Pain and inflammation drug recalled due to omitted dosing and safety information

Omega Pharma Ltd is recalling specific batches of its pain and inflammation medication, napralief 250mg gastro-resistant tablets, because important safety and dosage information is missing from section 2 and section 3 of the patient information leaflet (PIL) and from the outer carton.

Three batches are affected by this class 3 recall. These can be identified by checking the packaging for batch numbers B51496, B51497, and B51102. More information on the affected batches can be found below.

Dr Alison Cave, Medicines and Healthcare products Regulatory Agency chief safety officer, said: ‘Napralief 250mg is considered safe when used in line with the correct dosage instructions. Although small unintentional dosing mistakes are usually not harmful, complete and accurate safety information is essential to help ensure patients use their medicine correctly.’

The affected cartons do not include the instruction that patients must not take more than three tablets a day, which is a key dosage safety message intended to prevent overuse.

In addition, the PIL is missing dosage instructions which state that on the first day patients should take two tablets, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet (250mg) should be taken every 6–8 hours.

The PIL is also missing advice that patients should have an eye examination if they develop visual disturbances, warnings that serious allergic reactions can occur even in people with no previous allergy to painkillers, and guidance to inform a doctor if blood or urine tests are needed, as treatment may need to be stopped 48 hours before testing.

In addition, some information relating to heart problems and associated risk factors, certain autoimmune or mixed connective tissue diseases, and potential serious skin reactions is also missing. As a result of these omissions, patients may not receive the full information required to use the medicine safely.

Dr Cave added: ‘Patients can continue to use the medicine safely in line with the correct safety and dosage instructions. Patients should take two tablets on the first day, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet should be taken every 6–8 hours. Napralief should not be taken for more than three days.’

Napralief 250mg contains the active ingredient naproxen and is a non-steroidal anti-inflammatory drug (NSAID) used to treat muscle or joint pain, such as sprains and strains, inflammation caused by sporting injuries, lower back pain, neck pain or pain in the wrists or feet. It is also used to treat period pain.

Healthcare professionals are advised to stop supplying the affected batches immediately, quarantine all stock and return it to your supplier using your supplier’s approved process.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.