Paxil is a brand name for paroxetine, a prescription drug most commonly prescribed for depression or anxiety disorders. Paxil is a Selective Serotonin Reuptake Inhibitor (SSRI) manufactured by GlaxoSmithKline. It was approved by the U.S. Food and Drug Administration (FDA) in 1992. Paxil is used to treat:
- Panic disorder
- Social anxiety disorder (SAD)
- Obsessive-compulsive disorder (OCD)
- Posttraumatic stress disorder (PTSD)
- Generalized anxiety disorder (GAD)
- 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:
- Loss of coordination
- Fast heartbeat
- Increased body temperature
- Fast changes in blood pressure
- Overactive reflexes
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 receive enough oxygen to their bodies. Babies with PPHN can be very sick and may die.
The study also reported that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies were 6 times as likely to have PPHN than babies born to mothers who hadn’t taken antidepressants during pregnancy. 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.
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.
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.
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.
Who Shouldn’t 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
The 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:
- Dry Mouth
- Difficulty Sleeping
- Decreased Appetite
It’s 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.
Don’t 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
Nearly all medications carry side effects. However, drug manufacturers have a legal duty to make their products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with their drugs. If a manufacturer fails to do so, it can be held legally responsible for any injuries that result from inadequate warnings or the unreasonably dangerous nature of the drug. These types of lawsuits are generally brought under a legal theory known as "product liability."
If you or a loved one has experienced any dangerous symptoms or unusual medical conditions related to Paxil use, you should first contact your doctor or other healthcare professional. It’s also in your best interests to consult with a product liability attorney to learn more about your legal options.