Paxil Addiction

Paxil Addiction

In 2012 the drug company GlaxoSmithKline agreed to pay $8.5 million to settle claims stemming from Grair v. GlaxoSmithKline, a class-action lawsuit filed in California. Plaintiffs alleged that the company promoted Paxil as a non-habit-forming, non-addictive drug and withheld information about a withdrawal syndrome experienced when you stop using the drug. The company’s literature and the Paxil label never referred to “withdrawal syndrome,” a term used in drug addiction literature, but rather to “discontinuation syndrome.” GlaxoSmithKline advised ABC Primetime News in 2004 that only 2% of patients experience discontinuation symptoms even though their internal documents indicated that the rate was actually 62%.

Paxil is not classified as an addictive drug by the U.S. government even though it has one thing in common with all addictive drugs: when most people stop using it, they experience a difficult withdrawal syndrome. This puts them in the position of having to choose between taking another Paxil to get through the day and to be able to go to work or to endure a syndrome that can include headaches, “electric shocks” in the brain, uncontrollable diarrhea, breathing problems, chest pain, and delirium. Symptoms can last for two months and become so hard to manage that many people simply give up and assume they will have to take Paxil for the rest of their lives.

GlaxoSmithKline has a history of misleading the public and physicians not only about withdrawal but also about the effectiveness and safety of Paxil. In July 2012, these practices finally caught up with them. GlaxoSmithKline pled guilty to criminal and civil charges and was asked to pay a record $3 billion in fines for misbranding and misleading the public about Paxil and two other drugs.

The U.S. Department of Justice alleged that “GlaxoSmithKline unlawfully promoted Paxil for treating depression in patients under age 18, even though the U.S. Food and Drug Administration (FDA) has never approved it for pediatric use. Among other things, GlaxoSmithKline participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GlaxoSmithKline did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18.”

Between 1997 and 2006, Paxil sales were $11.6 billion in the USA alone, and today over one in every ten Americans over age 12 years old is taking Paxil or some similar antidepressant.

What is Paxil?

Paxil, the trademarked name for paroxetine, is an antidepressant in the same family of drugs as Prozac and Zoloft. GlaxoSmithKline introduced the drug in 1993 and by 2000 it ranked seventh worldwide among all drugs in sales.

Paxil and its cousins are “Selective Serotonin Uptake Inhibitors (SSRIs)” that work by altering certain chemicals in the brain. Neurotransmitters are brain chemicals manufactured and released by nerve cells, and they can travel to other nerve cells, thus proving communication between cells. Serotonin is a neurotransmitter that is released by brain nerve cells when a person experiences pleasure. When the happy moment ends, serotonin goes back into its original cells of origin. This is called “reuptake.” SSRIs stop the serotonin reuptake process, which means more serotonin stays in the brain.

The chemical name for paroxetine is (3S,4R)-3-[(2H-1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine.

When SSRIs were first introduced in the 1990s, they were considered breakthrough drugs because they had fewer side effects than older generations of antidepressants. Celebrities like Brooke Shields, Winona Ryder, Johnny Depp, and Christina Ricci publicly talked about how helpful the drugs were to them, and they soon became somewhat chic. People talked in terms of the “Prozac Nation” and the prozac-ation of the United States, as the numbers using the pills approached the millions.

What Are the Medical Uses of Paxil?

In the 1990s the FDA approved Paxil for depression, panic disorder, obsessive-compulsive disorder, and social phobia, and approved for general anxiety disorders in 2001. The drug is also used to treat premenstrual tension syndrome and posttraumatic stress syndrome. Paxil controls but does not cure any of these conditions, which means it can become a lifelong drug for many users.

Paxil comes in tablets in strengths of 10, 20, 30, and 40mg. Paxil also comes as extended release tablets in strengths of 12.5, 25, and 37.5mg. A liquid suspension and strength of 10mg is also available.

