from Great Game India:
Texas Attorney General Ken Paxton has filed a lawsuit against Pfizer for knowingly distributing adulterated drugs to children.
Legal action disclosed on Nov. 20 states that Pfizer and one of its partners distributed a drug to youngsters knowing it was contaminated.
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Texas Attorney General Ken Paxton’s lawsuit claims that Pfizer and Tris Pharma supplied Quillivant XR, a medication for children with attention deficit/hyperactivity disorder (ADHD), while knowing the medication did not fulfill federal criteria.
Quillivant was approved by the US Food and Drug Administration (FDA) in 2012; however, the lawsuit claims that the medication failed quality control testing shortly after the FDA gave its clearance.
Mr. Paxton’s investigation revealed that Tris frequently altered testing procedures, purportedly in an attempt to get good findings, rather than looking into the underlying cause as mandated by federal regulations. The lawsuit claims that Tris increased production “without adequate controls” despite being “under financial pressure” to do so “rapidly.”
Pharmacists dilute Quillivant, which is sold in powder form, with water.
As a Schedule II regulated hazardous substance, the drug must be displayed with a black box warning about abuse and dependency as well as potential adverse effects such nausea, vomiting, and insomnia, as mandated by the FDA. Nextwave Pharmaceuticals created it, and in May 2012, Pfizer purchased it.
Tris was reported to have kept its analysts longer to shake the combination and only tested after no foaming was noticed following a 2012 study that attributed the issues to sample reconstitution.
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