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Michael Monheit
Michael Monheit
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Zofran Lawsuits Highlight Birth Defect Risk Awareness


Young women aren’t being informed that some of the drugs they take might cause birth defects, a forthcoming paper in the journal Pediatrics has found.

Info About Birth Defect Risks Isn’t Making Its Way To Young Women

The study reviewed the medical records of almost 1,700 female patients between the ages of 14 and 25. Between 2008 and 2012, the women received a little more than 4,500 prescriptions for so-called “teratogenic” drugs, which are known or strongly believed to increase the risk for birth defects if taken during pregnancy. But 70% of the patients weren’t informed of that risk, or counseled about using contraception while taking the drugs.

The paper, which will appear in the January 2016 issue of Pediatrics, was authored by researchers at the University of Missouri at Kansas City, Northwestern University and the University of Colorado. Medline Plus, a digital publication from the US National Library of Medicine, first picked up the study’s results.

Which Teratogenic Drugs Are Most Common?

The researchers also identified the most commonly-prescribed drugs that present birth defect risks:

  1. Topamax (generic: topiramate) – a seizure medication also used to treat migraines
  2. Trexall (generic: methotrexate) – used to treat psoriasis, rheumatoid arthritis and certain types of cancer
  3. Valium (generic: diazepam) – an anxiety medication
  4. Accutane & Claravis (generic: isotretinoin) – used to treat severe cases of acne
  5. Vasotec (generic: enalapril) – a treatment for high blood pressure

Several anxiety drugs, including Klonopen and Xanax, were also mentioned as potentially damaging to fetal development. The researchers say its “unacceptable” for doctors to dole out these dangerous drugs without covering sexual history, and the possibility of becoming pregnant, with patients.

Researchers suggested a disparity between the way this issue is handled with older patients and how it’s handled with younger women.

Zofran Lawsuits Say Anti-Nausea Drug Causes Birth Defects

Teratogenic drugs have seen an increase in public awareness recently, thanks to hundreds of lawsuits filed in relation to Zofran, an anti-nausea drug commonly prescribed to women during early pregnancy.

Zofran was never approved as a morning sickness treatment, and its effects on unborn babies hadn’t been studied until recently. But in 2012, just as Zofran prescriptions during pregnancy reached their peak, a team at Harvard University discovered a troubling association between the drug and cleft palate. Two European studies quickly followed, both of which found that Zofran increased the risk for congenital heart defects by 200% to 400%.

Those results have sparked a wave of litigation, with families across the country accused Zofran’s manufacturer of concealing evidence from the US Food & Drug Administration. Now consolidated in the US District Court for Massachusetts, the Zofran lawsuits will soon be joined by many others, attorneys believe, as parents continue to become aware of the drug’s potential risks.


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