Pharmaceutical

Generic drug makers failed to warn about side effects from heartburn drug Reglan

Reglan 435x303 Generic drug makers failed to warn about side effects from heartburn drug ReglanA Missouri appeals court upheld claims by two women that makers of generic versions of the heartburn drug Reglan failed to update their safety labels to warn about side effects associated with long-term use of the medication.

Reglan, which is sold generically under the name metoclopramide, has been linked to a movement disorder known as tardive dyskinesia. In 2004, manufacturers of brand-name Reglan updated its safety label with the approval of the Food and Drug Administration (FDA) to warn that “Therapy should not exceed 12 weeks in duration.” Generic manufacturers were required to update their safety labels as well but several did not.

The action comes just two weeks after the Alabama Supreme Court ruled that brand name drug manufacturers could be held liable for warnings on generic drugs even if the generic versions were produced by another company. The ruling was based on a federal lawsuit against five current and former drug makers.

Last year, the state Supreme Court ruled that plaintiffs in the case could sue the brand-name drug maker, but the decision was met with a motion from drug companies asking the court to reconsider and a federal judge’s request that the Alabama Supreme Court clarify state law on the issue.

The Missouri case was filed by two women who sued Wyeth, makers of generic Reglan, and other parties, alleging they developed tardive dyskinesia after long-term use of the drug. They claimed that the companies failed to warn them of the risks from side effects associated with the drug.

Sources:
Law360
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