The usual dosage for depression, social anxiety, general anxiety, obsessive-compulsive disorder, and posttraumatic stress syndrome is 20mg once a day, but a doctor can prescribe up to 60mg per day. The usual starting dose is 10mg per day for panic attacks.

What Drugs Interact with Paxil?

When doctors prescribe Paxil, they warn patients to wait two weeks if they have taken a monoamine oxidase inhibitor (MAOI) before using Paxil. Likewise, you should wait two weeks after your last Paxil before you take an MAOI. The drugs can cause a fatal interaction. Common MAOIs approved by the FDA are Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam, Eldepryl, Zelapar) and Tranylcypromine (Parnate).

If you take too much Paxil or if the drug is combined with MAOIs or other drugs that affect the serotonin levels in the brain, you put yourself at risk for serotonin syndrome, a potentially fatal condition in which too much serotonin accumulates in the body. Paxil should not be taken in combination with other SSRIs like Celexa (citalopram), Luvox (fluvoxamine), Prozac (fluoxetine), and Zoloft (sertraline); Selective Serotonin-Norepinephrine Reuptake Inhibitors like Cymbalta (duloxetine) and Effexor, Effexor XR (venlafaxine); triptans like Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan) and Imitrex (sumatriptan); tricyclic antidepressants like Elavil (amitriptyline), Tofranil (imipramine), Sinequan (doxepin) and Anafranil (clomipramine); antidepressants and psychiatric medications such as Wellbutrin (bupropion), Desyrel (trazadone), BuSpar (buspirone) and Eskalith (lithium); narcotic painkillers such as Codeine, Fentanyl and Tramadol; antibiotics like Zyvox (linezolid) and Norvir (ritonavir); and certain street drugs like amphetamine, cocaine, and LSD (lysergic acid diethylamide).

Paxil combined with Mellaril or Orap can cause heart problems. Paxil can affect bleeding so it should not be combined with drugs like aspirin, Aleve, Advil, Motrin, ibuprofen, Warfarin, and Coumadin that also affect bleeding. These interactions can cause gastrointestinal bleeding. Dilantin and phenobarbital reduce the effect of Paxil.

Other drugs that should not be combined with Paxil are alcohol, Zyvox, sedatives, narcotics, sleeping pills, muscle relaxants, tamoxifen, seizure and anxiety medications, and drugs for colds or allergies.

You should not take Paxil with St. John’s wort or ginseng.

Who Should Not Take Paxil?

Paxil cannot be taken by people who have kidney or liver diseases , because they will metabolize and eliminate Paxil too slowly than and can develop high blood pressure.

People with bleeding or clotting disorders, seizures, glaucoma, bipolar disorder, histories of drug abuse or suicidal thoughts, heart disease, and/or histories of heart attacks, low sodium, or bone problems should not take Paxil.

Pregnant women should not take Paxil because it is classified as a Category D drug or one that presents risks to the fetus. Specifically, the FDA warned in 2006 that mothers who took Paxil during pregnancy had babies that were six times more likely to have persistent pulmonary hypertension, and twice as likely to have certain serious heart defects.

People with bipolar disorder should not take Paxil for depression because it can induce states of mania, especially once it is discontinued. In one study of 73 patients with bipolar disorder being treated through the National Institute of Health, researchers concluded that “antidepressant discontinuation actually induces mania in spite of mood stabilizing treatments.”

Since Paxil can lower the sperm count in men, it should not be taken by those who want to become fathers.

Paxil is usually not prescribed to elderly patients because it increases their risk for bone fractures. Also the elderly would metabolize and eliminate Paxil more slowly than younger people.

Patients who have low sodium counts should not take Paxil because it can induce a life-threatening syndrome.

Should Children Take Paxil?

