Daytrana (Methylphenidate)

Safety Alerts and Recalls

FDA Warns of Rare Risk of Priapism Associated with Methylphenidate Products

What does this mean?

Methylphenidate products are used manage the symptoms of ADHD and the benefits of these medicines will continue to outweigh the risks for most patients. If you or someone you care for takes a methylphenidate product, please be aware that these medicines may rarely cause priapism. If not treated right away, priapism can lead to permanent damage to the penis. Make sure you know the signs and symptoms of priapism – a long-lasting and sometimes painful erection in males of any age. Seek immediate medical treatment should priapism occur. If a younger male is in your care, especially one who has not yet reached puberty, be sure to discuss this possible side effect with him if he is taking a methylphenidate medicine. He may not recognize the problem or may be embarrassed to tell anyone if it occurs. Please read the Medication Guide you receive with your prescription. Talk with your healthcare provider if you have any questions or concerns about methylphenidate products. Do not stop taking your ADHD medicine without first discussing it with your healthcare provider. Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by: --- Telephone: 1-800-332-1088 --- Fax: 1-800-332-0178 --- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 --- Website: www.fda.gov/medwatch
The U.S. Food and Drug Administration (FDA) is warning that methylphenidate products may cause prolonged and sometimes painful erections known as priapism. Methylphenidate products are a type of stimu ...
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