Prozac side effects can include an increased risk of birth defects if taken by mothers during pregnancy. We are working with experienced dangerous drug attorneys across the country, who can file a Prozac lawsuit on your behalf and charge no legal fees until you obtain a settlement or award. Feel free to contact us online or toll free at 1-800-992-6878 for your free legal consultation.
Prozac (fluoxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant used to treat conditions such as depression, obsessive-compulsive disorder, and panic disorders. The drug received FDA approval in December 1987 and its patent later expired in August of 2001. Since entering the market the antidepressant has generated huge sales numbers for its manufacturer, Eli Lilly and Company. By 2001, the medication was being used by 40 million people and its total sales surpassed $21 billion (i). However, in that same year, the patent expired and there was steep decline in the drug’s sales figures. The decline in sales combined with an increasing number of Prozac birth defect lawsuits has been problematic for the drug’s manufacturer in recent years.
Prozac Side Effects
This antidepressant has been on the market for a longer period of time than most others; therefore there are a substantial number of FDA adverse event reports and medical studies addressing its side effects. In fact, the FDA has received over 10,000 adverse event reports detailing instances where the drug was determined to be the primary suspect in causing the serious adverse event (ii). The most common side effects of this medication are relatively minor as they include: drowsiness, weight changes, cold-like symptoms, and nausea. However, this drug has caused serious adverse events such as: birth defects, serotonin syndrome, suicidal thoughts, or violent outbursts.
Prozac Birth Defects
Prozac is included in the SSRI antidepressant group; a class of medications which medical studies have linked with an increased risk of certain birth defects. Concerns about birth defects have caused the FDA to include the drug in pregnancy category C. This means that the drug may affect the fetal development but no conclusive link has been established by human trials (iii). Medical decisions involving pregnant women are complex because taking any type of medicine affects both the mother and the fetus. Medical decisions involving antidepressants and pregnant women can be even more challenging because some antidepressants can increase the risk of birth defects, but discontinuing use of the drug can result in withdrawal symptoms. The primary birth defect the FDA has warned about as being associated with use of this drug is primary pulmonary hypertension (PPHN). In July 2006, the agency announced that a medical study revealed “infants born to mothers who took [SSRIs] after the 20th week of pregnancy were 6 times more likely to have [PPHN] than infants born to mothers who did not take antidepressants during pregnancy.” The study sampled the birthing outcomes of 1,213 women over a 5-year period (iv).
Mothers who use SSRIs such as this one during pregnancy risk giving birth to a child who suffers from:
- Abdominal birth defects
- Cleft lip or palate
- Down’s syndrome
- Hypoplastic Left/Right Heart Syndrome
- Persistent Pulmonary Hypertension (PPHN)
- Septal heart defects (atrial or ventricular)
- Spina bifida
- Or any other birth defects
In July 2006, the FDA warned that SSRI antidepressants could cause serotonin syndrome when taken with migraine medicines using triptan. This condition may result because SSRIs and triptans can both raise serotonin levels on their own and the combination of the two drugs can be life-threatening. Signs of serotonin syndrome include rapid heart rate, nausea, as well as hallucinations. Serious cases of this condition may result in coma and can even be life-threatening (v).
Prozac Suicide and Violence Risks
In October 2004, an FDA alert stated this medication was one of several antidepressant drugs that could increase the risk of suicidal thoughts in children and teenagers. The FDA determined that all antidepressant manufacturers should expand their labels to reflect this serious risk. The FDA alert was based on 24 studies involving over 4,400 patients. Subsequent medical studies caused the FDA to expand the label changes further to warn that the increased risk of suicidal thoughts could affect patients up to the age of 24 (vi). In addition to suicidal thoughts, this drug may increase the risk of aggressive and violent thoughts. Some studies have suggested a link between the medication and aggressive behavior. Additionally, there are countless news stories of people taking this antidepressant and acting violently. Some researchers have argued however, that any aggressive behavior displayed by a patient taking the medication is a product of the underlying condition, not use of the drug itself (vii).
About the Manufacturer and Prozac Lawsuits
Eli Lilly is currently facing a number of lawsuits centered on this drug. In fact, the company’s 2012 annual report stated: “[w]e are subject to a substantial number of product liability claims involving primarily Byetta, Zyprexa, diesthylstilbestrol (DES), Darvon, and Prozac.” In the same report, the company stated it had been named as a defendant in 7 Prozac lawsuits and that there were at least 340 additional outstanding claims pursuant to the drug that had not yet been filed (viii). In 1999, Eli Lilly was engaged in a Prozac patent dispute with generic drug manufacturers which settled for $4 million. According to one news source, in 2000, Eli Lilly settled 30 Prozac suicide lawsuits for approximately $50 million (ix).
Contact the Law Offices of d’Oliveira & Associates, P.C.
If you are a mother who took this antidepressant during pregnancy and gave birth to a child with Prozac birth defects, you may have a potential legal claim. Our firm works with experienced dangerous drug attorneys, who can help you pursue your Prozac lawsuit by filing a claim on your behalf.
Contact d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.
- (i) Bloomberg Businessweek, July 2001.
- (i) CNN Money, August 2001.
- (ii) Adverse Events, August 2012.
- (iii) Code of Federal Regulations, Title 21, Chapter I, Subchapter C, Part 201.
- (iv) FDA Public Health Advisory, July 2006.
- (v) FDA Public Health Advisory, July 2006.
- (vi) FDA Consumer Update, January 2009.
- (vii) CNN Article, February 2008.
- (viii) Pfizer 2012 Annual Report.
- (ix) Boston Globe, November 2000.