In three unpublished studies of Paxil involving over 300 children under 18 years old, the drug was found not to be any more effective than sugar pills. Even more disturbing, 5.3% of the children taking Paxil for depression had an increase in suicidal thoughts and events of attempted suicide and self-harm compared to 2.8% of the children taking a placebo. Among those taking Paxil for social anxiety, 2.4% had suicidal events compared to zero taking the placebo. Writing in the Canadian Medical Association Journal in 2003, the authors concluded that Paxil is not indicated for children.

Paxil is also not prescribed to children in Great Britain. The British Medicines and Healthcare Products Regulatory Agency concluded in 2003 that “the benefits to children do not outweigh the risks,” after going through nine scientific studies of Paxil in children that concluded the drug is ineffective and causes some to become suicidal.

In the United States, where SSRIs are much more frequently prescribed to young people, the Paxil story was more complex. Although the FDA had not approved Paxil for children, many doctors were prescribing it off label to pediatric patients since its introduction in 1993. An influential article published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry concluded that Paxil was “generally well tolerated and effective for major depression in adolescents.” This article was later cited as misrepresentative and as promoted by GlaxoSmithKline in the Department of Justice’s lawsuit against that company.

Between 1993 and 2003, GlaxoSmithKline kept heavily promoting Paxil and downplaying any negative research to healthcare professionals. Revenue for sales of Paxil to pediatric patients amounted to $55 million in 2002 alone.

In October 2003, the FDA notified healthcare professionals about the potential risk for suicidal ideation in children and young people taking Paxil, and in March 2004, the FDA published a Public Health Advisory that told parents, doctors, and others involved with patients under 24 years old to monitor them at the beginning of their Paxil treatment for suicidal thinking and/or attempts. In 2004 New York State Attorney Elliott Spitzer sued GlaxoSmithKline for misrepresenting data about the effectiveness and safety of Paxil when prescribed to children. He noted that GlaxoSmithKline held back four studies that concluded Paxil did not help children with depression.

In October 2004 the FDA required that all bottles of antidepressants, including Paxil, must carry a “black box warning” about the increased risk of suicide among pediatric patients under age 24 years old taking these drugs. A black box warning is the most severe that the FDA can use, but yet it does not prohibit the use of SSRIs in children. By this time, antidepressant prescriptions to children were 7% of total sales.

Many American parents and doctors objected to the black box warning, because they were convinced that children were being helped by these drugs and would be in worse danger of suicide without them. Indeed, the suicide rate among adolescents actually went up 14% in the first year after the black box warning was issued, and most experts attributed the new suicides to the decrease in usage of antidepressants among adolescents.

Subsequent studies have shown that a small minority taking Paxil are at increased risk during the first months on the drug, but the risk went away as they got used to the drug. Research that combined studies of 77,000 people of all ages found that there would be 14 cases of suicidal ideation per 1,000 subjects taking the drugs, and five cases without the drugs. The researchers did not know if the risk for suicide would persist for more than a few months after the introduction of the drug.

Apparently, Paxil increases the energy levels of depressed patients, especially among the young, when they first start taking it, and this in turn increases their chance of committing suicide.

What Are the Side Effects of Paxil?

Since literally hundreds of thousands of people take Paxil, some experience certain side effects and others will not. About 20% of patients with depression stop using Paxil because of an adverse event. The rate of stoppage for those with social anxiety is 16%, and about 11% for patients with other conditions. Common side effects of Paxil cited by depressed patients are agitation, impulsivity, insomnia, mania, hostility and aggression.

The most common side effects for Paxil are mild and often go away after a few weeks. These might be headaches, drowsiness, dizziness, insomnia, restlessness, nervousness, nausea, constipation, decreased sexual drive, impotence, dry mouth, and yawning. Some patients complained of not being able to sit still and the need to move all the time, as well as recklessness, feeling overly energetic, irritability, abnormal behaviors, and feeling easily upset.

Rarer side effects are dilated eyes, sensitivity to light, rashes or skin patches, acting excited, coma, and inability to move eyes. Other rare but serious side effects can be bone pain or tenderness, easy bruising, coughing up blood, unusual bleeding, fever, fast heart rate, tremors, trouble concentrating, and skin reactions.

