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).

For more on paxil cases, please follow this link.


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