The antidepressant venlafaxine—sold under the brand name Effexor but also less commonly as Efexor, Alventa, Argofan, and Trevilor—has been identified as a potential cause of life-threatening birth defects, such as cleft lip, clubbed foot, and serious heart defects, and other side effects.
What Is Effexor? When Is It Prescribed?
Effexor is a brand name for the drug venlafaxine. Made and sold by American pharmaceutical company Wyeth, now a Pfizer subsidiary, this prescription medication is used to treat major depression, obsessive-compulsive disorder, panic disorder, premenstrual dysphroic disorder, and anxiety disorders. Wyeth received approval from the U.S. Food and Drug Administration (FDA) to market venlafaxine as Effexor in 1993, and the patent expired in 2006. In 2007, it was the sixth most commonly prescribed antidepressant in the U.S., totaling 17.2 million prescriptions in 2007. Venlafaxine comes in oral tablets with dosages ranging from 12.5mg to 150mg.
Effexor is a member of the Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) class of antidepressants. Like Selective Serotonin Reuptake Inhibitors (SSRIs), SNRIs prevent receptors in the human brain from absorbing serotonin that has already been released. Serotonin helps maintain feelings of well-being in people, so preventing its re-absorption alleviates negative feelings. Unlike SSRIs, SNRIs also prevent re-absorption of norepinephrine (also called noradrenaline), which regulates stress levels. SNRIs take a few weeks to affect users, and they can cause many side-effects in the process, particularly nausea, somnolence, and sexual side-effects. It does not cause significant weight gain like SSRIs, though.
As the adverse effects of Effexor have become better known, the FDA has required more stringent product warnings and prescription requirements, culminating with an October 2004 “black box” Effexor warning.
Meanwhile, concerns that antidepressants, including Effexor, are less effective than advertised are growing. For example, the New York Times reported that negative studies on their efficacy are often suppressed. The FDA also sent Wyeth a warning letter in 2007 over an Effexor advertisement in a medical journal that over-hyped its beneficial effects while downplaying the drug’s side effects.
Effexor Might Cause Birth Defects
Effexor reportedly has the potential to cause numerous birth defects, injuries, and other complications, usually when used during the first trimester, including the following:
- Premature birth
- Miscarriage. An article in the Canadian Medical Association Journal reported a study on antidepressants showing that 5.5% of the pregnant women on them suffered spontaneous abortions as opposed to a non-antidepressant-using control group’s 2.7%.
- Withdrawal symptoms, such as: breathing difficulties, turning blue, low blood sugar, jaundice, changing body temperatures, feeding problems, convulsions, vomiting, floppiness, stiffness, irritability, jitteriness, abnormal crying, and tremors.
- Clubbed foot. Called “Congenital Talipes Equinovarus” by medical professionals, one or both feet of children born with this condition are turned inward at the ankle. Most cases are easily treated non-surgically.
- Cleft lip or palate. A cleft lip occurs when the tissue forming a child’s upper lip fails to fuse properly. A cleft palate means the bones comprising the roof of a child’s mouth did not properly join, connecting the mouth to the nasal cavity. Both can be resolved surgically, though a cleft palate can sometimes be fixed by placing a prosthetic device in the palate.
- Delayed development. A February 2010 study published in Pediatrics determined that on average, children born to women who used antidepressants began sitting upright 16 days later than average, and began walking one month later as well.
- Persistent Pulmonary Hypertension (PPHN). An article in the February 2006 issue of the New England Journal of Medicine demonstrated that babies born to women using antidepressants past their 20th week of pregnancy were six times more likely to develop PPHN than women who were not using an antidepressant. PPHN is a life-threatening condition in which high pressure in blood vessels in children’s lungs results in insufficiently oxygenated blood.
- Gastroschisis. Usually a genetic hernia, gastroschisisis a defect on one side of the umbilical cord that allows a portion of the infant’s intestines to protrude out of the body. It is often undetectable before birth, but surgeons can repair the damage by either pushing the intestines back into the body or by stitching a mesh around the protrusion.
- Enlarged heart is condition in which the heart is both too large and weak to efficiently pump blood through the body.
- Septal heart defects. The most common heart defect associated with antidepressants, the wall (septum) separating the left side of the heart from its right is malformed. Sometimes surgery is necessary to correct the damage. The September 2009 edition of the British Medical Journal contained an article showing that women on antidepressants during their first trimesters were twice as likely to give birth to children with septal defects as normal. Taking more than one antidepressant during the first trimester quadrupled the probability of a septal heart defect versus women who did not take the drugs.
- Left outflow tract heart defects. This defect refers to a child born with a narrow aorta, the body’s primary artery, and it requires surgical correction.
- Macrocephaly is a condition in which the child’s head is abnormally large, measured at two standard deviations above the average in head circumference. Macrocephaly correlates to infections, internal bleeding in the skull, cysts on the brain, and other defects.
- Craniosynostosis is a condition in which portions of the child’s skull fuse prematurely, which causes the skull plates to grow in different directions to accommodate the expanding brain. If the skull fails to grow sufficiently, the intracranial pressure on the child’s brain can lead to visual and cognitive impairments.
- Neural tube defects. A neural tube defect consists of an opening in a child’s spinal cord or brain caused by a failure of specialized nerve cells to fuse properly. The several types of defects are horrific and in some instances the child is born without significant portions of the skull and brain. In many circumstances the child does not survive more than a few hours after birth.
- Spina bifida. A more common, specific kind of neural tube defect. Spina bifida is not as fatal as the ones mentioned above because it affects the lower spinal column. In some instances, the spinal cord protrudes through the gap between the unfused bones, and in others a fluid-filled sac surrounds the spinal cord. Sometimes surgeons can close the opening in patients’ backs.
Other Effexor Side Effects
Medical experts have also identified Effexor as a potential cause of two other significant side effects: increased thoughts of suicide; and complications for those with pre-existing heart conditions.
As early as 1990, people reported that antidepressants caused increased suicidal thoughts and behaviors. The FDA considered the issue, but it did nothing more. It became clear that antidepressants could adversely affect children and teenagers, making them hostile, irrational, violent, or suicidal. In 2006, the FDA analyzed the results of 372 studies of antidepressants, finding that even young adults (ages 18-25) were also afflicted with behavioral changes. As a result, the FDA ordered antidepressant manufacturers, including Wyeth for Effexor, to include added warnings to consumers. However, a study, which included venlafaxine users, published in the Feb. 6, 2012 edition of the medical journal, Archives of General Psychology, contradicted earlier findings that connected SSRI use to increased suicidal activity in youths. Although, the researchers did not detect a decrease in suicidal thoughts and behaviors compared to adults and geriatric patients.
Recently, a study conducted at Duke University concluded that those with coronary artery disease faced greater risk of death due to Effexor use. The researchers could not determine the reasons for the connection, but they found the connection statistically significant. For those with heart disease, in an average three years of follow-up, 21.4 percent of the participants still on antidepressants died as opposed to 12.5 percent who were not on antidepressants.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group do everything they can to streamline the process of helping you to obtain compensation.
If you have taken Effexor and believe it harmed you, contact RLG today.