Women who take Paxil during pregnancy risk bearing children with serious complications such as persistent pulmonary hypertension (PPHN), septal heart defects, or other malformations. Our law firm is working with experienced dangerous drug lawyers across the country, who can file a Paxil lawsuit on your behalf and charge no fee until you receive a settlement or award. Contact us for a free consultation online or toll free at 1-800-992-6878.
Paxil (paroxetine) is in the selective serotonin reuptake inhibitor (SSRI) class of antidepressant drugs. It is used to treat anxiety disorders, depression, obsessive-compulsive disorder, and panic attacks. In December 1992, the FDA approved this antidepressant for sale on the market by its manufacturer, GlaxoSmithKline (GSK). Since 1992, the drug has earned GSK over $11 billion in sales (i). In 2003, the medication’s patent expired and now generic versions of the drug are available on the market.
Paxil Side Effects
This drug, like any other medication, can cause a range of side effects. The more minor side effects of this drug include, but are not limited to: drowsiness, headache, insomnia, and nausea. Among the more serious potential side effects are: birth defects, suicidal thinking, and withdrawal.
Paxil Birth Defects
The link between antidepressants and birth defects has become a growing area of study and the results of many of these studies have led the FDA to issue birth defect warnings. In 2005, the FDA changed Paxil’s pregnancy category from C to D. Category D means that adverse event data and post-marketing studies have found that the drug poses a risk to fetal development. The FDA based this change on studies which found an increased risk of septal heart defects in newborns when the mother took this antidepressant during the early stages of pregnancy (ii). In 2006, the FDA warned that a study had linked the use of the drug during pregnancy to persistent pulmonary hypertension in newborns (PPHN). The study published by New England Journal of Medicine found that PPHN was six times more common in newborns whose mother had taken SSRI antidepressants. PPHN causes the newborn to have high blood pressure in the lungs, which makes breathing difficult. In some cases, PPHN requires the newborn to use a ventilator (iii). The FDA has continued looking at studies of the connection between antidepressants and birth defects.
- Cleft lip or palate
- Down’s syndrome
- Persistent Pulmonary Hypertension (PPHN)
- Septal heart defects
- Spina bifida
- Or any other birth defects
This drug may cause the following birth defects:
Paxil Suicide Risks
On several occasions the FDA has warned about the risk of suicidal thinking in patients taking antidepressants such as this one because a growing number of adverse event reports and medical studies have established this link. For example, patients taking this drug have reported over 2,500 cases of suicidal thinking and over 1,200 cases of completed suicide to the FDA (iv). In October 2004, the FDA added a black box warning to all antidepressants regarding an increased risk of suicidal thinking in children and teenagers. In May 2007, the FDA expanded this warning to include young adults up to the age of 24. This expansion was based on 295 studies of more than 77,000 patients. The results of these studies showed that young adults taking antidepressants were two times more likely to attempt suicide than young adults taking a placebo (v). In 2009, the FDA issued another warning about the medication and the risk of suicide after reviewing data from nearly 15,000 patients. Eleven patients taking the antidepressant attempted suicide, while only 1 patient taking a placebo attempted suicide (vi).
Patients using this drug have complained about its withdrawal symptoms. For a number of years GSK advertised that the medication was not habit-forming, but the company has since recanted these claims (vii). Generally, the longer a patient uses a drug, the more likely withdrawal symptoms are to occur. Signs of withdrawal include flu-like symptoms, fatigue, severe headaches, back and neck pain, hypersensitivity to light and sound, and hallucinations.
Lawsuits Against the Manufacturer
GSK has battled several lawsuits related to this drug. For example, in 2001, the FDA began investigating GSK’s Puerto Rico manufacturing plant. Following an initial investigation, the plant was cited for numerous violations. These events came to a head in 2010 when GSK reached a $750 million settlement with the U.S. Department of Justice. Of this settlement, $96 million was awarded to a former employee of the company who “blew the whistle” on the manufacturing plant (viii). In October 2009, the first Paxil birth defect lawsuit went to trial. The jury returned a $2.5 million award for the injured family. In July 2010, GSK settled more than 800 birth defect lawsuits that were similarly attributable to this medication. The company agreed to settle these claims for approximately $1.2 billion (ix). Most recently, in July 2012, GSK pleaded guilty to fraud charges and paid a $3 billion fine. The U.S. Justice Department filed the lawsuit after it discovered that the company marketed the medication for unapproved uses (x).
Contact the Law Offices of d’Oliveira & Associates
If you or a loved one has suffered birth defects or other serious side effects from Paxil, you may have a valid dangerous drug claim. Dangerous drug attorneys, and specifically Paxil lawyers, can help evaluate your potential claim and file a lawsuit on your behalf if necessary. Our firm is currently working with qualified Paxil attorneys nationwide who handle these types of cases and could assist in pursuing yours.
Call d’Oliveira & Associates, P.C. at 1-800-992-6878 or fill out a contact form for a free legal consultation.
- (i) Bloomberg Report, July 2010.
- (ii) FDA Public Health Advisory, December 2005.
- (iii) FDA Public Health Advisory, July 2006.
- (iv) Adverse Events, October 2012.
- (v) Reuters, May 2007.
- (vi) CBS News, February 2009.
- (vii) USA Today, August 2002.
- (viii) CBS News, October 2010.
- (ix) Bloomberg Report, July 2010.
- (x) The New York Times, July 2012.