GlaxoSmithKline Plc has added a black box warning about possible heart risks to its popular ADHD drug Dexedrine. The drug’s packaging will also include information about possible psychiatric adverse events, like hallucinations and mania, linked to stimulants, according to the letter posted on the FDA website. A “black box warning†is the strongest warning a medications warning label can have. Dexedrine is known generically as Dextroamphetamine.
Earlier this year, the Food and Drug Administration advisory panel voted in favor of “black box” warnings on ADHD drugs after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention. Other popular ADHD drugs are Ritalin, Concerta and Adderall.
In 2005, doctors wrote more than 31 million prescriptions for stimulant ADHD drugs, according to IMS Health, a pharmaceutical information company. The drugs are some of the best selling drugs in the world.
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