The use of a patient reminder card is one of several new measures recommended by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of osteonecrosis (death of bone tissue) of the jaw associated with the bisphosphonate drug zoledronic acid (Aclasta).
The PRAC concluded that the risk of osteonecrosis of the jaw with zoledronic acid — a drug used to treat osteoporosis and other disorders of bone metabolism — was very low, but certain measures are needed to further minimise it.
The patient reminder card would inform patients about the benefits of treating osteoporosis, the risks of osteonecrosis of the jaw, the need to report any dental problems ahead of and during treatment, and the importance of maintaining good dental hygiene.
This information should also be included in the product information along with further details about how to minimise the risk of osteonecrosis of the jaw. The measures, announced on 13 March 2015, follow a routine review of the drug.
The PRAC’s recommendations will be sent to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for the agency’s final opinion. The text of the updated Aclasta product information and the patient card will be published on the EMA’s website after the CHMP opinion expected on 26 March 2015.
The PRAC will also consider similar measures for other intravenous bisphosphonate drugs and for denosumab. These will be considered during the planned reviews for these medicines, which are scheduled to take place during 2015 and 2016.