Pregnancy, Prozac, and the Patent: What You Need to Know About This Risky Drug

Since the 1980s, many have turned to medications such as Prozac to combat their depression. However, those who are pregnant or attempting to get pregnant need to think again before taking these drugs. In fact, Prozac, when taken during pregnancy, has resulted in many birth defects, some of which include limb defects, craniosynostosis, anal atresia, persistent pulmonary hypertension of the newborn (PPHN), omphalocele, heart defects, and neural tube birth defects. On July 19, 2006, the FDA released a warning that SSRI antidepressants can cause serious or life-threatening lung problems in newborns whose mothers took the medication while pregnant. The warning came after a study was published in the New England Journal of Medicine that showed infants were six times more likely to suffer Persistent Pulmonary Hypertension in the Newborn (PPHN) after being exposed to SSRIs, the class of drugs that includes Prozac, Paxil, Celexa, Effexor, Lexapro, Pristiq, and Zoloft. Babies whose mothers took Prozac and other antidepressant drugs in this class while pregnant may also suffer withdrawal symptoms such as agitation, poor feeding, and insomnia. Prozac (also known as fluoxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Prozac affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms. In the early 1970s, evidence of the role of serotonin in depression began to emerge, and the hypothesis that enhancing 5-HT neurotransmission would be a helpful way to combat depression was put forward. On the basis of this hypothesis, efforts to develop agents that inhibit the uptake of 5-HT were initiated. These studies led to the discovery and development of Prozac, which was approved for the treatment of depression by the FDA in 1987. Prozac has been manufactured and marketed by Eli Lilly & Company, which is based in Indianapolis, Indiana. However, on August 2, 2011, Lily's patent for this profitable drug expired. This has resulted in an estimated loss of $2.4 billion in annual sales for Lilly. The patent was invalidated after a lengthy legal battle waged by a small, aggressive generic-drug company called Barr Laboratories. The loss of this patent lawsuit by Lilly will allow other companies that want to sell the drug to be able to do so. Now, a 20-milligram capsule that presently retails for $2.50 likely will fall to less than 25 cents per capsule. This will significantly affect Lilly's revenues, which were reported during the 2010 fiscal year to be $23 billion in total sales and $5 billion in net income. Since it was launched in early 1988, Prozac has been one of the biggest-selling drugs in history; its $21 billion in sales represents about 30% of Lilly's revenues in that period. Lilly is also the manufacturer of other well-known psychiatric drugs, including Cymbalta and Zyprexa. It is unclear at this time how this change in the patent protection for Prozac will affect some of the pending and upcoming litigation being filed on behalf of children who have suffered devastating birth defects as a result of their mother's ingestion of this drug during the first trimester of their pregnancies. Nonetheless, the drug is still being prescribed and children are still being born with birth defects. It is important that patients obtain the facts about antidepressants and use of the drugs during pregnancy. It is also important that patients understand what remains unknown about the potential safety risks that Prozac and other drugs pose to a developing fetus, facts that would be shocking to most patients especially since the drugs have been marketed for more than 20 years! Most importantly, speak with your doctor before doing anything, especially before getting off the medication, as it is very important that patients be properly weaned from antidepressants and that other supportive therapy be administered to manage the depression.

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