16. March 2012 13:58
The European Medicines Agency (EMA) has recommended label changes to Servier’s osteoporosis drugs Protelos and Osseor to include new contraindications and revised warnings.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the drugs are an important treatment for women with osteoporosis, but that the associated risks need better management.
The CHMP no longer recommends Protelos and Osseor (strontium ranelate) for use in immobilised patients or patients with venous thromboembolism (VTE), and has recommended an update of the warnings regarding serious skin reactions.
Both drugs are indicated for the treatment of osteoporosis in postmenopausal women to reduce the risk of hip and spine fractures.
The review followed the publication of a French study that identified 199 severe adverse reactions to these medicines between January 2006 and March 2009. Around half were VTE events and around a quarter were skin reactions.
The risk of VTE was identified in clinical trials, and the risk of severe skin reactions had been reported from patient experience. These risks were already noted in the product information.
The CHMP has reviewed all available data on the safety of Protelos and Osseor and recommended:
• Doctors should not prescribe these drugs for patients with VTE or a history of VTE, or to patients who are immobilised. Patients in these categories should discuss their treatment with their doctor at their next scheduled appointment.
• Doctors should re-evaluate the need to continue treatment with Protelos or Osseor in patients over 80 years of age at risk of VTE.
• Prescribers should make patients aware of the time-to-onset and likely signs and symptoms of severe skin reactions. Patients should stop treatment immediately if such symptoms occur, and not resume at any time.