MANHATTAN (CN) - A boy died from taking two ADHD drugs, Ritalin and Concerta, his parents claim in Federal Court. The Kansas couple says the drug makers never warned them that the drug combination could kill their son with methylphenidate toxicity. The active ingredient in both drugs is methylphenidate - a compound that Concerta releases slowly and Ritalin releases immediately upon digestion.
Edward and Susan Hill of Overland Park say their son Nicholas had taken Ritalin since 1998 and Concerta since 2000 to treat his attention deficit hyperactivity disorder, and that Ortho-McNeil-Janssen, Johnson & Johnson, Novartis and their subsidiaries never warned that the combination could be fatal.
Nicholas took the recommended dosage of each drug, the Hills say, and suddenly suffered nausea and vomiting one day in 2007; they found him unresponsive in his bed that evening.
Nicholas' levels of methylphenidate were so high on the night he died that it would have required him to ingest more than 100 pills, according to the complaint.
The Hills say the drug makers concealed the findings of a 2006 FDA Advisory Committee discussion about the failure to process slow metabolizers associated with methylphenidate drugs. They also say the companies did not warn patients to check for potentially fatal side effects.
The complaint does not state how old Nicholas was when he died. Contemporary news reports said he began taking ADHD drugs when he was 4.
The Hills seek punitive damages for product liability, negligence, breach of warranty and wrongful death. They are represented by Mark Sadaka with Potts Sadaka.
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