FDA Drug Alert Warns That Linzess Should Not Be Used In Children Under Age 6 And Neither Safety Nor Efficacy Established For Those Under 18 Years Old
SUMMARY: As announced by the FDA by means of an August 15, 2014 MedWatch Safety Information email alert, in July 2014 there were several major label changes made to the Linzess Prescribing Information.
The bottom line is that starting last month Linzess should not be prescribed to children less than 6 years old because it may harm them.
There is no indication that Forest Pharmaceuticals has sent a so-called “Dear Doctor” letter to health care providers about these several important major label changes to the effect that Linzess is not a safe IBS and chronic constipation drug for young children.[Read this article in full at original source]
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