The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 30 August – 02 September 2021. Based on the results of the meeting, a decision was made on the need to make safety-related changes to the registration materials/package leaflet of certain medicinal products.
Pregabalin – PSUSA/00002511/202101
Background
Pregabalin is an analogue of gamma-aminobutyric acid [(S)-3-(aminomethyl)-5-methylhexanoic acid], indicated for the treatment of peripheral and central neuropathic pain in adults, for the treatment of generalized anxiety disorder in adults, and as adjunctive therapy for partial seizures with or without secondary generalization.
Based on the evaluation of the periodic safety update report (PSUR), PRAC reviewed the benefit/risk balance of medicinal products containing pregabalin and provided the following recommendations.
Summary of recommendations and conclusions
- Based on the review of safety and efficacy data, the benefit/risk balance of medicinal products containing pregabalin in the approved indications remains unchanged.
- Nevertheless, the package insert should be updated to add the adverse reaction “parkinsonism” with the frequency “rare”.
Therefore, the instructions for medical use should be updated*.
- Marketing authorization holders (MAHs) must submit to the EMA within 90 days an updated review of cases of abuse and dependence in patients with no history of substance use disorders. The MAH should propose updating the package leaflet if necessary.
- In the next PSUR, the MAH should provide a cumulative review of cases of priapism and paralysis. In addition, the MAH(s) should review new cases related to pregnancy outcomes and congenital malformations.
* Update of the “Adverse reactions” section of the package insert. PRAC recommendations have been forwarded to the CHMP for adoption of an opinion
Scientific conclusions of the Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) and grounds for the need to amend the registration materials
Taking into account the PRAC assessment report on the PSUR for pregabalin, the scientific conclusions of the CHMP are as follows:
Given the available data on the occurrence of drug-induced parkinsonism from spontaneous reports, including literature case reports, and given the existence of a possible mechanism of action, the PRAC considers that a causal relationship between pregabalin and parkinsonism has been established and concluded that the package leaflets of medicinal products containing pregabalin should be amended accordingly.
CHMP agrees with the scientific conclusions of PRAC.
List of medicinal products containing pregabalin that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 03.08.2022). (27 KB) (Downloaded: 15.08.2022 06:06:53)
To analyze the published information, the applicant must use the original text available at the link:
https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-30-august-2-september-2021_en.pdf
https://www.ema.europa.eu/en/documents/scientific-conclusion/lyrica-h-c-psusa-00002511-202101-epar-scientific-conclusions_en.pdf
