This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
It appears we are about to see a long delayed and much-needed warning added to the Zoloft label.
Pfizer Inc. is in talks with the U.S. Food and Drug Administration to update the label on its antidepressant Zoloft to finally and at long last acknowledge studies showing increased heart defect risks in children whose mothers took the drug early in their pregnancies. As expected, the spin doctors at the drugmaker stressed Friday that the proposal was not prompted by new data or litigation. Pfizer claims the proposed label change on Zoloft was prompted by an FDA move to revamp pregnancy labeling on all prescription drugs.
The embattled drugmaker, which is fielding multidistrict litigation in Pennsylvania federal court over cardiac birth defect risks, said the proposed label change was prompted by an FDA move to revamp pregnancy labeling on all prescription drugs. The proposed label will still emphasize that the “weight of evidence” indicates no difference in major birth defects between children of women who took the medication during their first trimester and those born to women who didn’t take it.
The proposed label would state that “an increased risk of congenital cardiac defects, specifically septal defects … was observed in some published epidemiological studies” involving women who took the drug during their first trimesters but would also include caveats about the limitations of those studies, according to court documents.
Pfizer has similarly argued in litigation that there isn’t enough research to suggest that taking Zoloft during a pregnancy can lead to birth defects. It has argued that the background rate of birth defects has not seen a statistically significant change since the advent of selective serotonin reuptake inhibitors, or SSRIs, like Zoloft.
However, the FDA issued a final rule in December requiring that drugmakers more clearly list the potential risks of taking a drug during pregnancy. The agency said the new labeling rules establish “detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.”
Pfizer has so far won the first two trials alleging birth defect risks of Zoloft, both in state court.
Federal bellwether trials in the Pennsylvania MDL are scheduled for 2016.
About the Firm: The Michael Brady Lynch Firm is a national trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Xarelto bleeding injuries, Mirena IUD, Actos Bladder Cancer, Invokana ketoacidosis, Testosterone heart attack and stroke injuries and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.