FDA Warns of Rare Side Effect for ADHD Drugs
What happened
The U.S. Food and Drug Administration has issued a new warning for methylphenidate-based ADHD medications, such as Ritalin and Concerta, regarding a rare but significant risk of priapism. The alert, which also covers drugs like Quillivant XR, underscores the importance of close medical monitoring for patients taking these stimulants.
Why it matters
- This specific FDA warning was originally issued in December 2013, updating drug labels and patient medication guides to include the risk of priapism. - The FDA's review at the time found 15 reported cases of priapism linked to methylphenidate between 1997 and 2012, with a median patient age of 12.5 years. - Priapism occurred not only after dosage increases but also during periods of temporary drug cessation, longer-than-usual times between doses, or after stopping the medication completely. - Some of the reported cases were severe, with two patients requiring surgical intervention to treat the condition. - The FDA noted that boys who have not yet reached puberty may not recognize the signs of priapism or may be too embarrassed to tell a parent or guardian. - The non-stimulant ADHD medication atomoxetine (Strattera) also carries a warning for priapism, and the side effect appears to be more common with atomoxetine than with methylphenidate products. - While four cases of priapism were reported with amphetamine-based ADHD drugs, the FDA could not establish a direct causal link as other medications were also involved. - Any erection lasting more than four hours is considered a medical emergency (priapism) and requires immediate medical attention to prevent permanent damage.
Key numbers
- - This specific FDA warning was originally issued in December 2013, updating drug labels and patient medication guides to include the risk of priapism.
- The FDA's review at the time found 15 reported cases of priapism linked to methylphenidate between 1997 and 2012, with a median patient age of 12.5 years.
What happens next
- The FDA noted that boys who have not yet reached puberty may not recognize the signs of priapism or may be too embarrassed to tell a parent or guardian.
- While four cases of priapism were reported with amphetamine-based ADHD drugs, the FDA could not establish a direct causal link as other medications were also involved.
Quick answers
What happened in FDA Warns of Rare Side Effect for ADHD Drugs?
The U.S. Food and Drug Administration has issued a new warning for methylphenidate-based ADHD medications, such as Ritalin and Concerta, regarding a rare but significant risk of priapism. The alert, which also covers drugs like Quillivant XR, underscores the importance of close medical monitoring for patients taking these stimulants.
Why does FDA Warns of Rare Side Effect for ADHD Drugs matter?
This specific FDA warning was originally issued in December 2013, updating drug labels and patient medication guides to include the risk of priapism. The FDA's review at the time found 15 reported cases of priapism linked to methylphenidate between 1997 and 2012, with a median patient age of 12.5 years. Priapism occurred not only after dosage increases but also during periods of temporary drug cessation, longer-than-usual times between doses, or after stopping the medication completely. Some of the reported cases were severe, with two patients requiring surgical intervention to treat the condition. The FDA noted that boys who have not yet reached puberty may not recognize the signs of priapism or may be too embarrassed to tell a parent or guardian. The non-stimulant ADHD medication atomoxetine (Strattera) also carries a warning for priapism, and the side effect appears to be more common with atomoxetine than with methylphenidate products. While four cases of priapism were reported with amphetamine-based ADHD drugs, the FDA could not establish a direct causal link as other medications were also involved. Any erection lasting more than four hours is considered a medical emergency (priapism) and requires immediate medical attention to prevent permanent damage.
