FDA Rides the Fence Regarding Celexa Side Effects
By Andrea Gressman
It has been common knowledge that the FDA’s position on medications, including SSRI antidepressants, is that they are okay for patients to use as long as the benefits outweigh the side effect risks that the drug may cause. Of course, that is a point of heated debate by many, including a number of Celexa lawsuits.
Celexa Linked to Heart Defects in Children and Adults
Recently, the Food and Drug Administration was compelled to provide updates to the Celexa label. The Celexa labels are to now mention the side effect risk of developing congenital long QT syndrome, a Celexa birth defect that has been reported by many people. The label update was issued in March of 2012. However, in August of 2011 the FDA did require Celexa to revise their warning label to specifically emphasis the side effect risk involving heart conditions in older patients when taking a dose in a higher quantity.
The August 2011 label update was a result of a study regarding patients who were taking 60mg of Celexa on a daily basis and as a result of taking that dosage it resulted in a higher risk of abnormal cardiac electrical activity. So, just a few months later the FDA was readdressing the Celexa label and suggesting that the safe dosage of Celexa is 20mg each day for any patient over the age of 60 years of age.
However, the major concern for Celexa is actually its link to birth defects. Several studies have been completed that seem to establish that the birth defects are a side effect directly linked to Celexa. It is important to note that the dosage of Celexa was higher than normal in these studies. However, the FDA is evidently unsatisfied with the results of these studies when it comes to conclusively showing that Celexa does cause birth defects if taken during pregnancy.
It has also been found that Celexa can negatively impact a mother’s breast milk. It can affect the baby in a negative way by causing weight loss as well as sleepiness. The FDA gave Celexa a “C” rating when it comes to the Pregnancy Category. The FDA indicated that this was because they do not have any controlled studies that show the birth defects exist in humans and that the animal studies were not sufficient for them to make an adjustment in their evaluation. Therefore, they have made the recommendation that Celexa should only be used during pregnancy if absolutely necessary.
Many feel that this is just the FDA riding the fence when it comes to Celexa’s actual side effect risk of causing birth defects if taken during pregnancy. Because of this, many feel that more babies will unnecessarily be exposed to the side effects of Celexa and as a result more Celexa birth defect lawsuits will most likely be filed so that the families can receive compensation for the birth defects Celexa has been established in causing.
If your child was born with a birth defect because of taking Celexa during pregnancy, contact a Celexa birth defect attorney right away. Visit the Zoloft, Paxil, Celexa, Lexapro & Prozac SSRI Antidepressant Birth Defect Class Action Lawsuit Investigation page to receive your free consultation regarding your child‘s birth defect.
Updated November 9th, 2012
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