New studies point to an increased risk of Paxil birth defects in babies whose mothers use the antidepressant during pregnancy. According to the findings of two studies, women who were taking Paxil during their first trimester were one and a half to two times more likely to have a baby with a heart defect than women who were taking other antidepressants or women of the general population.
A study published in the February 2006 issue of the New England Journal of Medicine found that maternal use of the antidepressant Paxil increased the risk—by as much as six times—of a birth defect known as persistent pulmonary hypertension, or PPHN.
Babies born with PPHN have difficulty circulating oxygen through their bodies because of constricted blood vessels in the heart and lungs.
The heart malformations reported in the two studies ranged from minor to severe defects, some of which required surgery to repair. In most cases, the defects were atrial and ventricular septal defects, which are holes in the walls of the heart’s chambers.
These defects were most likely to occur in the first trimester. Other complications found in babies whose mothers used Paxil during this time included: breathing problems, seizures, low blood sugar, irritability and tremors.
In July 2006, the FDA warned of the risk of PPHN in babies when taken later—after the 20 th week—of pregnancy. The FDA’s warning was prompted by a study published several months earlier in the New England Journal of Medicine.
Babies with PPHN become very sick because of abnormal blood flow in the heart and lungs. The inhibited blood flow prevents oxygen from getting to vital organs and may result in multiple organ failure and death.
Even prompt treatment does not guarantee a positive outcome. Some babies still have difficulty getting an adequate oxygen supply to their bodies and those who survive may suffer from lifelong disability.
Paxil was the third SSRI (selective serotonin reuptake inhibitor) to hit the U.S. market for the treatment of depression and other psychiatric disorders. Since its release in 1992, the drug has been the subject of numerous labeling changes—most recently, to reflect the risk of Paxil birth defects but also to highlight the risk of suicidal behavior in children and adults.
Due to the risk of Paxil birth defects, the FDA urged the drug’s maker to change the pregnancy category on the drug from C to D, which means that studies in pregnant women have demonstrated risks to the fetus.
If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous drugs, bad products, or toxic injury etc then please contact the Dallas Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.
The Dr. Shezad Malik Law is currently evaluating and accepting Paxil Birth Defect cases.