Paxil

paxil

Paxil was approved and marketed in 1992 by the British pharmaceuticals company SmithKline Beecham, which has now become GlaxoSmithKline, a huge multi-national conglomerate in the pharmaceutical industry.  During its peak year of 2007, more than 18 million prescriptions were filled and it had become the fifth most popular antidepressant drug in the US.

Paxil (paroxetine) is a popular type of antidepressant which belongs to a group of antidepressants known as serotonin-specific reuptake inhibitors (SSRIs).

Paxil is prescribed to treat a mental disorders such as major depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety, and posttraumatic stress syndrome.  It is also used for a number of related mental disorders and other disease states such as bipolar disorder, premenstrual dysphoric disorder (PMDD), Diabetic neuropathy, and headaches.

Paxil, like other SSRI drugs has a number side effects that range from simply irritating or bothersome, to severe side effects which may be life threatening.

In 2004, the FDA found that there was an increased risk of suicide in children and adolescents taking Paxil.  The same year, the company was accused by the Attorney General of New York to be hiding information regarding suicide risks of the medication. In 2004, the FDA required the addition of a black box warning for its increased risk of suicide.

In 2005, another advisory was issued by the FDA regarding increased risks in women taking Paxil while pregnant.  The advisory cited a number of debilitating  and life-changing birth defects.

GSK has also had a number of lawsuits filed against it and settled several claims regarding accusations of packaging and mislabeling errors, sham litigation to block generic manufacturing of the medication, withholding safety information and the unlawful promotion of Paxil use in children.

What is Paxil

Paxil is the brand name for the generic medication paroxetine.  It is approved to treat a number of mental disorders such as major depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety, and posttraumatic stress syndrome.  It has only been approved for use in adult patients.

It is also used as off-label treatment for bipolar disorder, premenstrual dysphoric disorder (PMDD) – Physical and psychological symptoms that start before the onset of a woman’s menstrual cycle), Diabetic neuropathy (tingling in the hands and feet), and headaches.  Off-label use is allowed by a physician but the manufacturer is not allowed to promote or advertise off-label uses.

The SSRIs work by affecting the serotonin receptors in the mood centers of the brain.  Serotonin is a neurotransmitter (a chemical messenger) in the brain that helps maintain mood states.  Specifically, the SSRIs block the reuptake of serotonin that has been released so that it can send more “feel good” messages to the rest of the cells in the mood centers.

It is available in tablets of 10 mg, 20 mg, 30 mg, and 40 mg.  It is also available in liquid, both for oral administration.  In most cases, physicians advise that the medication will not begin to take full effect for two to three weeks after it is started.

Side Effects and Drug Interactions of Paxil

Paxil, like many other antidepressants has a number of side effects, related to its influence on the serotonin receptors in the brain.  It also may have interactions with other medications.  Most of these adverse effects are minor, but some are severe and may become life-threatening.

The most common side effects of Paxil include:

  • Nausea
  • Insomnia
  • Drowsiness
  • Anxiety
  • Irritability
  • Headache
  • Constipation
  • Weakness
  • Dry Mouth
  • Sexual dysfunction in both males and females

Paxil can also have drug interactions with other medications including:

  • Antianxiety agents such as lorazepam and alprazolam (increased sedation)
  • Dextromethorphan (tyramine reaction: headaches, pain, increased heart rate)
  • Diuretics such as furosemide and hydrochlorothiazide (low sodium levels)
  • Antihistamines such as diphenhydramine or chlorpheniramine (increased sedation)
  • Other antidepressants (increased side effects)
  • Pain relievers such as hydrocodone (increased sedation)
  • Appetite suppressants such as phentermine (nervousness, heartbeat irregularities and more severe effects)
  • Radiopaque agents for x-rays (seizures, may need to withhold Paxil prior to X-ray)
  • Caffeine and ergot combinations (serotonin syndrome – seizures, heart rate and blood pressure changes, fever and more severe effects)

Serious Adverse Events of Paxil

Some side effects of Paxil are more severe and warrant immediate emergency medical treatment:

  • Seizures
  • Confusion
  • Balance or coordination disorders
  • Fainting
  • Hallucination
  • Racing heart or abnormal heart beats
  • Allergic reaction

