Cymbalta Birth Defects and Withdrawal Symptoms

Cymbalta (duloxetine) is in a class of drugs known as SNRIs (Selective Serotonin/Norepinephrine Reuptake Inhibitors), similar to SSRIs. It is an antidepressant used to treat depression and anxiety. It is also used to manage osteoarthritis, fibromyalgia, and other painful conditions. Cymbalta side effects include severe psychiatric problems such as suicidal thoughts and birth defects in the newborn when taken by the mother during pregnancy (Although the drug has a black box warning about suicidal thoughts, Cymbalta Suicide Lawsuits have been filed). A number of people experiencing severe Cymbalta Withdrawal symptoms have filed Cymbalta Withdrawal lawsuits.

Dozens of people nationwide have filed Cymbalta Withdrawal lawsuits against Eli Lilly & Co., claiming withdrawal symptoms were so severe that they were unable to discontinue the drug. The lawsuits allege the drug manufacturer failed to warn about the risk of severe withdrawal symptoms, including "brain zaps". One lawsuit claims that the prescribing information on Cymbalta is deficient because it warned that the amount of patients experiencing withdrawal are "greater than or equal to 1 percent". However, studies have found that 50 percent of patients experience withdrawal and 10 percent of those patients experience severe Cymbalta withdrawal symptoms.

The Institute for Safe Medication Practices (ISMP) in October 2012 investigated results of clinical studies. The non-profit healthcare consumer safety watchdog found that "withdrawal symptoms were reported in 44-50% of patients abruptly discontinuing duloxetine [Cymbalta] at the end of clinical studies for depression, and more than half of this total did not resolve within a week or two."The clinical trial was required by the FDA to investigate withdrawal from Cymbalta but the participant/patients only took the drug for 8-9 weeks before they were switched to a placebo and then monitored for just 1-2 weeks. Although the clinical trial lasted two months, many people take Cymbalta for years.

The French Medical Journal ( Prescrire) in 2009 published findings of a study that concluded Cymbalta risks outweighed its benefits. Another report by QuarterWatch in 2012 reviewed 48 FDA event reports of serious withdrawal symptoms, from appetite changes and blackouts to suicidal thoughts. It found that many of those 48 cases required hospitalization.

A common Cymbalta (generic name Duloxetine hydrochloride) withdrawal complaint is "brain zap", which patients describe as a sudden electric-like shock through the brain which result in debilitating headaches and bouts of nausea and dizziness. Health professionals believe it may be a form of paresthesia— an abnormal sensation of the body, such as numbness, tingling, or burning. Other severe Cymbalta side effects after discontinuing use include neurological problems and mood swings, which can lead to suicidal thoughts.

Eli Lilly & Co. in January, 2013 asked a federal judge in California to throw out a Cymbalta class action, according to Law360 (Case 2:12-cv-09366-SVW-MAN). Plaintiffs Jennifer L. Saavedra, Dr. Melissa Strafford, Carol Jacquez, and David Matthews allege that "Lilly has failed to disclose material facts to consumers and healthcare professionals about the frequency, severity, and/or duration of symptoms associated with stopping Cymbalta, a condition known as Cymbalta withdrawal."

In November, 2014 Eli Lilly & Co was awarded summary judgment in a Cymbalta lawsuit. Plaintiff Jesse McDowell argued that the Prescribing Information on Cymbalta was deficient because it only warned that "greater than or equal to 1%"of patients experience withdrawal. U.S. District Judge Robert W. Sweet, however, decided that Eli Lilly adequately warned about the risk of severe withdrawal symptoms. According to Law360.com, thedecision could diminish the chances of federal judges consolidating dozens of similar lawsuits in a federal Multi-District Litigation (MDL).

In 2013, seven Cymbalta withdrawal personal injury cases were filed across the country (Arizona, California, New York and Pennsylvania). In August of 2014, more Cymbalta withdrawal cases were filed in California, Florida, Georgia, Louisiana, Maryland, Minnesota, Ohio, Oregon, North Carolina, Pennsylvania, and Wisconsin. Cymbalta consumers claim that the drug maker misled them regarding Cymbalta' propensity to induce withdrawal side effects and forced them to keep taking the drug.

SSRIs have been linked to serious side effects including heart defects and persistant pulmonary hypertension in the newborn (PPHN) when taken by the mothers during pregnancy.

In July of 2006, the FDA issued a Health Advisory advising people of serious side effects if taking SNRI/SSRIs while pregnant. The New England Journal of Medicine published a study that showed mothers who took SNRIs such as Cymbalta during the second half of their pregnancy were six times more likely to have a baby with PPHN or heart defects.

An infant with PPHN suffers from constricted blood vessels in the lungs, preventing blood from being enriched with oxygen. During pregnancy, the baby's circulation is controlled by the placenta and the lungs are not used. After birth, however, circulation switches to the lungs and the ductus arteriosus then closes. In babies with PPHN the ductus arteriosus remains open, causing blood flow to continue bypassing the lungs.

The blood therefore does not enter the lungs, and is pumped back to the other organs of the body very low in oxygen. Without oxygen, the organs go into stress and put the infant's life at risk.

Persistant Pulmonary Hypertension in the Newborn is usually diagnosed within 12 hours of birth. Even if they are treated, babies may experience heart failure, brain hemorrhage, seizures, and organ damage. Ten to 20 percent of newborns who develop PPHN do not survive.

Babies with PPHN experience difficulty in breathing and bluish skin and may suffer long-term side effects including difficulty breathing, hearing loss, seizures, and developmental disorders.

PPHN occurs naturally in about one or two infants per 1,000 births, but if the baby is exposed to SSRIs during the second half of pregnancy the rate jumps to six to twelve infants per 1,000 births that developed PPHN.

Babies exposed to Cymbalta during gestation also suffer withdrawal symptoms such as incessant crying, agitation and sleeplessness. Cymbalta can also be transmitted to an infant being breast-fed.

Eli Lilly, makers of Cymbalta, have allegedly failed to adequately warn users that birth defects are a possible side effect of taking Cymbalta during pregnancy. Please contact a lawyer who may be able to help you gain restitution if your child was born with birth defects after being exposed to Cymbalta during pregnancy.

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Last updated on Dec-25-14