The EMA has published an information file on combined hormonal contraceptives (CHC). This file refers to the ongoing reassessment of 3rd and 4th generation CHC’s for which the recommendations of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency is expected in October 2013. This file also traces the history of the hormonal contraceptives and subsequent revaluations.
The European Medicines Agency (EMA: European Medicines Agency) has initiated a procedure of reassessment of zolpidem-containing medicines, used for the symptomatic treatment of insomnia (sleeping difficulty). This review has been made in response to concerns related to the onset in some patients of drowsiness and slow reactions the day after taking the medicine, and a potential increased risk of accidents during activities requiring alertness (e.g. when diving).
In June 2013 the PRAC adopted recommendations on HES solutions under Article 31 of Directive 2001/83/EC. A number of marketing authorization holders called for a review of these recommendations. Following the suspension of the use of these medicines in the United Kingdom since 27th June, the EMA has launched a new "urgent" reassessment procedure in accordance with Article 107i of Directive 2001/83/EC. Pending the outcome of these procedures, the recommendations of the PRAC still apply (see press release of 18th June 2013).
Tetrazepam-containing medicines: suspension of the marketing authorization and withdrawal from the market
The famhp sent to the firms concerned the decision of the European Commission of 29th May 2013 to suspend the marketing authorizations (MA) of the tetrazepam-containing medicines throughout the European Union. A recall of all batches of the involved medicines marketed in Belgium (EPSIPAM, MYOLASTAN and TETRAZEPAM EG) must be made by 1st September 2013.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has reviewed all available data on derivatives of ergot-containing medicines. This Committee believes that their benefit / risk balance is most favorable in the treatment of circulatory disorders, cognitive and neuro-sensory disorders as well as in the prevention of migraine. It recommends that physicians reassess the treatment of patients to whom these drugs are prescribed.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends a series of measures to minimize the risks of codeine-containing medicines when they are used for pain control in children.
Solutions for infusion containing hydroxyethyl starch: PRAC recommends suspending their marketing authorization (MA)
The Pharmacovigilance Risk Assessment Comittee (PRAC) of the European Medicines Agency (EMA: European Medicines Agency) concluded, after a review of the available data, that the benefits of infusion solutions containing hydroxyethyl starch (HES) no longer outweigh the risks. It therefore recommends suspending market authorizations for these medicines.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA: European Medicines Agency) estimates that the benefits of diclofenac, an anti-inflammatory medicine (NSAIDs), outweigh the risk of thromboembolic events. PRAC recommends the same measures as those in place to minimize the cardiovascular risk of selective COX-2 (another group of anti-inflammatory).
Medicines containing cyproterone and ethinylestradiol (Diane 35 and generics): the CMDh endorses the recommendations of PRAC
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) confirms the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) by a majority vote (26/1). The benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 mcg) and its generic outweigh the risks, provided that several measures are taken to minimize the risk of thromboembolism (blood clots in the blood vessels).
The European Medicines Agency has reassessed the benefit / risk balance of retigabine, the antiepileptic medicine approved under the name TROBALT. It remains positive for patients who cannot be adequately treated by other medicines. The limited use of this medicine is recommended due to the risk of retinal pigmentation.