The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2017 (PDF).
This issue contains recommendations following reports of osteonecrosis of the external auditory canal with denosumab (Prolia®). There have been 5 such reports worldwide and clinicians are advised to consider this possibility of osteonecrosis in patients receiving denosumab who present with ear symptoms including chronic ear infections or in those with suspected cholesteatoma. Risk factors include steroid use and chemotherapy, with or without local risk factors such as infection or trauma. Patients on treatment should be advised to report any ear pain, discharge from the ear or an ear infection during denosumab treatment. Any further cases should be reported via the Yellow Card Reporting Scheme.
This issue also notes that there have been reports of systemic cardiovascular effects including bradycardia, hypotension and dizziness after application of brimonidine gel (Mirvaso®). Some cases were reported after laser procedures to the skin. Patients should be advised to avoid application to irritated or damaged skin, including after laser therapy.
Additionally, this issue contains a review on the restriction on sales of pseudoephedrine and ephedrine which has indicated that these measures continue to be successful in managing the risk of misuse. It also encourages use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids). Suspected side-effects, harm to children or non-users and safety issues or defects can all be reported.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.