Magazine article Clinical Psychiatry News

FDA Warns Methylphenidate Drugs Tied to Priapism

Magazine article Clinical Psychiatry News

FDA Warns Methylphenidate Drugs Tied to Priapism

Article excerpt

In very rare cases, methylphenidate medications have been associated with priapism in both boys and men taking the drugs for attention-deficit/hyperactivity disorder, the Food and Drug Administration has reported.

Records of the FDA Adverse Event Reporting System, combined with data from the extant literature, identified 15 cases of priapism associated with the drug's use. The cases occurred from 1997-2012; most (12) occurred in patients younger than 18 years. The patients' mean age was 12, although ages ranged from 8 to 33 years.

In response to the findings, the FDA has updated the methylphenidate drug labels and patient information leaflets to include information about the condition. Patients who take methylphenidate and develop erections lasting longer than 4 hours should seek immediate medical treatment to prevent longterm problems with the penis.

Priapism occurred after withdrawal of methylphenidate in four patients, but also under other conditions, such as restarting the drug, or when there was a longer than typical time between doses, FDA noted in a safety announcement. Two patients required surgical intervention--one with a shunt and the other with needle aspiration of the corpus cavernosum. …

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