5. April 2012 11:58
The Chair of the European Medicines Agency’s committee for approving new drugs has resigned suddenly with immediate effect.
Dr Eric Abadie, who has led the Committee for Medicinal Products for Human Use (CHMP) since 2007, stood down after his position at the French healthcare regulator AFSSAPS was questioned.
The regulator has come under scrutiny for allowing the continued sale of Mediator after it had been withdrawn for safety reasons elsewhere.
Concerns have also been raised about the Agency following the controversy over breast implants manufactured by French firm PIP.
Dr Abadie noted in his public declaration of interests with the EMA that he had no links to any pharmaceutical company or health organisation. However, a spokesman said his decision was related to his position at the AFSSAPS, where he works as a scientific advisor to its Director General.
A spokesperson for the EMA said an election for a new chair for the CHMP would happen in “due course”.
In the meantime, Dr Tomas Salmonson, currently the vice-chair of the CHMP, will lead the Committee to ensure a continuity of operations. The next meeting is scheduled for April 16-19.
24. October 2011 10:36
A review has begun into the benefit-risk profile and the conditions of use of Servier’s Protelos (pictured) and Osseor following cases of venous thromboembolism (VTE) and drug rash with eosinophilia and systemic symptoms (DRESS).
The EMA is now analysing strontium-ranelate-containing osteoporosis medicines after links to cardiovascular and cutaneous events were found.
The CHMP says it is now reviewing all relevant data into the links before making a decision whether to change the benefit-risk balance of the medications.
Protelos and Osseor were authorised via the centralised procedure in September 2004 and are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.
The EMA says that VTE and DRESS are known risks of these medicines and are addressed in the risk management plan and have been closely reviewed by the CHMP since their authorisation.
A study analysing the side effects associated with strontium-ranelate-containing medicines noted that there were 199 severe adverse reactions between January 2006 and March 2009. More than half of these (52%) were cardiovascular and more than a quarter (26%) were cutaneous.
The authors of the study concluded that DRESS is unpredictable but the VTE risk could be reduced by adding a contraindication for patients with a risk of cardiovascular risks and by stopping treatment if a new risk occurs.
Based on recent pharmacovigilance update and pending an European review, the French competent authority Afssaps have advised restricting the use of medication including strontium ranelate to patients who are under 80 years of age, at high risk of fractures and who cannot take bisphosphonates.