The European Medicines Agency has completed a safety review and made on several recommendations to ensure safer use of methylphenidate.
According to the press release safety concerns have been raised in recent years in terms of cardiovascular and cerebrovascular risks. A question and answer document provides more details about the review.
The review concludes that the benefits of methylphenidate continue to outweigh the risks but that prescribing information needs to be made more consistent across the European Union. It is also recommended that the product information for all methylphenidate products contain the following:
- Before treatment, all patients should be screened to see if they have any problems with their blood pressure or heart rate. The family history of cardiovascular problems should also be checked. Any patients with these problems should not be treated without specialist evaluation
- During treatment, blood pressure and heart rate should be monitored regularly. Any problems that develop should be investigated promptly
- There is a lack of information on the long-term effects of methylphenidate. For patients who take methylphenidate for more than a year, doctors should interrupt treatment at least once a year to determine whether continued treatment with methylphenidate is necessary
- The use of methylphenidate could cause or worsen some psychiatric disorders such as depression, suicidal thoughts, hostility, psychosis and mania. All patients should be carefully screened for these disorders before treatment and monitored regularly for psychiatric symptoms during treatment
- The height and weight of patients treated with methylphenidate should be monitored during treatment
Action: Clinicians should be aware of these recommendations and ensure that screening and monitoring checks are completed as suggested.
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