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FDA Issues New Paxil Warnings

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The federal Food and Drug Administration (FDA) issued two additional warnings regarding antidepressant drug Paxil in July 2006. The drug, which is prescribed to patients with symptoms of depression and anxiety, has been linked to serious side effects such as persistent pulmonary hypertension syndrome in newborns and SSRI/serotonin syndrome. This follows the drug's linkage with an increased risk of suicide along with other SSRI-type drugs and is the latest in a series of woes for pharmaceutical giant GlaxoSmithKline, which manufacturers Paxil and Paxil CR.

What Is Paxil?

Paxil is the brand name for paroxetine, a serotonin reuptake inhibitor (SSRI). The drug has two variations, Paxil and Paxil CR, in oral suspension and tablet form. Both drugs are used to treat depression, social anxiety disorder (SAD), and panic disorders, with Paxil CR approved for the treatment of premenstrual dysphoric disorder and Paxil approved for use with obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), and post-traumatic stress disorder (PTSD).

Paxil and other SSRIs work by inhibiting the reuptake of serotonin, a hormone essential to balanced brain chemistry. This prevention allows the hormone to stimulate its recipient cell for a longer period of time, "rebalancing" the brain chemistry in depressed patients and restoring normal hormone levels. When they were introduced, SSRIs were hailed as a new generation of antidepressant drugs and are generally characterized as being less dangerous and having fewer side effects than "old-school" antidepressants.

A Multitude of Paxil Side Effects

Though it was greeted with much enthusiasm and is one of the most-prescribed antidepressants on the market, Paxil has been indicated in a number of side effects, some minor, others deadly. These include:

Mania

Some patients who take Paxil experience heightened senses of mania in which they become hyperactive.

Bleeding

Paxil has been linked to bleeding problems, especially when taken in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve) or ibuprofen (Advil).

Sexual Dysfunction

Paxil has been linked to erectile dysfunction (ED), decreased sexual desire, and difficulty reaching orgasm in some patients.

Complications in Pregnancy and Childbirth

A recent study has linked Paxil to a condition known as infant persistent pulmonary hypertension, a condition in which the infant children of mothers who take Paxil get insufficient oxygen in their bodies due to abnormal blood flow. These cases mostly took place in mothers who took Paxil after the 20th week of pregnancy. The infant children of mothers who took SSRI drugs such as Paxil were six times as likely to compared to women who did not take antidepressant drugs during pregnancy. Paxil has also been linked to other problems with pregnancies, including babies with heart problems or who have difficulty feeding or breathing.

Serotonin Syndrome

The FDA recently warned that Paxil and other SSRI drugs are linked with a condition known as serotonin syndrome. Serotonin syndrome usually occurs when patients take Paxil or other SSRIs in conjunction with triptan migraine drugs and is more common when beginning a dose of Paxil or a triptan drug. Serotonin syndrome can cause physical symptoms such as increased body temperature, nausea and vomiting, restlessness, irregular or increased heartbeat, blood pressure changes, coma, and hallucinations.

Increased Risk of Suicide

Perhaps the most serious Paxil side effect is an increased risk of suicide for adult patients. Patients who are taking Paxil have been found to be more likely to think about suicide or actually kill themselves, especially when first beginning their dose or trying to wean off the drug.

If You've Been Affected

If you have suffered from Paxil side effects such as the ones described above, you may be able to recover the costs of your medical care and lost wages by filing a Paxil lawsuit. After obtaining the proper medical care, contact a lawyer experienced in unsafe drugs litigation. Your Paxil attorney can tell you whether you have a claim and help you file suit. A Paxil lawyer may also help you obtain compensation for your side effects, which may include cash payments for pain and suffering, medications and current and future medical costs.


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