Paxil is the brand name of a medicine made by GlaxoSmithKline. Its generic name is paroxetine hydrochloride under the class of Selective Serotonin Reuptake Inhibitors or SSRIs. Paxil was approved by the U.S. Food and Drug Administration (FDA) in 1992. It comes in either oral suspension or tablet form.

What does Paxil treat?

Paxil oral suspension and tablet are generally used to treat or manage the following:

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

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

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

Paxil FDA Alert: Serotonin Syndrome

The FDA, in July 2006, issued an alert to warn the public of the possibility of developing a life-threatening condition known as serotonin syndrome, when Serotonin and Norepinephrine Reuptake Inhibitors or SNRIs are taken together with 5-hydroxytryptamine receptor agonists (triptans) which are generally used to treat a migraine.

The following are the known signs of serotonin syndrome:

• Nausea
• Vomiting
• Restlessness
• Fast heartbeat
• Diarrhea
• Hallucinations
• Overactive reflexes
• Loss of coordination
• Increased body temperature
• Fast changes in blood pressure
• Coma

If you are taking medication for migraine headaches, ask your doctor if what you are taking is a triptan.

Paxil FDA Alert: Antidepressants and Pregnant Women

Another alert was issued by the FDA in July 2006 to inform the public of the results of a study conducted regarding effects of antidepressants on pregnant women and their babies. The study was conducted on the women who gave birth to babies with persistent pulmonary hypertension of the newborn (PPHN). Infants affected with PPHN could get very ill and die. The study showed that there is a higher risk of occurrence of PPHN in infants of mothers who took SSRIs 20 weeks or later into their pregnancy, compared with infants born to mothers who did not take any antidepressant.

Further studies will be conducted by the FDA to look deeper into the effects of SNRI to pregnant women and their babies.

If you are pregnant and taking antidepressants such as Paxil, let your doctor know how your depression can be managed during your pregnancy.

Go to the FDA website to find out more about antidepressants.

Paxil and Increased Risk of Suicidality

Suicidality is the term used for a person’s tendency to be suicidal in thinking and behavior. This is another risk identified by the FDA on those who take Paxil, especially children and adolescents. In October 2004, the FDA warned the public of this, and directed all antidepressant drug manufacturers to change their product labels in order to include a prominent boxed warning, and expanded warning statements to alert the public and health care providers of this risk. GSK complied by adding a black box warning on Paxil packaging.

In June 2005, the FDA issued a similar advisory, citing several recent publications that suggested that adults treated with antidepressants such as Paxil may be at risk for increased suicidal behavior. Adults taking such medications should be watched closely from the moment they start taking the medication.

Who Should Not Take Paxil?

Paxil should never be taken with other medicines for depression like Monoamine Oxidase Inhibitor (MAOI) or if MAOI has been taken within the prior 14 days. There are possible fatal reactions if these drugs are taken together or so closely together. Such risks include high body temperature, seizures, and coma.

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

Paxil should also not be taken with Mellaril (thioridazine) which is used to treat schizophrenia because it may result in heart problems.

Paxil Health Risks

The following is a summarized list of the risks of taking Paxil:

• Mania (becoming hyperactive, excitable, or elated)
• An increased risk of having suicidal thoughts or actions
• 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
• Bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding
• Sexual problems including impotence (erectile dysfunction), abnormal ejaculation, difficulty in reaching orgasm, or decreased libido (sexual desire)

Side effects of Paxil use may include:

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

It is very important to let your doctor know any other medications you are taking, whether prescription, over-the-counter drugs, or health supplements; and medical conditions you may have such as kidney or liver disease or glaucoma. If you are breastfeeding or planning to breastfeed your baby, let your doctor know it.

Also, let your doctor know if you plan to drink alcohol while on Paxil.

However, you should not suddenly stop taking Paxil because there are also risks and harmful side effects to that. Your doctor will be the one to decrease your dosage gradually if needed.

Paxil: Getting Legal Help

It is the manufacturer’s duty to make their product as reasonably safe as possible, and provide the public and medical community with information if there are risks associated with the medicine. Failure to warn the medical community and the public, or even an inadequacy of warning will make the manufacturer liable for any injury caused by their medicine under the product liability theory.

You should go to your doctor or healthcare professional as soon as possible if you or a loved one has experienced any of the dangerous symptoms related to the intake of Paxil. You may also consider consulting with an experienced attorney to find out what your rights and options are, protect your rights, and claim a legal remedy for injuries suffered in relation to the use of Paxil.