Paxil in Pregnancy

Paxil may cause complications for women who are pregnant and their fetus.  When Paxil is taken by pregnant women it may cause:

  • Miscarriage
  • Premature Birth
  • Hypoplastic Left/Right Heart Syndrome (HLHS, HRHS)
  • Other septal heart defects
  • Persistent Pulmonary Hypertension in Newborn (PPHN – blood vessels to lungs are under high pressure and cannot supply oxygen to the rest of the body)
  • Cranial defects
  • Spina Bifida
  • Cleft Palate or Cleft Lip
  • Ophalocele (abdominal organs on the outside of the body)
  • Club Feet or other malformation of limbs
  • Delayed development
  • Scoliosis
  • Autism spectrum disorder
  • Pulmonary stenosis and atresia

Medical groups such as the American College of Obstetrics and Gynecology (ACOG) recommends that women who are or intend to become pregnant should not use paroxetine because of an increased risk of birth defects and miscarriage or premature birth.

Paxil and Suicide

The FDA voted in 2004 to require all manufacturers of antidepressant medications to add a black-box warning to the product labels.  A black-box warning is a notification that is placed at the top of all prescribing information so that it will be the first thing seen by a physician or health care provider.  The black-box notification is the most serious warning that any medication can get.

The black-box warning on Paxil and other SSRI antidepressants identifies an increased risk of suicidal thinking and behavior in children, adolescents, and young adults following short-term use for a major depressive disorder.  The warning also advises that patients who take the medication for depression should be closely monitored for signs of suicidal type behavior and other changes.

Risperdal Events, Criminal Charges, Recalls and Lawsuits

Manufacture Criminal Indictment

In 2012 GLAXOSMITHKLINE settled the largest Health Care fraud case in U.S. history the manufacturer pled guilty to a criminal indictment and pay $3 billion in penalties and fines for the illegal promotion of Paxil and Wellbutrin, both manufactured by GSK, for the use of the medications in the treatment of children and adolescents.  Neither medication had been approved for these age groups but was reportedly being marketed for off-label use.  The indictment also included a failure to report safety data about another medication, Avandia, also manufactured by ideas GSK for the treatment of diabetes.

The manufacture was also found guilty of giving kickbacks to doctors including the provision of high-priced entertainment such as Hawaiian vacations, millions of dollars in payments for speaking tours, and tickets to Madonna concerts.

Specifically regarding Paxil, it was alleged that GSK published a medical journal article misrepresenting data from a clinical study and exaggerating data regarding Paxil’s ability to reduce depression in adolescents.

As part of a settlement , the manufacturer, did not admit any wrongdoing in the civil settlement but agreed to be monitored for five years .   Penalties were the largest ever awarded but critics have argued that they were not enough to deter pharmaceutical companies from the illegal activities.

During an approximately 10 year period, GSK’s revenue was over $28 billion for the three medications: Avandia, Paxil and Wellbutrin.  The settlement of $3 billion was less than 15 percent of sales for the three drugs.

Recalls for Paxil

In 2005, several lots of Paxil CR were recalled due to manufacturing problems at the Knoxville, TN and Cidra, Puerto Rico facilities.  However, the FDA seized additional remnants of the recalled lots because of determination that tablets could split causing the controlled release system to fail, resulting in some patients receiving too much active ingredient and others receiving little to none.

Despite the recall, GSK continued production and distribution from both plants, for several months after the recall.

Lawsuits for Paxil

Approximately 5000 lawsuits have been filed in the United States against GSK since Paxil was approved.  A portion of these claims have been class action suits and the company has paid $billions for resolution.

The first birth defect case went to trial in October of 2009.  It was found during discovery that animal studies dating back to 1980 had shown the risk of birth defects in rats.  In addition, an internal memo dating back to 1997 showed that the company would “bury” any negative results if forced to perform additional animal studes were required.

Lawyers for the plaintif argued that GSK had been negligent in its failure to warn a doctor about the use of Paxil in pregnant women and that the medication was the cause of her infant son’s heart defects and subsequent death.  A Philadelphia jury awarded the family $2.5 million in damages which was twice the amount asked for by the family.

By July 2010, the manufacturer had paid over $1.14 billion to settle over 800 lawsuits regarding birth defects.  The average lawsuit recovery regarding injuries to children has been shown to be $1.25 million by the University of Richmond Law School.

