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Paxil

What is Paxil?

Paxil (paroxetine hydrochloride) is in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil is made by GlaxoSmithKline and was approved by the U.S. Food and Drug Administration (FDA) in 1992.

Paxil tablets and oral suspension are used to treat:

  • Depression
  • Panic Disorder
  • Social Anxiety Disorder (SAD)
  • Obsessive-Compulsive Disorder (OCD)
  • Posttraumatic Stress Disorder (PTSD)
  • Generalized Anxiety Disorder (GAD)

Paxil CR, a different formulation of Paxil, is used to treat:

  • Depression
  • Panic Disorder
  • Social Anxiety Disorder (SAD)
  • Premenstrual Dysphoric Disorder (PMDD)

Paxil FDA Alert - Serotonin Syndrome

In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs, such as Paxil) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Signs and symptoms of serotonin syndrome include:

  • restlessness
  • hallucinations
  • loss of coordination
  • fast heartbeat
  • increased body temperature
  • fast changes in blood pressure
  • overactive reflexes
  • diarrhea
  • coma
  • nausea
  • vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SNRI or a triptan. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Paxil FDA Alert - Antidepressants and Pregnant Women

In July 2006, the FDA issued an alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies had a higher chance (were 6 times as likely) to have PPHN, when compared to babies born to mothers who did not take antidepressants during pregnancy.

The FDA has announced that it plans to further examine the role of SSRIs in babies with PPHN.

Talk to your doctor if you are taking Paxil and are pregnant, or are planning to become pregnant. You and your healthcare professional can decide the best way to treat your depression during pregnancy.

More information on antidepressants is available from the FDA here.

Paxil and Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Paxil-maker GlaxoSmithKline has since added a black box warning to Paxil prescribing information in response to the FDA advisory. Click here for more information on this advisory.

In June 2005, the FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, including Paxil. The FDA advised that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins, and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications. Click here for more information on this advisory.

Most recently, in May 2006 GlaxoSmithKline and the FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the "WARNINGS" section of prescribing information for Paxil and Paxil CR. These labeling changes relate to adult patients, particular those who are younger adults. The results of a recent analysis of Paxil in adult patients showed a higher frequency of suicidal behavior in young adults. However, the FDA states that the results should be interpreted with caution, since the absolute number and incidence of events are small. All reported events of suicidal behavior in adult patients with Major Depressive Disorder (MDD) were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. Click here to read more.

Who Should Not Take Paxil?

Never take Paxil while taking another drug that treats depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking these two drugs close in time can result in serious (and sometimes fatal) reactions including high body temperature, coma, and seizures (convulsions).

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Never take Paxil if you are taking Mellaril (thioridazine), a drug used to treat schizophrenia. Taking Paxil and Mellaril together can cause heartbeat problems.

Paxil Health Risks

Risks of using Paxil include:

  • An increased risk of having suicidal thoughts or actions
  • Bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding
  • Mania (becoming hyperactive, excitable, or elated)
  • Seizures (even if Paxil is not taken close in time with a MAOI)
  • Increased risks if you are pregnant or may become pregnant. Babies born to mothers taking Paxil late in pregnancy have developed problems such as difficulty breathing and feeding
  • Sexual problems including impotence (erectile dysfunction), abnormal ejaculation, difficulty in reaching orgasm, or decreased libido (sexual desire)

Side effects of Paxil use may include:

  • Weakness
  • Dry Mouth
  • Constipation
  • Yawning
  • Infection
  • Diarrhea
  • Sweating
  • Dizziness
  • Tremor
  • Nervousness
  • Nausea
  • Difficulty Sleeping
  • Decreased Appetite
  • Sleepiness

It is important to tell your healthcare professional about all known medical conditions, especially if you have liver or kidney disease, or glaucoma. Tell your doctor if you breast-feed or are planning to breast-feed your baby.

To avoid dangerous interactions with any medicines you might be taking, tell your healthcare professional about all prescription and non-prescription medicines, vitamins, and herbal supplements that you take.

Do not stop taking Paxil suddenly. Doing so may result in harmful side effects. Your healthcare professional should slowly decrease your dose as necessary.

If you plan to drink alcohol while taking Paxil, talk to your healthcare professional.

Paxil - Getting Legal Help

While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions related to Paxil use, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Paxil use.

  • Go here to learn more about an attorney's role in a pharmaceutical liability case.
  • To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.

See also:

  • Why Drugs Get Pulled from the Market
  • Pharmaceutical Product Liability
  • Next Steps
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