EMA's PRAC investigates new safety signals
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EMA’s PRAC investigates new safety signals – Steve McMillan – The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) met from 3–5 September 2012.1 Among other items, the committee discussed the following new safety signals.
Adalimumab & dermatomyositis A signal of dermatomyositis was identified by the EMA, based on 14 case reports retrieved from EudraVigilance. Based on the available data, PRAC agreed that the signal warranted further review, as it could not be excluded that exposure to adalimumab [Humira] had caused a worsening and/or progression of dermatomyositis symptoms. Because use of infliximab had also been mentioned in one particular case, PRAC agreed that the data for this substance should also be reviewed.
information may require updating, depending on the strength of the signal. Several cases of rhabdomyolysis occurred when roxithromycin was added to existing treatment with statins. PRAC discussed the biological rationale for the potential drug-drug interaction and concluded that such an interaction was plausible. Therefore, the committee agreed that this signal also required further investigation.
Sitagliptin & rhabdomyolysis
PRAC decided that the involvement of cinacalcet [Mimpara] in the development of QT prolongation and ventricular arrhythmias could not be excluded from 15 case reports retrieved from EudraVigilance, particularly considering cinacalcet’s effect on calcium levels. Most of the identified patients had underlying cardiovascular disorders, which may be a confounding factor. The risk of QT prolongation/ventricular arrhythmias is already acknowledged in the Risk Management Plan for cinacalcet; however, the new data may prompt a strengthening of risk minimisation strategies.
A signal of rhabdomyolysis was also discovered in association with use of sitagliptin [Januvia, Ristaben, Tesavel, Xelevia]. The EMA identified 41 case reports in EudraVigilance, a number of which involved coadministration with statins. Several cases involved elderly patients, in whom rhabdomyolsis developed when sitagliptin was added to an existing multitherapeutic regimen. Often these elderly patients had renal insufficiency. PRAC agreed that more information should be gathered, particularly regarding the potential drug-drug interaction between sitagliptin and statins. Depending on the outcome of these investigations, PRAC will consider the need for a review of the entire class of DPP-4 inhibitors.
Clopidogrel & eosinophilic pneumonia
Somatropin, varenicline & convulsions
Cinacalcet & QT prolongation/arrhythmias
A review of seven cases contained in EudrVigilance identified a signal of eosinophilic pneumonia in association with clopidogrel [Plavix, + generic products]. While PRAC noted that this adverse event had been rarely reported with clopidogrel, it decided that it was important to evaluate the drug’s possible causal role, given that discontinuing treatment could be critical when such a reaction occurs.
Duloxetine-aripiprazole interaction The product information for medicines containing duloxeti
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