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Ironwood Irritable-Bowel Drug Gets Revised FDA Warning Label

Ironwood's Linzess irritable-bowel drug gets a revised FDA warning label.
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Ironwood Pharmaceuticals  (IRWD) - Get Ironwood Pharmaceuticals, Inc. Class A Report shares on Thursday rose after it said that the FDA approved a revised label for its Linzess treatment for irritable-bowel syndrome.

The revised label warns of the risk of serious dehydration and contraindication against use in children younger than two. 

Prior to the change, the dehydration warning applied to people younger than 18, and the contraindication applied to those younger than six.

Ironwood stock recently traded at $13.24, up 1%. The shares soared 45% in the six months through Wednesday.

“The Food and Drug Administration approved a revised label for Linzess [generically linaclotide] based on clinical safety data that has been generated thus far in pediatric studies,” the company said.

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“The updated label modifies the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age. … The safety and effectiveness of Linzess in patients less than 18 years of age have not been established.”

So what changed? “The warning on the Linzess label at launch was primarily applied due to preclinical findings, and there was an absence of any clinical data in pediatric populations at the time,” said Michael Shetzline, chief medical officer at Ironwood.

"The warning on the Linzess label at launch was primarily applied due to preclinical findings, and there was an absence of any clinical data in pediatric populations at the time,” said Michael Shetzline, chief medical officer at Ironwood.

“We look forward to continuing to investigate the safety and efficacy of Linzess for children.”

To be sure, “Further clinical data are also required to establish the safety and efficacy of Linzess in the population less than 18 years of age),” Ironwood said. “Diarrhea, including severe diarrhea, is a potentially serious side effect of Linzess.”