Paxil is produced by British drug manufacturer GlaxoSmithKline (GSK). It was originally approved by the FDA as an anti-depressant in 1992. Additional uses for Paxil include major panic disorder and obsessive-compulsive disorder (FDA approved in 1996), social anxiety disorder (FDA approved 1999), post-traumatic stress disorder (FDA approved in 2000), and generalized anxiety disorder (FDA approved in 2001). As Paxil has become one of the most popular SSRIs (selective serotonin reuptake inhibitor), building its yearly subscriptions to 18 million in 2007, GSK has faced severe backlash for the drug's adverse effects.
Adverse Effects of Paxil
While the FDA continually increased the approved uses of Paxil from 1992 to 2001, it was quick to react to research showing a connection between Paxil and these severe side-effects:
- Increase in suicidal thoughts (especially in adolescents and young adults)
- Discontinuation syndrome (withdrawals)
- Birth defects:
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Autism o Spina bifida
- Digestive and intestinal disorders
- Heart defects
In 2004, the FDA added a black box warning to all antidepressants (including Paxil) to warn of the increased risk of suicidal thoughts and behaviors in patients under 25.
In 2005, GSK was required to change their classification for pregnancy safety from C to D in order to more clearly establish the risks associated with Paxil use during pregnancy. In 2011, the FDA posted a public warning based on studies connecting SSRI use during pregnancy to a rare heart and lung condition, persistent pulmonary hypertension of the newborn.
GSK Agrees to Pay a Record $3 Billion to Settle Criminal and Civil Liability Cases
In 2012, GSK pleaded guilty to off-label marketing and agreed to pay a $3 billion fine to resolve the largest case of healthcare fraud in US history. The charges brought against GSK included allegations of mismarketing two drugs (Paxil and Wellbutrin), as well as failing to properly provide the FDA with safety data for the drug Avandia.
Actions taken by GSK to market and prescribe Paxil to the under-18 demographic accounts for a large portion of this settlement. GSK-sponsored events pushed forward misleading articles in medical journals and misrepresented findings in clinical trials that revealed ineffectiveness of Paxil in younger patients.
Numerous other lawsuits preceded this historic settlement:
- The first Paxil suicide lawsuit occurred in Cheyenne, Wyoming in 2001. An $8 million payout was awarded in June 2001. Over 400 lawsuits have been filed for similar suicide cases for patients of Paxil. GSK has paid out nearly $400 million for these suits.
- Also in 2001, 1,574 lawsuits were brought by patients who claimed they were addicted to Paxil and experienced severe withdrawals when they stopped taking it. These withdrawal cases resulted in a total payout of $160 million in 2006.
- In April 2007, a $64 million settlement was reached in a lawsuit alleging GSK failed to adequately warn patients of the potential dangers of prescribing Paxil to children 17 years and younger. In 2008, a class action case that alleged Paxil is ineffective and increases risk of suicidal thoughts and/or actions in young children settled for $40 million.
- In 2009, a mother who took Paxil during her pregnancy was awarded $2.5 million in damages after her child was born with birth defects. This established the blueprint for 800 similar cases to be settled in July 2010 at an average of $1.2 million per case.