The FDA issues two more enforcement letters this week
The FDA's Office of Prescription Drug Promotion issued two warning letters this week to Spriaso and United-Guardian that state neither drugmaker disclosed risk information in promotional materials.
Spriaso makes Tuxarin ER, a codeine-based cough reliever. United-Guardian markets a catheter irrigation drug, Renacidin. The OPDP issues warning letters for marketing violations that could lead to an enforcement action.
Earlier this week the regulator had issued two untitled letters, which are for less significant violations, to Celgene and Sanofi over distracting direct-to-consumer ads. This marks the OPDP's ninth enforcement letter this year — it issued six untitled letters and three warning letters — matching last year's total.
Regulators charged Spriaso for failing to include risk information on its website for Tuxarin ER and stated that the website makes uninformed claims, like the “current market is dominated by liquids prone to serious risk of dosing errors” and “unlike promethazine no known serious safety issues with Chlorpheniramine.” Regulatory officers also noted that it found the product webpage “particularly alarming” because it's an opioid-based product.
The letter to United-Guardian said a promotional email for Renacidin didn't include risk information except for a link to the drug's prescribing information. Regulators said it also made two claims — that it simplifies catheter care and has easy dosing — for which there was no supporting evidence.
A United-Guardian spokesperson said the company has responded to the FDA's letter and plans to work with them to address all of their concerns. Spriaso did not immediately respond to requests for comment.