Pfizer and one of its partners distributed a medication to children despite having knowledge that the drug was adulterated, according to legal action unsealed on Nov. 20.
Pfizer and Tris Pharma distributed Quillivant XR, a drug for children aimed at treating attention-deficit/hyperactivity disorder (ADHD), even though the companies knew the drug did not meet federal standards, the lawsuit from Texas Attorney General Ken Paxton says.
The U.S. Food and Drug Administration (FDA) approved Quillivant in 2012 but soon after its approval, the drug failed quality control tests, according to the suit.
Instead of investigating the root cause, as required by federal rules, Tris repeatedly changed testing methods allegedly to try to generate positive results, Mr. Paxton’s probe found. Tris was “under financial pressure” to “rapidly increase production” and did ramp up production but “without adequate controls,” the suit states.
Quillivant comes in powder form and is reconstituted by pharmacists with water.
The medication is a schedule II controlled dangerous substance, and suppliers are required by the FDA to ensure display of a black box warning about abuse and dependence, and the potential side effects which include nausea, vomiting, and insomnia. It was developed by Nextwave Pharmaceuticals, and was acquired by Pfizer in May 2012.
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