- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Drug Safety Update - October 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2017 (PDF).

This issue warns clinicians that Solu-Medrone 40mg contains lactose derived from cows' milk and as such it may contain trace amounts of milk proteins. As such, this product must not be used in patients with known or suspected allergy to cows' milk. Serious allergic reactions have been reported.

It is also noted that gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients at higher risk of experiencing severe respiratory depression include those with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and elderly people. Dose adjustments might be necessary in these patients. Gabapentin is usually started at low dose and increased based on efficacy and tolerance; directly asking patients about respiratory symptoms during dose increases may be prudent.

Isotretinoin has been associated with rare reports of erectile dysfunction and decreased libido. Further reporting of any suspected adverse events is recommended.

Clinicians are also reminded of the potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus with Clozapine. It is therefore vital that constipation is recognised and actively treated and particular care should be exercised in patients receiving other drugs known to cause constipation, those with history of colonic disease or lower abdominal surgery, and in patients aged 60 years and older.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.