What is Paxil?

Paxil is approved by the FDA for treating certain named disorders in adults: Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder, and Post Traumatic Stress Disorder.¹

Paxil is a selective serotonin reuptake inhibitor or SSRI. SSRIs prevent serotonin (a chemical produced in the nervous system, the vascular system and the gastrointestinal tract that is thought to affect mood) from being transferred between cells.²

What does Paxil do?

SSRI anti-depressants have become very popular and and they are very commonly prescribed. However, recent research has raised questions about their effectiveness.

A group of researchers, using the Freedom of Information Act, found that studies used to get FDA approval of SSRI anti-depressants were not published accurately, that unfavorable results were not published and in some cases, were published in a way that made them falsely appear to be favorable. Paxil and other SSRIs were overall shown to be effective in approximately 30% of people taking them – about the same number as received a favorable result from taking a placebo (sugar pill).

The researchers reviewed 74 studies, involving 12 anti-depressants and over 12,000 people and found that manufacturers reports of the percentage of positive outcomes was much higher than the FDA’s. There appeared to be selective publishing of research results.³

The results of this review question both the effectiveness of these drugs, including Paxil, and the accuracy of their marketing campaigns.

GSK was fined $3 billion for health care fraud, including fraudulent marketing of Paxil

Paxil’s manufacturer, GlaxoSmithKline, has recently plead guilty to charges of fraud and agreed to pay a $3 billion fine for charges including fraud related to claims about Paxil. According to the federal charges, GSK arranged for the publication of a medical journal article which falsely claimed that Paxil was effective in treating depression in patients under 18. In fact, the GSK-sponsored studies featured in the article not only showed that Paxil was no more effective than placebo, but also led to many more instances of suicidal thought or attempts than in the control group.

While the FDA has never approved Paxil for children under 18—and now requires that Paxil carry a black box warning on suicide risks for children, adolescents and young adults—GSK developed and executed an extensive marketing campaign for Paxil, aimed at persuading pediatricians and child psychiatrists to prescribe the drug for their patients. Elaborate dinner, lunch and vacation spa programs were offered to physicians, featuring speakers paid by the company to promote the use of Paxil for children, and to make claims as to its effectiveness in treating depression in patients under 18.⁴

What should I go over with my doctor?

The Federal Drug Administration warns that Paxil causes suicidal thoughts and may cause suicide. In addition to the risk of suicide, Paxil has many more side effects, some of them life-threatening, including seizures and severe allergic reactions. The most common side effects include nausea, feeling anxious, trouble sleeping, sexual dysfunction and dizziness. Patients who have taken Paxil have also reported weight gain as a side effect.⁵

If you or your doctor are considering Paxil, be sure to inform yourself about its interactions with other medications. Like other SSRI anti-depressants, Paxil should not be taken with medications for migraine headaches, as this can cause a life-threatening condition called “Serotonin syndrome.”⁶ This condition can also be brought on by taking SSRI anti-depressants with older, monoamine oxidase inhibitor depressants (drugs that interfere with the transfer of other chemicals between cells).⁷ Antipsychotics taken with anti-depressants have been found to more than double patients’ risks of fatal heart attack and stroke.⁸

Paxil, like other anti-depressants, is not recommended for pregnant women. It can sometimes affect the development of a baby’s heart and lungs in the womb, a rare birth defect in which a newborn can’t adapt to breathing outside the womb and which can also cause multiple organ damage, brain damage and death.⁹ A 2010 study found that taking SSRIs, particularly Paxil, during pregnancy “can lead to spontaneous abortion.”¹⁰ The American College of Obstetrics and Gynecology recommends that women who are pregnant or planning to become pregnant should avoid SSRI anti-depressants “if possible.”¹¹

What if I’m already taking Paxil?

Always talk to your doctor before discontinuing any prescription medication. Sudden cessation of any SSRI anti-depressant can trigger withdrawal symptoms and persistent symptoms have been reported for Paxil.

The World Health Organization has published a warning of severe withdrawal symptoms for Paxil and recommended that doctors watch their patients and taper their dose when withdrawing from Paxil.¹² SSRI anti-depressants, including Paxil, have been found to cause some patients to suffer withdrawal symptoms lasting months.¹³ A study at the University of Bologna reported that Paxil withdrawal symptoms “appeared to be fairly common even when performed with slow tapering….”¹⁴

Learn everything you can about Paxil before you start taking it.

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¹ FDA, “Medication Guide, Paxil,” (July 2011) http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088676.pdf
² Michael W King, PhD,”Discover what is serotonin,” http://www.whatisserotonin.com; themedicalbiochemistrypage.org, LLC, “Table of Neurotransmitters,” (last modified 25 June 2012) http://themedicalbiochemistrypage.org/nerves.php#5ht
³ Turner EH et al. 2007, “Selective publication of antidepressant trials and its influence on apparent efficacy,” New England Journal of Medicine. 358: 252-260. http://www.ncbi.nlm.nih.gov/pubmed/18199864
⁴ United States Department of Justice, Office of Public Affairs , “GlaxoSmithKline to Plead Guilty and Pay $3 Billion to resolve Fraud Allegations and Failure to Report Safety Data ,” (2 July 2012) and Complaint, http://www.justice.gov/opa/pr/2012/July/12-civ-842.html
⁵ steadyhealth.com, Patient Forums, (retrieved 25 July 2012) http://www.steadyhealth.com/how_to_lose_weight_from_paxil_t62214.html
⁶ http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm124349.htm
⁷ Sternbach, H. May 2003, Serotonin Syndrome: How to avoid, identify and treat dangerous drug interactions,” Journal of Family Practice, http://www.jfponline.com/Pages.asp?AID=636
⁸ News Medical, “Combination of antipsychotic and antidepressant drugs may increase risk of CV mortality” (16 November 2011) http://www.news-medical.net/news/20111116/Combination-of-antipsychotic-and-antidepressant-drugs-may-increase-risk-of-CV-mortality.aspx
⁹ FDA, “FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies” (13 December 2011) http://www.fda.gov/Drugs/DrugSafety/ucm283375.htm
¹⁰ Perrine Broy, et al, 2010, “Gestational Exposure to Antidepressants and the Risk of Spontaneous Abortion: A Review,” Current Drug Delivery, Volume 7, Number 1, pp. 76-92(17), Bentham Science Publishers, (January 2010), http://www.ingentaconnect.com/content/ben/cdd/2010/00000007/00000001/art00010?token=005113ca7f9405847447b494a2f2d732542556b46667d33757e6f3f2f2730673f582f6b8569fdb164;
¹¹ Obstet Gynecolo, ACOG Committee on Obstetric Practice, “ACOG Committee Opinion No.354, Treatment with selective serotonin reuptake inhibitors during pregnancy,” http://www.ncbi.nlm.nih.gov/pubmed/17138801
¹² WHO Drug Information, Vol. 6 (2002) http://apps.who.int/medicinedocs/en/d/Jh3000e/2.10.html#Jh3000e.2.10
¹³ Green, Ben (January 2003) “Persistent Adverse Neurological Effects Following SSRI Discontinuation,” Psychiatry On-Line, http://www.ncbi.nlm.nih.gov/pubmed/17224089?dopt=AbstractPlus