As their bodies adapt to increased levels of serotonin, some people develop less ability to experience emotions, particularly pleasure, and may complain they feel like robots. This condition can be called “anhedonia.”

Paxil can cause severe inner restlessness known as akathisia, which in turn increases the risk for suicidal behavior.

What Are the Risks of Taking Paxil?

The most serious risk for taking Paxil occurs among young people in the first few months of taking it. The drug increases their energy levels, feelings of restlessness and inner turmoil, which in turn increases their risk for suicide.

Paxil has not been sufficiently studied for its addictive potential for abuse, tolerance or physical dependence.

Paxil causes a severe and difficult withdrawal syndrome in up to 80% of patients. The manufacturer calls it a “discontinuation syndrome.”

Paxil causes a lessening of the sex drive and feelings of pleasure during sex for both women and men, and lowers the sperm counts in men.

Some people are highly allergic to Paxil and will experience a life-threatening syndrome that requires medical attention. Symptoms are swollen face, tongue, lips and throat, difficulty breathing, hives, and skin rashes.

What are Paxil Overdoses?

Taking too much Paxil or taking it in combination with the wrong drugs can produce symptoms such as dizziness, drowsiness, flushed face, large or dilated pupils, racing heartbeat, trembling, and shaking. The syndrome can get worse, though some people can get better on their own. It is best to seek immediate medical attention.

What Is Paxil Discontinuation Syndrome or Paxil Withdrawal Syndrome?

Paxil was marketed as a non-addictive drug with few side effects. Its manufacturer told doctors that up to 21% of patients could experience a “discontinuation syndrome” when they stopped taking the drug, even though the company’s internal documents indicated 62% would experience the syndrome.

Although some Paxil users were chattering to one another on the Internet about how difficult it was to withdraw from the drug, their complaints were largely ignored by the media until a primetime broadcast by ABC News in 2004. The segment featured professionals unable to go to work unless they took their pills, as well as people struggling with extraordinarily difficult symptoms such as painful “electric zapping” in their heads, confusion, debilitating headaches, tremors, vertigo, and depression. One woman described it as a nail being pounded into her head, and said, “At one point I’d do anything to get the drug so I could go back to work.”

Another described Paxil discontinuation syndrome as “having a major nervous breakdown every time I tried to get off it.” One man who had never been clinically depressed became addicted to Paxil for ten years after being prescribed the drug to help him get through the loss of his daughter and girlfriend.

Before the ABC segment, people experiencing this syndrome would tell their doctors about it, and their physicians, who had been given false information, would assume that the patient was still depressed and needed to continue on Paxil. Some people did not even connect their symptoms to Paxil withdrawal because they had never been told that such a syndrome was possible.

What’s worse is that Paxil withdrawal can last 2 to 8 weeks. The withdrawal syndrome is supposedly worse than that for other SSRIs. Paxil washes out of the body quickly, so withdrawal can occur equally quickly, even among those who have only taken the drug a few days.

The Mayo Clinic lists Paxil withdrawal symptoms as crying, out of control actions, pins and needles, depersonalization, dysphoria, electric shocks, fears, unhappiness, sweating, muscle pain, headache, nervousness, paranoia, emotional overreactions, rapid mood changes, drowsiness, dullness, sluggishness, and weakness.

People in withdrawal from Paxil report other symptoms like “brain shocks,” uncontrollable diarrhea, stomach problems, tremors, nightmares, vertigo, vomiting, mood swings, insomnia, convulsions, restlessness, disorientation, sexual problems, homicidal thoughts, sweating, vision changes, tiredness, weakness, chest pains, and behavioral changes.

Not everyone who takes Paxil has trouble discontinuing the drug. The problem is that the number of prescriptions written for Paxil in 2011 was 14 million, which means that even if a small percentage of people have a problem with it, it still adds up to a lot of people who need help.

