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Families Ask GSK to Hand Over Zofran Data

. By Lucy Campbell

Plaintiffs Allege GSK Hid Data from the FDA

Families of patients who allegedly suffered birth defects while taking GlaxoSmithKline’s (GSK) anti-nausea drug Zofran, and who are suing the drug maker in multi-district litigating (MDL) are asking that the drug maker hand over data stored in a drug safety database called “Argus.”

The families have filed a motion to compel, asking US District Judge F. Dennis Saylor IV, who is hearing the MDL, to force GSK to hand over data that the company failed to provide to the US Food and Drug Administration (FDA).

According to the motion, “It constitutes newly acquired safety information known to defendant that GSK should have reported to the FDA and should have prompted GSK to strengthen its representations to doctors and patients about the safety risks of Zofran use in pregnancy.” Further, “How can GSK reasonably suggest that it has not withheld adverse events from the FDA when it refuses discovery from the database where all of the adverse events reside?” the motion asks.

GSK has pushed back against the claims in the MDL, which alleges it fraudulently marketed and promoted Zofran to treat pregnancy-related nausea and vomiting when the FDA cleared it only for nausea and vomiting related to chemotherapy, radiation therapy or operations.

According to the plaintiffs, accessing Argus will enable both sides to easily sort through any reported instance in which using Zofran caused an adverse effect to the patient and find the ones related to pregnancies. “The database is the primary source, and the most comprehensive and usable source of adverse event data in GSK’s possession,” the motion reads. “It contains information from every known Zofran-related adverse event, worldwide, occurring at any time since clinical trials began, including adverse events GSK chose not to report to regulatory authorities.”

So far, the motion states, GSK has cited HIPAA privacy claims, technology burden claims, and the fact that the relevant data is included in the documents already produced in refusing to turn over the Argus data.

There are 400 families who have ongoing lawsuits pending in the Zofran MDL and who are requesting access to the Argus data. They allege that labels for both Zofran and its generic equivalent, ondansetron, fail to specify that the drug has been linked to cardiovascular and cleft palate birth defects.

Zofran (known generically as ondansetron or ondansetron hydrocholoride) is approved by the FDA to prevent nausea and vomiting linked to cancer chemotherapy, radiation therapy and surgery. It is often prescribed off-label to treat morning sickness in pregnant women. Zofran is in a class of medications called 5-HT3 receptor antagonists and is given either orally or through an injection.

The case is In re: Zofran (Ondansetron) Products Liability Litigation, case number 1:15-md-02657, in the U.S. District Court for the District of Massachusetts.

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