Screen all patients for TB before starting TNF-alpha inhibitors, says DSU
All patients should be screened for active and latent tuberculosis before starting treatment with a tumour necrosis factor alpha (TNF-alpha) inhibitor, the Medicines and Healthcare products Regulatory Agency advises in its latest Drug Safety Update (April 2014). Patients should be monitored closely for infectious diseases, including tuberculosis (TB), before, during and after treatment, it adds.
The DSU says that large observational studies have confirmed an increased risk of TB in patients treated with TNF-alpha inhibitors and that reports of TB, including fatalities, in patients treated with TNF-alpha inhibitors continue to be received via the yellow card scheme. The TNF-alpha inhibitors authorised in the UK are adalimumab, certolizumab, etanercept, golimumab, and infliximab.
In many cases, extrapulmonary TB, presenting as either local or disseminated disease, has been reported. The DSU adds that in one recent case, a patient receiving a TNF-alpha inhibitor died from TB that had not been diagnosed.
Healthcare professionals should give patients an alert card, which companies are required to produce, that warns them of the risk of infectious diseases, particularly TB. The card describes possible signs and symptoms of TB and advises patients to inform their doctor if they have signs of an infection, the DSU says.
The April DSU highlights a number of other issues, including an update to the online yellow card form to increase and improve reporting of suspected adverse reactions to medicines taken during pregnancy. It also points out that the packaging of some morphine sulfate products has been updated to better highlight the strength of the medicine on the pack and ensure the correct strength is dispensed.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138243
Recommended from Pharmaceutical Press