GSK also faced over 3,000 lawsuits regarding Paxil’s link to drug addiction.  The plaintiffs claimed that sufficient warning was not given about withdrawal effects occcuring after the drug was discontinued and that Paxil had specifically been marketed as “non-habit forming”.  Each case was settled for an average of $5,000.  The  company also has paid over $390 million for cases related to suicide or attempted suicide that had been linked to the drug.

GlaxoSmithKline has set aside $3 billion to help settle court cases but hundreds of cases of Paxil lawsuits are still emeging.

View Sources
  1. BBC. (2 July 2012). GlaxoSmithKline to Pay $3bn in US Drug Fraud Scandal. BBC. Accessed 24 July 2014. http://www.bbc.co.uk/news/world-us-canada-18673220
  2. Burgmann, Tamsyn. (5 December 2012) Paxil Class-Action Lawsuit: BC Court Approves Case Against Antidepressant Maker. Huffington Post. Accessed 24 June 2014. http://www.huffingtonpost.ca/2012/12/05/paxil-class-action-lawsuit-bc-court-faith-gibson_n_2245761.html
  3. CCHR (2014)Antidepressant Paxil-Studies. Citizens Commission on Human Rights International. Accessed 24 June 2014. http://www.cchrint.org/psychiatric-drugs/antidepressantsideeffects/paxilsideeffects/paxilstudies/
  4. CCHR (2014)Antidepressant Paxil-Warnings. Citizens Commission on Human Rights International. Accessed 24 June 2014. http://www.cchrint.org/psychiatric-drugs/antidepressantsideeffects/paxilsideeffects/paxilwarnings/
  5. Food and Drug Administration. (8 December 2005). FDA Advising of Risk of Birth Defects with Paxil -Agency Requiring Updated Product Labeling. Accessed 24 July 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108527.htm
  6. Food and Drug Administration. (2014) Revisions to Product Labeling - Suicidality and Antidepressant Drugs. Accessed 24 July 2014. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM173233.pdf
  7. Food and Drug Administration (2014) Paxil. Accessed 24 July 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020031s058s066,020710s022s030lbl.pdf
  8. Feeley, J., Fisk, M. (14 December 2009). Glaxo Said to Have Paid $1 Billion in Paxil Suits (Update2).Bloomberg. Accessed 24 July 2014. http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aEr_s70bGdYo
  9. Hitti, Miranda. (2005). New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants. WebMD. Accessed 24 June 2014. http://www.webmd.com/baby/news/20050927/paxils-birth-defects-warning-strengthened
  10. NAMI (2014) Depression Accessed 24 July 2014. National Institute of Mental Health. http://www.nimh.nih.gov/health/topics/depression/index.shtml
  11. NAMI (2014) Panic Disorder. Accessed 24 July 2014. National Institute of Mental Health. http://www.nimh.nih.gov/health/topics/panic-disorder/index.shtml
  12. NIH (2014) Paxil Prescribing Information. National Institutes of Health, Accessed 24 June 2014. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=65ee7ef8-cc68-41d1-cc8b-c01a056409a9
  13. Pringle, E. (2 March 2010). Paxil Birth Defect Litigation – First Trial A Bust for Glaxo. The Public Record. Accessed 24 July 2014. http://pubrecord.org/special-to-the-public-record/7086/paxil-birth-defect-litigation-first/
  14. RxList (2014) Paxil Consumer Information. RxList.com Accessed 24 June 2014. http://www.rxlist.com/paxil-drug.htm
  15. Susic, Paul. Paxil Lawsuit Related to Withdrawal Symptoms. St. Louis Psychologists and Counseling Information and Referral. Accessed 24 June 2014. http://www.psychtreatment.com/paxil_lawsuit.htm
  16. Thomas, K., Schmidt, M. (2 July 2012). Glaxo Agrees to Pay $3 Billion in Fraud Settlement. New York Times. Accessed 24 July 2014. http://www.nytimes.com/
  17. USA Today. (2 July 2012). Drug Giant Glaxo Pleads Guilty, Fined $3B for Drug Marketing. USA Today. Accessed 24 June 2014). http://usatoday30.usatoday.com/money/industries/health/drugs/story/2012-07-02/glaxosmithkline-pleads-guilty-3B-fine-illicit-promotion-prescription-drugs/55979616/