The antidepressant medication Cymbalta (duloxetine) has been linked to side effects including severe withdrawal symptoms (Cymbalta Discontinuation Syndrome), suicidal thoughts/suicide, as well as birth defects in babies born to mothers who take the drug during pregnancy.
What is Cymbalta?
Cymbalta is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant prescribed for the treatment of major depressive disorder, generalized anxiety disorder, peripheral neuropathy, diabetic neuropathy, and osteoarthritis pain. The drug is also commonly prescribed to patients suffering from fibromyalgia. Eli Lilly, the company that manufactures Cymbalta, submitted the drug to the FDA for the treatment of stress urinary incontinence; however, the application was denied because of concerns regarding suicidal events and liver toxicity. Duloxetine, the active ingredient contained in Cymbalta, is also marketed under the brand names Duzela, Yentreve, Xeristar, and Ariclaim.
Cymbalta Birth Defects
Expecting mothers suffering from depression and other serious psychological disorders often find themselves having to choose between the lesser of two evils. Should they use an antidepressant like Cymbalta and risk having a child born with major birth defects, or not take the medicine and risk the emotional and hormonal trauma that could also end up harming the baby?
Cymbalta and Heart Defects
Some of the most commonly reported birth defects associated with Cymbalta include atrial septal defects (ASDs) and ventricular septal defects (ASDs). Babies born with these congenital diseases have holes in their septum, the wall that separates the right and left sections of the heart. Holes in the atria (upper filling chambers) or ventricles (lower pumping chambers) allow blood to flow sideways between the chambers of the heart. When this occurs, oxygenated (red) blood from the left side flows through the hole and mixes with oxygen-depleted (blue) blood that then continues to the lungs. Symptoms of Cymbalta-induced septal heart defects may include:
- shortness of breath
- enlarged heart
- high blood pressure
- pulmonary hypertension
- disinterest in feeding, or tiring when feeding
- poor weight gain
- rapid or heavy breathing
- profuse sweating
- frequent reparatory infections
Persistent Pulmonary Hypertension of the Newborn
Since at least 2006, Cymbalta has been linked to persistent pulmonary hypertension of the newborn (PPHN). A study published that year in the New England Journal of Medicine determined that babies born to mothers who used antidepressants like Cymbalta while pregnant were 6 times more likely to have PPHN than children born to mothers who took no such antidepressants during pregnancy. Then in January 2012, another study published in the British Medical Journal found that antidepressant use during pregnancy had been associated with a doubled risk of having a child born with PPHN. The findings of the study increased the absolute risk of PPHN from 1.2 to 3 cases per 1,000 live births. Symptoms of Cymbalta-induced persistent pulmonary hypertension of the newborn include:
- rapid breathing (tachypnea)
- rapid heart rate
- respiratory distress
- flaring nostrils
- cyanosis (bluish tint to the skin)
- heart murmur
- low oxygen levels
Cymbalta and Suicide
In addition to having the potential to cause the above-listed birth defects in babies born to mothers who take the drug during pregnancy, Cymbalta has also recently been linked to suicidal thoughts and suicidal ideation in certain users. After the FDA approved Cymbalta in 2004, it required that the drug carry a “Black Box Warning” which stated that suicidal thoughts and changes had been reported in children and teenagers who took antidepressants like Cymbalta.
Cymbalta may cause severe withdrawal symptoms in some patients when they quit taking the drug. Clinically referred to as “Cymbalta Discontinuation Syndrome”, symptoms of this condition include:
- Blurry vision
- Paresthesia (“brain zaps”, or electric shock sensations in the brain)
These symptoms are often so severe that patients must continue taking Cymbalta simply to lessen the effects of the withdrawal. This results in leaving the patient totally dependent on the drug. Lawsuits allege that Eli Lilly & Co. misled consumers about the incidence of Cymbalta Withdrawal, claiming that the side effect occurs in about 1% of patients, when the actual percentage of users who experience it is between 44% and 78%.