New FDA Rule Requires Drug Company To Replace Current Simple Pregnancy Category Designation With A Summary Of The Risks Of Using Zofran During Pregnancy
UPDATE: Novartis and GlaxoSmithKline (GSK) have reportedly completed the final stages of GSK’s oncology portfolio buyout. As such, Novartis is now the responsible drug company for Zofran and would be making any Zofran label changes going forward.
Starting earlier this year drug injury products liability lawsuits alleging birth defects caused by the use of Zofran (ondansetron) during pregnancy for so-called "morning sickness" have been filed against the pharmaceutical company GlaxoSmithKline (also known as GSK or Glaxo).
One standard contention found in the Zofran lawsuit Complaints filed to date is as follows:
GSK falsely and negligently represented to the medical community and expectant mothers, including Plaintiff and her providers, that:
a. Zofran was safe and effective for treating pregnancy-related nausea;
b. Zofran had been adequately tested and studied in pregnant women;
c. Zofran use during pregnancy did not increase the risk of bearing children with birth defects; and,
d. Zofran’s “Pregnancy Category B” designation established the safety and efficacy of Zofran for treating pregnancy-related nausea.
In December 2014 the FDA issued a new regulatory rule that seems to require GlaxoSmithKline in the next couple of months to make an important decision which may impact the Zofran lawsuits, those already filed and those that will be filed in the future.
In particular, it seems that Glaxo will need to decide what, if anything, it will disclose, i.e., admits to know, as regards the association between Zofran and birth defects such as congenital heart defects and cleft palate or lip.
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As regards this new FDA rule, which takes effect in June 2015, from this recent article, "FDA aims to dispel 'myth of the medication-free pregnancy'", published by the Chicago Tribune:
The revisions to prescription guidelines — the first since 1979 — will provide more up-to-date and specific information to doctors to help them identify the safest treatment options for common conditions during pregnancy, [said Dr. Katherine Wisner, a professor and psychiatrist at Northwestern University Feinberg School of Medicine, who advised the FDA on the changes], who specializes in maternal mood disorders.
The old system relied on letter grades of A,B,C, D and X — A for the most benign medications to X for off-limits. The new system is designed to give physicians more technical information when prescribing medications, said Sandy Walsh, an FDA spokeswoman.
The updated prescribing guidelines consist of three components. The first gives physicians information on dosing and risks to the fetus....
The letter labels were "confusing and overly simplistic," Wisner said. "But now doctors and patients will have quality data to provide better answers. ... We're moving from a single letter to more practical guidelines."
In essence, for GlaxoSmithKline, the company will be required to remove the current Pregnancy Category B designation designation from its Zofran drug product labeling and instead: (1) summarize the risks of using Zofran during pregnancy; (2) discuss the medical as well as clinical data about Zofran supporting that summary; and, (3) describe relevant information to help health care providers make prescribing decisions and counsel women about the use of Zofran during pregnancy.
Here are links to the current Zofran Prescribing Information documents (accessed 4/28/15) for the various forms of that GSK drug currently approved by the FDA.
It will be interesting to check those Zofran drug label documents in a couple of months from now to see what revisions have been made by Glaxo to conform to this new FDA rule.
And it would not be a surprise if just how those Zofran label changes were made had something to do with the current Zofran - birth defects lawsuits.