)
Paxil Side Effects
All medications cause side effects, including Paxil. Most side effects are mild to moderate and many will go away over time. Other Paxil side effects are more severe, may be long-lasting, serious or even life-threatening.
Common side effects of Paxil:
- Dry mouth
More severe side effects of Paxil:
- Suicidal thoughts and behaviors
- Increased risk of bleeding
- Serotonin syndrome
- Discontinuation syndrome
- Birth defects
- Hypersensitivity reactions
- Heart rhythm changes
Data shows that Paxil has been issued more than 40 warnings from drug regulatory agencies throughout the world concerning the safety of the medication. The Australian Therapeutic Goods Administration warned of an increase in death rates among female Paxil users and in the United States, a public health advisory was issued concerning serotonin syndrome that included hypertensive crises, hallucinations, and death.
In 2004, the U.S. Food and Drug Administration (FDA) began requiring all antidepressant medications including Paxil to include a “black box warning” on all prescribing information. A black box or boxed statement warning is the most severe warning that the FDA can issue without withdrawing a medication from the market. The black box statement is enclosed in a box with a thick, black border at the top of all prescribing information.
Paxil’s black box warning states that use of the antidepressant may increase the risk of suicidal thoughts and behaviors in children, adolescents and young adults. The increase in suicidal tendencies does not appear to affect adults over the age of 24 and may decrease the risk in geriatric patients, over the age of 65.
In addition to black box warning regarding suicide, Paxil may cause other side effects which are serious or life-threatening. These side effects include cardiac effects, seizures, serotonin syndrome, withdrawal and the possibility of birth defects.
Paxil Serotonin Syndrome
Serotonin syndrome is caused by a large increase in the amount of serotonin in the brain and body.
It may cause symptoms such as:
- Agitation or restlessness
- Muscle rigidity or twitching
- High fever
- Heavy sweating
- Irregular heartbeat
- Loss of consciousness
Serotonin syndrome may be serious and requires medical treatment. Sudden symptoms or rapidly worsening condition should be treated as a medical emergency.
Paxil Birth Defect
When first introduced, most SSRI antidepressants were listed as Pregnancy Category B, generally indicating that they were considered safe to use during pregnancy. Paxil however, was upgraded to a Category C medication, indicating a possibility of affecting the pregnancy with negative effects to either mother or fetus.
In September of 2005, after review of two studies indicated that Paxil had been linked to a small but definite increase in birth defects, the FDA required that Paxil be moved to Category D and issued a warning notice that women who are pregnant should avoid taking Paxil. In December of the same year (2005), the warning was strengthened after analysis of study results indicated that the risk of certain cardiac birth defects may be 1.5 to 2 times higher with Paxil use.
More than one study has claimed that Paxil use may also be associated with Autism Spectrum Disorders and even though there appears to be a large number of anecdotal reports and some clinical evidence, GSK has not acknowledged a link, nor has the FDA required labeling additions.
Birth defects related to Paxil use may include:
- Heart abnormalities
- Intestinal disorders (omphalocele, anal atresia, pyloric stenosis)
- Digestive disorders
- Spina bifida
- Club foot
- Cleft lip or palate
- Hearing or speech impairment
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Uncontrollable high-pitched crying
- Autism Spectrum Disorders
Babies born to mothers who have taken Paxil during pregnancy may be experiencing symptoms similar to serotonin withdrawal resulting in agitation, difficulty feeding, and abnormal muscle tone. Many of the lawsuits filed against GlaxoSmithKline have been due to Paxil-related birth defects.
In 2011, the U.S. Food and Drug Administration updated the public on the use of SSRIs among pregnant women. It issued this safety announcement because of consistent findings that SSRIs increased the potential risk of PPHN, a rare heart and lung condition. The warning advised health care professionals not to alter current clinical practices to treat depression during pregnancy.
Other Paxil Lawsuits
Withdrawal – People who have tried more than one antidepressant medication report that Paxil is the most difficult to discontinue and many have experienced serious withdrawal symptoms. In 2001, more than 1500 Paxil users participated in a lawsuit after struggling to break their addiction to the medication. The company has insisted there is no medical data backing up the claims Paxil is addictive, but it has settled lawsuits for millions of dollars in damages.
Birth defects – The first lawsuit against Paxil’s manufacturer, GlaxoSmithKline, for a child born with persistent pulmonary hypertension (PPHN), a life-threatening lung condition that can cause serious permanent damage in infants who live, was filed in 2006. Other lawsuits involving babies born with heart defects were filed against GlaxoSmithKline in 2006 and 2007. In each of these cases, the mothers had taken Paxil during their pregnancies.
Suicide Risk – The first suicide Paxil lawsuit to go to trial involved an adult U.S. patient. A Wyoming federal court jury awarded an $8 million verdict in favor of the family of a man who killed his wife, daughter and granddaughter before taking his own life. The man used Paxil for just two days before the murder-suicide. More than 400 lawsuits have included claims Paxil led to the suicide of users and more than $390 million has been paid in compensation to surviving loved ones.
Improper marketing – GSK also faced accusations of illegal promotion of the drug, and the company settled one such lawsuit for $3 billion after they were accused of marketing the drug as safe and effective for children with depression, despite the FDA had never approved it for this purpose.
GlaxoSmithKline had set aside $3 billion to be put toward lawsuits regarding Paxil. Many lawsuits have already been settled but Paxil or paroxetine may continue to pose potential risks to patients who take the medication. As such, Paxil attorneys and lawyers will remain watchful.