Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks.
The letter failed to mention any warnings, contraindications, precautions or adequate directions for use for Diclegis (doxylamine succinate and pyridoxine hydrochloride), the FDA says in an untitled letter released Nov. 22. The FDA approved the drug in April to treat nausea and vomiting in certain pregnant women.
In addition to the risk omission, Duchesnay’s sales letter failed to properly convey that the drug wasn’t studied in women with hyperemesis gravidarum, a rare disorder that can lead to extreme nausea and vomiting in pregnant women, the agency said.
The FDA also knocked Duchesnay for not naming the active ingredient alongside the drug’s brand name, a common issue that drugmakers struggle with.
The FDA wants Duchesnay to immediately stop distributing the letter about Diclegis.
The Diclegis sales letter inadvertently omitted the inclusion of a product logo and a footer that included important safety information as well as a link to the full prescribing information, none of which has since nor will be disseminated again in the future, Duchesnay spokesperson Laney Landsman said. “The company is making every effort to comply with all regulatory requirements and has taken affirmative steps to reinforce its commitment to regulatory compliance.”
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