Wellbutrin Side Effects Injury Lawsuits – News Article. Wellbutrin & SSRI’s Linked To Birth Defects – News Article. If your child suffers from a birth defect and you took an SSRI antidepressant while pregnant the medication could be to blame. Parker Waichman LLP, a personal injury law firm, is investigating potential lawsuits on behalf of families whose children suffered a birth defect that may be associated with SSRI antidepressants, including persistent pulmonary hypertension of the newborn (PPHN), ventricular outflow defects, hypoplastic left heart syndrome (HLHS), neural tube defects and more shown below. Several studies, such as a Danish study published in 2005 which found that infants exposed to SSRIs during the first trimester of pregnancy had a 60% higher probability of developing heart birth defects. Other studies have indicated that children exposed to SSRIs may be more likely to suffer congenital abnormalities. In 2006, the U.S. Food & Drug Administration (FDA) asked the manufacturers of several SSRI antidepressants to add information to their labels describing the potential risk of PPHN after a study in the New England Journal of Medicine found a six-fold increased risk of the disorder among infants born to mothers who took an antidepressant in the last trimester of pregnancy.
If you have taken Wellbutrin, and have given birth to a child with a birth defect the defective drug may be to blame. Below is a list of potential birth defects that may be linked to the use of Wellbutrin:
- Congenital heart lesions & anomalies
- Down’s syndrome
- Undescended testes in males
- Spina bifida
- Clubfoot (one or both feet turn downward and inward)
- Septal defects; Cleft lip and/or cleft palate
Suicidal Behavior, Suicide Ideation Side Effects for Wellbutrin Users
On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky and proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.
The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.
In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.
Top Food and Drug Administration (FDA) officials have said publicly for the first time that scientific trials of frequently prescribed antidepressants have powerfully demonstrated that children who took the medications faced an increased risk of suicide. Testifying before two FDA advisory committees, the officials said a recent study contracted by the FDA and conducted by Columbia University confirmed the findings of an internal analysis early this year. In clinical trials, the drugs almost doubled the incidence of suicidal behavior in children.
After hearings where parents told of the effects these drugs had on their children, the FDA ordered manufacturers of 10 frequently prescribed antidepressants: Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron to include warnings about an increased risk of deepening depression or even suicide on product labels and urged patients and their families to report any changes in behavior to their doctors.
Concerns about a possible link between the drugs and suicide were raised in the media and by some psychiatrists in 1990. The FDA convened an advisory panel on the topic but issued no warnings.
Antidepressant Risk for Heart Disease Patients
In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs. During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.
Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However, their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.