Methylphenidate

13.08.2019 Updated 26.11.2020 5628 views

Regarding amendments to the package leaflets of medicinal products containing methylphenidate

Dear applicants!

The Pharmacovigilance Risk Assessment Committee (PRAC), based on the assessment of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing methylphenidate, reached the following conclusions:

The results of a large cohort study do not indicate an increased risk of overall congenital malformations associated with in utero exposure to methylphenidate. However, a small increase in the risk of cardiac malformations was identified (associated with in utero exposure to methylphenidate in the first trimester). Therefore, marketing authorization holders of medicinal products containing methylphenidate must amend the section “Special warnings and precautions for use” of the instructions for medical use by adding the relevant information.

Based on literature and database data, 28 cases of urinary incontinence/enuresis were identified, of which 12 cases confirmed a causal relationship between the use of medicinal products containing methylphenidate and urinary incontinence.

Also, 67 cases of trismus were identified, of which 12 cases had a causal relationship between trismus and methylphenidate.

According to the results of literature data, cases of bruxism registered after the use of methylphenidate were identified.

In studies conducted with methylphenidate in adults, the incidence of hyperhidrosis varied from 1,3% to 8,8%. Thus, the incidence of hyperhidrosis in adults increased.

Marketing authorization holders of medicinal products containing methylphenidate must amend the "Adverse reactions" section of the package leaflet by adding information on: