The antidepressant buproprion is sold under the brand name Wellbutrin, but also less commonly as Zyban, Voxra, Budeprion, and Aplenzin (amfebutamone). Researchers are currently trying to determine whether Wellbutrin has caused life-threatening side effects in children born to mothers who were taking the drug while pregnant.
What Is Wellbutrin? When Is It Prescribed?
Wellbutrin is the brand name for the drug buproprion. Made and sold by British pharmaceutical company GlaxoSmithKline Plc., this prescription medication is used to treat severe depression and seasonal affective disorder (SAD). The same chemical compound can also be used as a smoking cessation aid. It has not been approved for weight loss, and recently the U.S. Department of Justice charged a retired GlaxoSmithKline vice president with making false statements and obstructing a federal investigation: The government claims she interfered with federal efforts to uncover illegal marketing of Wellbutrin for weight-loss purposes.
Burroughs Wellcome, a British pharmaceuticals company that has since merged with others into GlaxoSmithKline, first developed buproprion back in 1969. The U.S. Food and Drug Administration (FDA) approved the drug as Wellbutrin in 1985, but it was withdrawn from the market because the dosage was too high, causing seizures in users. Since then, the FDA has reapproved buproprion in various forms: a reduced dosage standard form (Wellbutrin, in 75mg and 100mg doses); a sustained-release form in 1996 (Wellbutrin SR, in 100mg, 150mg, and 200mg doses); and a daily dosage form in 2003 that was further approved for SAD in 2006 (Wellbutrin XL, in 150mg and 300mg doses).
Unlike many antidepressant drugs, especially Selective Serotonin Reuptake Inhibitors (SSRIs), Wellbutrin is a non-tricyclic antidepressant, meaning it prevents the reuptake of two neurotransmitters, dopamine and norepinephrine. Both of these chemicals regulate stress levels in the human brain, but for those suffering from depression stress hormones help ease symptoms. Also unlike SSRIs, it does not cause sexual dysfunction or weight gain. Wellbutrin can cause multiple side effects: drowsiness; excitement; dry mouth; dizziness; headache; nausea; vomiting; tremors; weight loss; constipation; and excessive sweating.
As the adverse effects of Wellbutrin have become better known, the FDA has required more stringent product warnings and prescription requirements, culminating with an October 2004 “black box” Wellbutrin warning. There is no effort to remove the product from the market, and no Wellbutrin recall is in effect. The Rottenstein Law Group does not know of any significant Wellbutrin lawsuits or Wellbutrin class action lawsuits. Meanwhile, however, concerns that antidepressants, including Wellbutrin, are less effective than advertised are growing. For example, the New York Times reported that negative studies on their efficacy are often suppressed.
Wellbutrin Might Cause Birth Defects
If you used Wellbutrin while pregnant and your baby was born with any of the following defects, you might be eligible for compensation for medical bills, lost wages, pain and suffering, and other damages:
- 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 sixteen 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, gastroschisis is 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 Wellbutrin Side Effects
Wellbutrin has been found to cause two other significant side effects: increased thoughts of suicide; and complications for those with pre-existing heart conditions.
Since as early as 1990, there have been reports that antidepressants cause increased suicidal thoughts and behaviors. The FDA considered the issue, but it did nothing more… until 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 GlaxoSmithKline for Wellbutrin, to include added warnings to consumers.
Recently, a study conducted at Duke University concluded that those with coronary artery disease face greater risk of death due to Wellbutrin 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 of the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Wellbutrin lawsuit on your behalf if necessary.
If you have taken Wellbutrin and experienced adverse side effects, contact RLG today.