Pharmaceutical Drug Injury: Paxil

Paxil


Atrial (ASD) & Ventricular Septal Defects (VSD) :: PPHN

Paxil (paroxetine hydrochloride), manufactured by GlaxoSmithKline, was marketed beginning in 1987 as a selective serotonin reuptake inhibitors (SSRI/SSRIs) medication designed to relieve:

  • Depression
  • anxiety disorders
  • bulimia nervosa
  • alcoholism
  • borderline personality disorder
  • post-traumatic stress disorder (PTSD)
  • obesity

The National Institute of Mental Health characterizes an SSRI/SSRIs as a mental health medication. For more information on mental health medications (e.g. SSRI/SSRIs and SNRI/SNRIs) from the NIMH, click here.

SSRI HEALTH RISKS

An SSRI/SSRIs is an antidepressants. However, when taken by an expectant mother during pregnancy, SSRIs may pose significant side effects and/or health dangers for another, unknowing victim: the unborn fetus.

Studies have linked the use of SSRI/SSRIs during pregnancy with an increased of heart congenital defects (risk birth injury defects) - heart valve defects, atrial (ASD) and ventricular septal defects (VSD) (holes in the walls of the chambers of the heart) - in newborns when Paxil is taken during the first three months of pregnancy and persistent pulmonary hypertension of the newborn (PPHN), a life-threatening respiratory condition that affects a baby's ability to breathe after birth.

In addition, a life-threatening condition called serotonin syndrome can happen when medicines called selective serotonin reuptake inhibitors (SSRI/SSRIs), such as Paxil, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together.

SSRIs IN ACTION

Research suggests that problems with neurotransmitter activity in the brain can negatively affect a person's moods and behavior. It appears that low levels of the neurotransmitters serotonin and norepinephrine have been linked to depression and other mood disorders.

SSRI/SSRIs are believed to work by blocking the reabsorption, or reuptake, of serotonin by certain nerve cells in the brain.

Therefore, serotonin should become more available and enhance the transmission of chemicals in the brain and improve overall mood. SSRIs are called "selective" due to the fact that they appear to only affect serotonin, not other neurotransmitters.

Side Effects of SSRIs

In general, symptoms and/or side effects may include:

  • Increased sweating
  • Weight gain
  • diarrhea
  • Loss of appetite
  • nervousness
  • rash
  • agitation
  • tachycardia
  • restlessness
  • drowsiness
  • insomnia
  • nausea
  • sexual dsyfunction
  • headache

Since every SSRI/SSRIs has its own unique chemical makeup, individual patients may respond differently to a single SSRI. In the same token, each patient may experience varied side effects with different types of SSRIs.

OTHER SSRI MEDICATIONS

  • Prozac (Fluoxetine)
  • Zoloft (sertraline hydrochloride), manufactured by Pfizer, Inc.
  • Luvox (fluvoxamine maleate), manufactured by Solvay Pharmaceuticals.
  • Celexa (citalopram hydrobromide), manufactured by Forest Pharmaceuticals, Inc.
  • Lexapro

FDA ALERTS

Persistent Pulmonary Hypertension (PPHN) [issued 7/2006]

The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious respiratory condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal.

Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.

The study results showed that babies born to mothers who took Paxil - a selective serontonin reuptake inhibitors (SSRIs) in weeks 20 or later in their pregnancies, had a higher chance of developing persistent pulmonary hypertension of newborn (PPHN).

Triptan and Serotonin Syndrome [issued 7/2006]

A life-threatening condition called serotonin syndrome (serious changes in how your brain, muscles and digestive system work due to high levels of serotonin in the body) can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as Paxil, and medicines used to treat migraine headaches (triptans), are used together. Signs and symptoms of serotonin syndrome include the following:

  • restlessness
  • diarrhea
  • hallucinations
  • coma
  • loss of coordination
  • nausea
  • fast heart beat
  • vomiting
  • increased body temperature
  • fast changes in blood pressure
  • overactive reflexes

Heart defects [Issued 12/2005]

On December 8, 2005, the Food and Drug Administration released results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for long term birth defects, particularly congenital heart defects, when women take it during the first three months of pregnancy.

Apparently, Paxil may cause heart defects - atrial (ASD) and ventricular septal defects (VSD) (holes in the walls of the chambers of the heart) - in newborns when Paxil is taken during the first three months of pregnancy (birth injury defects).

Congenital Heart Defects - NCBI

  • Atrial septal defect (ASD) - An ASD is a hole in the part of the septum that separates the atria—the upper chambers of the heart.
  • Ventricular septal defect (VSD) - A VSD is a hole in the part of the septum that separates the ventricles—the lower chambers of the heart.
  • Narrowed Valves - Some congenital heart defects also can involve the heart's valves. These valves control the flow of blood from the atria to the ventricles and from the ventricles into the two large arteries connected to the heart (the aorta and the pulmonary artery). Valves can have the following types of defects:
    * Stenosis (ste-NO-sis). This defect occurs if the flaps of a valve thicken, stiffen, or fuse together. This prevents the valve from fully opening. The heart has to work harder to pump blood through the valve.
    * Atresia (a-TRE-ze-AH). [This defect occurs if a valve doesn't form correctly and lacks a hole for blood to pass through. Atresia of a valve generally results in more complex congenital heart disease.]
    * Regurgitation (re-GUR-ji-TA-shun). [This is when the valve doesn't close completely, so blood leaks back through the valve.]
  • Tetralogy of Fallot (teh-TRAL-o-je of fah-LO), (the most common complex heart defect), is a combination of four defects:
    * Pulmonary valve stenosis
    * A large VSD
    * An overriding aorta. [In this defect, the aorta sits above both the left and right ventricles over the VSD, rather than just over the left ventricle. As a result, oxygen-poor blood from the right ventricle can flow directly into the aorta instead of into the pulmonary artery to the lungs]
    * Right ventricular hypertrophy. [In this defect, the muscle of the right ventricle is thicker than usual because of having to work harder than normal.]

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