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a alert imageNovember 28 2017

The medicines regulator has issued four Drug Safety Updates relating to gentamicin, quinine, oral tacrolimus preparations, and anti-epileptic drugs.

The MHRA’s gentamicin DSU advises about possible high levels of histamine being present in several different batches of gentamicin injections from different marketing authorisation holders. The manufacturing process of the active pharmaceutical ingredient gentamicin may include higher levels of histamine as a residual from the manufacturing process.

Health professionals are advised to monitor patients for signs of histamine-related adverse effects, including anaphylaxis-type reactions, hypotensive reactions, or increased heart rate. Caution should be used in treating patients with gentamicin, especially if they are also using other drugs which may stimulate histamine release.

The DSU on quinine is a reminder of the dose-dependent effect prolonging the QT-interval in heart rhythm. It says the drug “should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.”

Prescribers need to consider conditions that may impact on QT prolongation such as cardiac disease or electrolyte balance, atrioventricular block or concomitant use of other drugs which can affect the QT interval. Patients requiring phenobarbital or carbamazepine need close monitoring as serum levels could become toxic.

The third DSU advises that changes between oral tacrolimus preparations need to be managed carefully, as “inadvertent switching between tacrolimus products has been associated with reports of toxicity and graft rejection …  tacrolimus has a narrow therapeutic index, and even minor differences in blood levels have the potential to cause graft rejection reactions or toxicity.”

A DSU on oral tacrolimus was first issued in 2012, but the advisory has been reissued as new oral tacrolimus products have been licensed or are now being launched into the market.

The final DSU from relates to considerations about switching between different manufacturers’ anti-epileptic drugs. Advice issued in 2013 still stands, relating to the three risk-based categories of anti-epileptics and changing the brand/manufacturer. Health professionals are now being advised that they should additionally take into account the patient’s perceptions about switching brands.

Links:
MHRA DSU on gentamicin            
MHRA DSU on quinine sulphate               
MHRA DSU on tacrolimus              
MHRA DSU on anti-epilepsy drugs

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