How Do I Know If I Am Addicted to Paxil?

If you can answer yes to one or more of the following questions, it may be time to talk to your doctor or to the professionals at a local mental health clinic about your use of Paxil.

  • When you try to stop taking Paxil, do you experience severe withdrawal symptoms?
  • Are you unable to handle Paxil withdrawal symptoms on your own?
  • Have you tried to wean yourself off Paxil and failed?
  • Do you find that you are unable to go to work or school or otherwise function unless you take Paxil?
  • Does Paxil seem to be less effective for you now than it was when you first started taking it?
  • Have you been taking Paxil for a year or more?
  • Do you worry that you will have to take Paxil the rest of your life?
  • Would you like to try to stop taking Paxil but are uncertain how to go about it?
  • Are you taking Paxil without a prescription?
  • Are you taking Paxil along with illegal drugs?
  • Are you unsure if the benefits of taking Paxil outweigh its unpleasant side effects?
  • Do you think that you could benefit from a combination of drugs and psychotherapy as a way of treating your depression, posttraumatic stress syndrome, or social anxiety?

What Treatment or Help Is Available for Paxil Addiction?

If you are taking Paxil under a doctor’s recommendation, you should ask him or her about discontinuation syndrome. You should not try to withdraw from the drug on your own or even taper off your dosage without the advice of your physician.

If you’ve been taking Paxil for a number of years and have tried to withdraw on your own, you should seek professional help from your doctor or addiction specialists at your local mental health clinic. In some cases, people who have been using Paxil a long time and in great amounts have had to enter residential treatment centers to get through the withdrawal process. You may have to devote several weeks to getting through Paxil discontinuation syndrome, and you should not feel like a failure if you cannot do it yourself. You and your physician may decide that the best course for you is to remain on a drug-oriented therapy.

Drugs like Paxil have literally been lifesavers for millions of people with difficult and life-threatening psychiatric diseases. Nevertheless, companies like GlaxoSmithKline are spending millions of dollars a year advertising their products and promoting the idea that depression and other maladies are chemical imbalances in the brain. However, for some people, just taking drugs for a chemical imbalance is not enough. Some patients suffering from psychiatric problems such as clinical depression, posttraumatic stress syndrome, panic disorders, and social anxiety benefit from a holistic approach that includes psychotherapy and lifestyle changes as well as drug therapy. Residential treatment centers offer such a holistic approach.

Sources:

“Paxil Class Action Lawsuits,” Law Information, see http://lawsuits.lawinfo.com/Paxil/paxil-class-action-lawsuit.html

“Paxil Addiction,” ABC Primetime News, December 9, 2004

see http://www.youtube.com/watch?v=hfQUTHrWnRk

“GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,” The U.S. Department of Justice, July 2, 2012, see http://www.justice.gov/opa/pr/2012/July/12-civ-842.html

Ibid.

“One in Ten Americans Taking Antidepressants,” Reuters News, October 19, 20see http://www.reuters.com/article/2011/10/19/us-usa-antidepressants-idUSTRE79I7FI20111019

Harris, Gardiner. “Britain Says Use of Paxil By Children Is Dangerous,” The New York Times, June 11, 2002.

Abelson, Reed. “Court Battle Over Paxil,” The New York Times, Feb. 5, 2003.

“Paxil Is Approved for Anxiety Disorder,” The New York Times, April 17, 2001.

“Paxil,” Drugs.com, see  http://www.drugs.com/paxil.html

“Paxil Is Approved for Anxiety Disorder,” The New York Times, April 17, 2001.

“Paroxetine Warning,” The U.S. Library of Medicine, PubMed, see http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001037/

“Paroxetine,” The U.S. Library of Medicine, PubMed, see http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001037/

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

“Monoamine oxidase inhibitors”, The Mayo Clinic, see http://www.mayoclinic.com/health/maois/MH00072

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

“Paxil,” Drugs.com, see  http://www.drugs.com/paxil.html

Ibid.

