The U.S. Food and Drug Administration agent responsible for successfully preventing a drug responsible for horrible birth defects out of the United States has passed away at 101. Kelsey Frances was a Canadian-born medical officer for the FDA who refused to approve thalidomide for sale in the U.S., a decision that ultimately saved thousands of lives from horrific birth defects.
Thalidomide, which was being given to treat morning sickness, was found to cause severe birth defects that left children crippled and deformed in the 1950s. The German drug maker responsible for thalidomide only recently formally apologized for the horrific drug, which company representatives were pressuring the FDA to approve.
However, several drugs used to treat nausea are still on the market today and carry fears of similar birth defects. Zofran, which is only approved to treat nausea in post-surgery and cancer patients, has been increasingly given to expectant mothers.
At least 4 studies have recently linked Zofran to birth defects in children born to women who use the drug to treat nausea. Researchers found that the anti-nausea drug could double the risk of several severe birth defects, including cleft palate and cleft lip defects, heart defects, musculoskeletal anomalies and premature birth. Several mothers have filed Zofran lawsuits against manufacturer GlaxoSmithKline alleging that the drug caused birth defects.