Generic: Paroxetine HCI
Date approved: 1992
Status: Prescription only
Approved uses: Treatment of depression, obsessive compulsive disorder (OCD), panic disorder, and social anxiety disorder
Off-Label uses: Treatment of depression symptoms in children
• Homicidal and suicidal tendencies
• difficult withdrawal with marked dependency symptoms
• psychological symptoms including anxiety attacks and mood swings
• A marked risk of suicidal thoughts and suicide attempts has been noted in children under 18.
Related topics: Unsafe drugs
Paxil (paroxetine) is a SSRI (selective serotonin reuptake inhibitor) manufactured by GlaxoSmithKline and used in the treatment of depression. Paxil and other SSRIs have been implicated in a heightened risk of suicide for depressed patients and the FDA recently recommended that the drug not be prescribed for children under the age of 18. Other Paxil side effects include weight gain, dependency symptoms and difficult withdrawal, and other psychological symptoms including panic attacks, anxiety and aggressiveness. Paxil should not be used in pregnant women, as it has been linked to birth defects.
FDA Issues New Paxil Warnings
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:
Some patients who take Paxil experience heightened senses of mania in which they become hyperactive.
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).
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.
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.
Paxil Linked To Dangerous Withdrawal Symptoms
Popular serotonin reuptake inhibitor (SSRI) antidepressant drug Paxil has been linked to SSRI Discontinuation Syndrome, a severe and sometimes life-threatening condition that occurs upon withdrawal from the drug. This is just one of many recent Paxil side effects, such as complications in pregnancy, increased risk of suicide and serotonin syndrome, that have brought the drug and its manufacturer, GlaxoSmithKline, under fire.
What is SSRI Discontinuation Syndrome?
SSRI Discontinuation Syndrome occurs within 24 hours to one week of cessation of Paxil or similar SSRI drugs. The syndrome is connected to a drug’s “elimination half-life”, the period of time necessary before a pharmaceutical agent is completely out of a patient’s system. Paxil has a particularly long half-life and a higher incidence rate of SSRI Discontinuation Syndrome. While SSRIs like Paxil have been touted as non-addictive, the withdrawal syndrome mimics some typical facets of withdrawal from addictive drugs such as alcohol or opiates and creates powerful symptoms including:
• Gastrointestinal disturbances, including nausea or diarrhea;
• Mood disorders, such as suicidal ideation (suicidal thoughts), tearfulness, mania, irritability and aggression;
• Sensory and movement disorders, such as vertigo, trembling, dizziness, tingling and numbness, difficulty moving or walking, and ringing of the ears (tinnitus); and
• Sleep disorders, such as fatigue, narcolepsy, insomnia or vivid dreams.
Since the withdrawal symptoms of Paxil can be so strong, patients are encouraged to speak with their health care provider before going off the drug and are advised not to stop the drug suddenly. An experienced Paxil doctor can help you ramp down your dosage in appropriate amounts, tapering the dose off until you are no longer on the drug; however, Paxil tapering has not been proven to prevent the symptoms of SSRI Discontinuation Syndrome.