ADR that result in revision of patient information
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| The United States: Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections |
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The US Food and Administration (FDA) is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism. Based on a recent review of methylphenidate products, FDA updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. If not treated right away, priapism can lead to permanent damage to the penis.
Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs. Healthcare professionals should talk to male patients and their caregivers to make sure they know the signs and symptoms of priapism and stress the need for immediate medical treatment should it occur.
The risk of priapism may cause some healthcare professionals to consider switching patients to the non-stimulant drug Strattera (atomoxetine), another drug used to treat ADHD; however, atomoxetine has also been associated with priapism in young children, teenagers, and adults. Priapism appears to be more common in patients taking atomoxetine than in those taking methylphenidate products; however, because of limitations in available information, FDA does not know how often priapism occurs in patients taking either type of product. Healthcare professionals should be cautious when considering changing patients from methylphenidate to atomoxetine. Patients should not stop taking a methylphenidate product without first discussing it with their healthcare professional.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm378876.htm
In Hong Kong, there are 12 registered pharmaceutical products containing methylphenidate and they are prescription only medicines. So far, the Department of Health has not received any adverse reaction report in connection with the drug. In view of FDA’s recommendations, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, December 18, 2013
Issued at HKT 15:30
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