Prozac, Birth Defects Warnings
Parker Waichman LLP, a personal injury law firm is investigating incidents of birth defects associated with Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants. Studies have indicated that mothers who take such drugs – especially in the first three months of pregnancy – may be at a higher risk of having a child with a birth defect. Some birth defects that may be associated with SSRIs include heart defects such as ventricular outflow abnormalities, septal defects, hypoplastic left heart syndrome (HLHS), and persistent pulmonary hypertension of the newborn (PPHN); neural tube defects such as spina bifida and more listed below. In 2006, the FDA issued a warning regarding a possible association between PPHN and SSRIs in the second half of pregnancy. The year prior, a Danish study showed that infants exposed to SSRIs during the first trimester of pregnancy had a 60% higher probability of developing congenital heart defects when compared with infants whose mothers did not take the drugs.
If you have taken Prozac, 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 Prozac:
- 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
On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency 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.
Prozac Suicidal Behavior Side Effects
Reports of suicidal behavior in children and adolescents taking Eli Lilly & Co.’s Prozac (Generic: Fluoxetine) are becoming widespread. Prozac was introduced in the U.S. in 1988 and was the only antidepressant certified as safe for children. Robert Temple, director of the Office of Drug Evaluation at the FDA, said that a large new study added to previous research on Prozac and showed that kids taking the drug have about a 50 percent higher risk of suicidal thoughts and suicide attempts. Temple spoke at the first day of hearings on potential label changes for antidepressants taken by more than a million children and teenagers.
Following a February 2004 hearing, the FDA in March asked drug companies to relabel 10 antidepressants, warning that young patients should be watched for worsening depression and anxiety. Critics at the time thought the move came too late, considering that, in December, British drug regulators had advised doctors to prescribe only Prozac for depressed kids. Other major antidepressants prescribed for kids already have been found to raise the risk of suicidal behavior. Prozac had been an exception. “What’s interesting and persuasive is that these studies now all lean the same way,” Temple says.
Dozens of parents testified at the hearing that antidepressants had caused their children to kill themselves or others. Their claims were “passionate and plausible,” says psychiatrist Wayne Goodman, chairman of the FDA advisory panel. On average, antidepressants taken by kids will cause an extra 2 percent to 3 percent to have increased suicidal thoughts, the independent experts, working with Columbia University, found.
Relative risks of suicidal behavior were highest among youths taking Luvox, Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac. Two FDA advisory panels are considering whether agency action including stronger warning labels is needed on nine antidepressants linked to heightened suicidal tendencies among children.
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.
Legal Help For Victims Affected By Prozac
If you or a loved one took Prozac or other antidepressant medicatioon and suffered any of aforementioned side effects, please fill out the form at the right for a free case evaluation by a qualified defective drug attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).