Tag Archives: Warning

Baxter Receives Third FDA Warning for Misleading Promotional Material

FDA issued a warning letter to Baxter International for making “misleading efficacy claims” about its lung drug Araplast NP, which is contraindicated in individuals with selective IgA deficiencies and prescribed to patients who are at increased risk of emphysema. FDA’s letter, dated Aug. 3, takes issue with claims in a brochure aimed at physicians that […]
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Antiepileptic Drugs To List Suicidality Warnings

Makers of antiepileptic are now required to include a warning that the drugs could boost thoughts of suicide, according to an FDA statement released yesterday. Drugmakers also must create a risk mitigation strategy for each drug and handout a pamphlet to patients spelling out the potential adverse reactions. “Patients being treated with antiepileptic drugs for […]
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