In recent months the FDA has been compelled to update the label of the Selective Serotonin Reuptake Inhibitor to reflect potential issues in patients suffering from congenital long QT syndrome. That was in March. Meanwhile, it was a year ago this month that the FDA required a revision of the Celexa label with particular emphasis on Celexa side effects involving the heart—specifically, when Celexa was taken at a higher dose.
The now year-old label change was fostered from the results of a study that found patients taking 60 mg of Celexa daily presented with a higher risk of having issues involving abnormal cardiac electrical activity. Seven months later the FDA was back, suggesting a maximum dose of 20 mg per day for patients over the age of 60.
The potential headline that causes the most concern, however, is 'Celexa Linked to Birth Defects.' Various studies have determined that such defects are possible, although at doses higher than what would normally be seen in the everyday world. And while Celexa secreted through breast milk can impact an infant to the point of causing excessive sleepiness or weight loss, the FDA has given Celexa a Pregnancy Category 'C' rating, which can be interpreted as a fence-sitter. The FDA notes that while birth defects have been shown in animals, a lack of controlled studies on humans gives the FDA pause to simply recommend Celexa be used during pregnancy only if the benefits outweigh the risks for both mother and fetus.
That, in spite of new research suggesting a link between use of SSRI antidepressants such as Celexa and premature birth.
For now, the FDA is satisfied that the risk / benefit profile of Celexa and any potential for Celexa birth defects, can best be handled by the patient and her doctor. In sum, the FDA maintains it is acceptable to use Celexa, as labeled, so long as the benefits outweigh the risks. But the FDA is deferring that decision, to the patient-doctor relationship.
In an unrelated issue, it was reported in June that the state of Idaho would be receiving almost $800,000 from Forest Laboratories Inc., the manufacturer of Celexa, stemming from the state's claim that Forest overcharged Idaho's Medicaid program. According to The Idaho Statesman (6/8/12) the state Attorney General's office accused the company of inflating, or falsifying the price for product used by Medicaid administrators to reimburse pharmacies for drugs.
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The payments are broken down as follows: about $461,000 for Medicaid, $185,000 to the state's general fund, and $50,000 to the office of the Attorney General for investigative and legal costs, including a Celexa attorney. It should be noted that the action of Forest is not isolated. Wasden is pursuing similar settlements from 29 other manufacturers for related pricing offences.