NPC Archive Item: MHRA warns about NSAIDs in Drug Safety Update

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The third edition of Drug Safety Update from the Medicines and Healthcare products Regulatory Agency (MHRA) has highlighted updated safety information for several non-steroidal inflammatory drugs (NSAIDs).

Firstly, the MHRA state that piroxicam should only be initiated by specialists as a second-line treatment for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is no longer indicated for any acute indications.

This advice follows evidence that piroxicam is associated with a significantly greater risk of serious gastrointestinal (GI) toxicity (e.g. GI haemorrhage, ulceration and perforation) compared with other NSAIDs. Similarly, it seems to be associated with a higher risk of serious skin reactions (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis).

The MHRA advises that patients who currently take piroxicam should be reviewed at a routine appointment and either switched to an alternative NSAID or referred to a specialist if piroxicam is still considered necessary after consideration of the risks and benefits.

Secondly, prescribers are reminded that ketorolac and ketoprofen have also been associated with a higher GI risk than most other NSAIDs. The MHRA advises that:

  • the maximum duration of treatment should not exceed 7 days for ketorolac tablets, or two days for continuous daily dosing with intravenous or intramuscular formulations.
  • the recommended maximum daily dosage range of ketoprofen is 100–200mg.

General advice on GI safety for all NSAIDs is provided within the newsletter, including the importance of being alert for NSAID drug interactions that may increase the risk of GI ulceration or bleeding (e.g. corticosteroids, aspirin and selective serotonin reuptake inhibitors).

As we highlighted in a previous article, changes to the prescribing information for lumiracoxib are also recommended following a European review of reports of liver toxicity. Liver function must be monitored before and during treatment with this drug.

Bottom line:
Clinicians should be aware of these safety issues regarding NSAIDs. Patients on piroxicam and lumiracoxib should be reviewed at the next routine appointment.