EMA advisors have called for a restriction on the use of Servier's osteoporosis drug Protelos/Osseor (strontium ranelate) after linking it to serious potential side effects.
The move comes after their analysis of clinical trial data showed an increased risk of heart problems, including heart attack.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) said the key data came from studies involving around 7,500 patients and showed an increased risk of a heart attack in postmenopausal women taking Protelos/Osseor compared with those taking placebo.
Although there was no increase in deaths, the PRAC said, “the data were of concern given other serious risks” identified in a previous EMA review last year.
That review brought restrictions that included a prohibition on the use of Protelos' in immobilised patients or patients with a history of venous thromboembolism (VTE).
This time around the PRAC wants the EMA's Committee for Medicinal Products for Human Use (CHMP) to consider enforcing the following changes to Protelos' prescribing information:
• Restricting its use for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture and severe osteoporosis in men at increased risk of fracture
• Preventing it from being used in patients with a current or past history of ischaemic heart disease (such as angina or a heart attack), peripheral arterial disease (obstruction of large blood vessels, often in the legs) or cerebrovascular disease (diseases affecting the blood vessels supplying the brain, such as stroke)
• Preventing it from being used in patients with hypertension (high blood pressure) that is not adequately controlled by treatment.
The outcome of the PRAC assessment will be sent to the Agency's Committee for Medicinal Products for Human Use (CHMP), which will adopt a final opinion at the next CHMP meeting of 22 to 25 April 2013.
Pending confirmation from the Committee for Medicinal Products for Human Use (CHMP), this will be the first time that a Periodic Safety Update Report (PSUR) assessment leads directly to a recommendation to restrict the use of a medicine.
PSURs are intended to increase the effectiveness of monitoring the safety of medicines and were brought in under the same major changes to European pharmacovigilance policy that saw the PRAC established.
The changes were prompted by the scandal surrounding another Servier drug, Mediator (benfluorex).
The diabetes medicine was allowed to remain on the market despite serious health concerns emerging and it has subsequently been linked to up to 2,000 deaths.
Once the CHMP issues its final opinion on Servier's Protelos, healthcare professionals in the EU will receive a letter with detailed information on the appropriate actions to be taken, but a final decision on whether to take action on the drug will rest with the European Commission.