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Paxil FAQs

Q: What is Paxil?

A: Paxil (paroxetine hydrochloride) is in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil tablets and oral suspension are used to treat depression, panic disorder, social anxiety disorder (SAD), obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and generalized anxiety disorder (GAD).

Paxil is made by GlaxoSmithKline and was approved by the U.S. Food and Drug Administration (FDA) in 1992.

Q: What is Paxil CR?

A: Paxil CR (controlled-release tablets) is a different formulation of Paxil. Paxil CR is used to treat depression, panic disorder, social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD).

Q: Has there been any recent news about Paxil?

A: Over the last few years, the FDA has worked closely with manufacturers of all marketed antidepressants (including Paxil) to fully evaluate the risk of suicidality in children, adolescents, and adults treated with these medications. Paxil maker GlaxoSmithKline added a black box warning to Paxil prescribing information describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants.

More 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.

In July 2006, the FDA issued two alerts related to Paxil. The first FDA alert announced the results of a study concerning the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

The second FDA alert states that a life-threatening condition called serotonin syndrome can occur when SSRIs (such as Paxil) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together.

Q: Who should not take Paxil?

A: 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).

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

Q: Are there any serious health risks associated with Paxil?

A: Harmful side effects may occur if you stop taking Paxil suddenly. Your healthcare professional should slowly decrease your dose as necessary. Other risks include an increased risk of having suicidal thoughts or actions, bleeding problems, mania, seizures, and sexual problems. There are also increased risks if you take Paxil while you are or may become pregnant.

Q: Are there any side effects associated with Paxil?

A: Some side effects associated with Paxil use include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite, and sleepiness.

Q: What should I tell my healthcare professional before he or she prescribes Paxil?

A: 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 healthcare professional if you breast-feed or plan to breast-feed your baby; about all prescription and non-prescription medicines, vitamins, and herbal supplements that you take; and if you plan to drink alcohol while taking Paxil.

Q: What should I do if I think I have been injured as a result of taking Paxil?

A: If you have experienced any dangerous symptoms or your child has suffered a birth injury that may be related to Paxil use, you should first contact your doctor or other healthcare professional. Once you've talked to your doctor, it's in your best interests to have your claim reviewed by a product liability attorney as soon as possible to discuss your options and to protect your right to a legal remedy for any injuries. Under product liability law, drug manufacturers have a duty to ensure that the medications they place on the market are free from any dangerous defects. By failing to do so, manufacturers can expose themselves to liability.

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