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

“Paxil,” Drugs.com, see  http://www.drugs.com/paxil.html

Goldstein, Tina; Mark A. Frye, M.D.; Kirk D. Denicoff, M.D.; Earlian Smith-Jackson, R.N.; Gabriele S. Leverich, L.C.S.W.; Ann L. Bryan; S. Omar Ali; and Robert M. Post, M.D. “Antidepressant Discontinuation-Related Mania: Critical Prospective Observation and Theoretical Implications in Bipolar Disorder,” Journal of Clinical Psychiatry 1999;60:563–567.

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

“Paxil Clinical Warnings and Precautions,” the RX List, see http://www.rxlist.com/paxil-drug/warnings-precautions.htm

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

Wooltorton, Eric. “Paroxetine (Paxil, Seroxat): increased risk of suicide in pediatric patients,” The Canadian Medical Association Journal,  September 2, 2003 vol. 169 no. 5.

Harris, Gardiner. “Britain Says Use of Paxil By Children Is Dangerous,” The New York Times, June 11, 2003.

Keller, Martin (MD) et al. “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial,” Journal of the American Academy of Child & Adolescent Psychiatry

Volume 40, Issue 7 , Pages 762-772, July 2001.

“GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,” The U.S. Department of Justice, July 2, 2012, see http://www.justice.gov/opa/pr/2012/July/12-civ-842.html

Ibid.

Gilprin, Kenneth. “New York Sues Maker of Antidepressant Drug Paxil,” The New York Times, June 2, 2004.

1Ibid.

“New warning label ordered for antidepressants,” The Associated Press October 12, 2004, see http://www.msnbc.msn.com/id/6254504/ns/health-childrens_health/t/new-warning-label-ordered-antidepressants/

Carey, Benedict. “Suicide Rises in Youth; Antidepressant Debate Looms,” The New York Times,  September 7, 2007.

Bakalar, Nicholas. “Suicide Findings Question Link to Antidepressants,” The New York Times, July 10, 2007.

“Paxil Clinical Warnings and Precautions,” the RX List, see http://www.rxlist.com/paxil-drug/warnings-precautions.htm

Friedman, Richard. “What You Do Know Can’t Hurt You,” The New York Times, August 12, 2003.

“Paxil Table of Side Effects,” The RxList, see http://www.rxlist.com/htmlchunks/rxlist_tablePopup.html

Ibid.

“Paxil,” Drugs.com, see  http://www.drugs.com/paxil.html

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

Ibid.

“Paxil,” Drugs.com, see  http://www.drugs.com/paxil.html

American Psychiatric Association, The Diagnostic and Statistical Manual of Mental Disorders Edition IV-TR. The American Psychiatric Association Publications, June 2004.

“Paxil Clinical Warnings and Precautions,” the RX List, see http://www.rxlist.com/paxil-drug/warnings-precautions.htm

“Paxil Table of Side Effects,” The RxList, see http://www.rxlist.com/htmlchunks/rxlist_tablePopup.html

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

“Paxil,” Drugs.com, see  http://www.drugs.com/paxil.html

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

“Paxil Addiction,” ABC Primetime News, December 9, 2004

see http://www.youtube.com/watch?v=hfQUTHrWnRk

Ibid.

See anecdotes on Paxil Addiction websites and chatrooms.

Markosian, Richard. “Paxil Truth from a Ten-Year Addict,” The Utah News, December 16, 2008.

“Paroxetine,”  the Mayo Clinic, see http://www.mayoclinic.com/health/drug-information/DR601687

See anecdotes on Paxil Addiction websites and chatrooms.

“Top Psychiatric Medications for 2011,” PsychCentral, see http://psychcentral.com/lib/2012/top-25-psychiatric-medication-prescriptions-for-2011/

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