Mothers who took Pristiq during pregnancy may give birth to children who suffer serious birth defects like persistent pulmonary hypertension (PPHN), septal heart defects, or other malformations. Our law firm is working with some the more experienced dangerous drug lawyers in the country, who can file a Pristiq lawsuit on your behalf and charge no legal fees until you receive a settlement or award. Contact us for a free consultation either online or by calling our toll free number at 1-800-992-6878.
Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant. This drug treats depression by regulating the levels of serotonin and norepinephrine in the brain. In February 2008, the FDA approved this medication for sale on the market by Wyeth, which was later acquired by Pfizer. The drug is very similar to Effexor, another antidepressant originally manufactured by Wyeth. The product’s sales have grown steadily and Pfizer recorded sales of $466 million in 2010, $577 million in 2011, and $630 million in 2012 (i). In the coming years, Pfizer does not have to worry about generic versions of the drug because its patent will remain valid until 2022.
Pristiq Side Effects
The most common side effects associated with this antidepressant are dizziness, sweating, decreased appetite, constipation, and nausea. The drug has been linked to more serious side effects however, including: birth defects, suicidal thinking, and withdrawal symptoms.
Pristiq Birth Defects
An increasing number of studies have suggested that antidepressants, specifically those that regulate serotonin, are linked to birth defects. In fact, the FDA has included Pristiq in pregnancy category C. This means that animal testing has suggested the drug may have an adverse effect on the development of a fetus but there have not yet been adequate human trials (ii). However, a number of post-market studies have been directed at the use of serotonin drugs in pregnant women. In February 2006, New England Journal of Medicine published a study which found that 14 newborns in the serotonin drug group had persistent pulmonary hypertension (PPHN), whereas only 6 newborns in the control group had PPHN. The doctors who conducted the study stated that the data “support[ed] an association between the maternal use of SSRIs in late pregnancy and PPHN in the offspring (iii).” In June 2007, the same journal published another study which found that “[a]ssociations were observed between SSRI use and three types of birth defects.” These serotonin birth defects were anencephaly (malformation of the skull), craniosynostosis (abnormal skull development), and omphalocele (growth of intestines or other organs outside of the body) (iv).
Pristiq birth defects may include the following:
- 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
Pristiq Suicide Risks
According to CBS News, this particular antidepressant contributed to 17 completed suicides within its first two years on the market (v). Such reports, combined with the rapid growth of the antidepressant market have caused the FDA to issue warnings about all antidepressant medications. For example, in October 2004, the FDA required all antidepressant manufacturers to add a black box to the label warning about an increased risk of suicidal tendencies in children and teenagers who take antidepressants. Later, in May 2007, the FDA expanded the scope of its warning to include young adults up to the age of 24 (vi). The FDA label changes highlight the seriousness of depression as a condition. Antidepressant manufacturers and prescribing physicians have a duty to inform patients about the drugs that are being used to treat this serious condition.
Pristiq Withdrawal Symptoms
Effexor (venlafaxine) was the predecessor to Pristiq, and was linked to serious withdrawal symptoms. Pristiq is a metabolite of Effexor, which means that it is merely an altered form of Effexor and has the same active ingredient, venlafaxine. Some patients taking this medication have reported withdrawal symptoms similar to Effexor but studies have not yet examined the frequency or severity of the side effects that result from discontinuing use.
Lawsuits Against the Manufacturer
Pristiq has caused Wyeth and Pfizer to face several legal issues. In November 2012, Pfizer announced that it settled a shareholder class-action lawsuit for $67.5 million. The shareholders sued because the company inflated stock prices by misrepresenting the uses of the antidepressant. The company projected it would earn $2 billion in sales once it was approved for treatment of menopause symptoms. However, heart and liver problems caused by the drug forced the FDA to reject the drug for treatment of menopause symptoms (vii).
Do You Need a Pristiq Lawyer for your Birth Defect Claim?
If you or a loved one has suffered Pristiq birth defects or other Pristiq side effects, then you may have a potential Pristiq lawsuit. You should contact a knowledgeable personal injury lawyer who can evaluate your potential claim file a lawsuit on your behalf, if necessary. d’Oliveira & Associates is currently working with some of the more experienced attorneys in the country who are handling these cases.
Call d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for your free legal consultation.
- (i) Pfizer 2012 Annual Report.
- (ii) FDA Prescribing Information.
- (iii) New England Journal of Medicine, February 2006.
- (iv) New England Journal of Medicine, June 2007.
- (v) CBS News, July 2009.
- (vi) FDA Drug Safety Information, May 2007.
- (vii) Reuters, November 2012.