Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 February 2017
PRAC starts a safety referral and concludes one
At its meeting this week, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety review and started a new one. PRAC also started the review of Uptravi (selexipag) in the context of a safety signal and discussed two ongoing referrals.
PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation and that this risk may also apply to other medicines in the same class
The PRAC warns that an increase in cases of lower limb amputation, mostly affecting the toes, has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo, in two ongoing clinical trials involving patients at high risk of heart problems.
An increased risk has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, for these medicines, data available to date are limited and the risk may also apply to these other medicines.
On the basis of the available data, the PRAC recommends that a warning on the risk of lower limb amputation, mostly affecting the toes, should be included in the prescribing information for canagliflozin, empagliflozin and dapagliflozin, highlighting to healthcare professionals and patients the importance of routine preventative foot care.
More information is provided below.
PRAC to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics
The PRAC is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections.
The review has been started at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database and the published literature.
More information is provided below.
PRAC reviewing safety of pulmonary hypertension medicine Uptravi
The PRAC is reviewing the safety of Uptravi (selexipag), following the deaths of 5 patients taking the medicine in France. Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, but use must be in line with the current prescribing information.
The review of Uptravi is being carried out in the context of a safety signal. A safety signal is information on a new or incompletely documented adverse event that is potentially caused by a medicine and that warrants further investigation.
More information is provided below.
Agenda
Agenda - PRAC draft agenda of meeting 6-9 February 2017
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Start of referrals
| Quinolones and fluoroquinolones containing medicinal products |
|---|
Article-31 referral: Quinolones and fluoroquinolones containing medicinal products
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Recommendations by PRAC
| SGLT2 inhibitors (previously Canagliflozin) |
|---|
Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin)
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Safety signal evaluation
| Uptravi (selexipag) |
|---|
| Ongoing signal evaluation |
Ongoing referrals
| Procedure | Status | Update |
|---|---|---|
| Article-31 referral: Factor VIII | Under evaluation | PRAC discussed a list of experts for the ad hoc expert group meeting |
| Article-31 referral: Paracetamol-modified release | Under evaluation | PRAC discussed a list of experts for the ad hoc expert group meeting |
| Article-31 referral: Retinoid-containing medicinal products | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Gadolinium-containing contrast agents | Under evaluation | PRAC continued its assessment |