UK health authorities are continuing to recall batches of a popular painkiller after discovering a lack of safety information that could affect how it is used safely by patients.
The drug is sold under the name "Nabraleve" in stores such as "Boots" and "Superdrug," and is the trade name for the anti-inflammatory substance "Naproxen," which is used by thousands of patients to treat conditions such as arthritis and gout, as well as menstrual pain and muscle and bone inflammation.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) explained that some batches of the drug do not contain essential information within the patient leaflet, including important warnings relating to safe dosages and the risks of overdose.
Accordingly, the agency issued a decision to withdraw the tablets manufactured by Omega Pharma Ltd., bearing the batch numbers: B51496, B51497 and B51102.
The agency stated that the package insert lacked a clear warning against exceeding three tablets per day, a crucial precaution to avoid the risk of overdose. It also lacked detailed dosing instructions, which typically include taking two tablets on the first day, then one tablet after 6 to 8 hours, and on the second and third days, one tablet (250 mg) every 6 to 8 hours as needed.
The MHRA added that the leaflet should also have included important warnings, including the need to have the eyes examined if any vision disturbances occur, and the possibility of serious allergic reactions even in people who do not have a previous allergy to painkillers.
She also pointed out the importance of informing the doctor when blood or urine tests are needed, as it may be necessary to stop the medication 48 hours before the test, in addition to warnings related to heart disease and its associated risk factors, some autoimmune diseases and connective tissue disorders, as well as the possibility of serious skin reactions.
The agency stressed that these shortcomings could mean that patients are not receiving the complete information necessary to use the drug safely.
Dr. Alison Cave, head of safety at the MHRA, said: "Nabraleve 250 mg is safe when used at the correct dosage." She added, "Minor, unintentional dosing errors do not usually cause harm, but providing accurate and complete information is essential to ensure safe use."
She explained that patients can continue to use the medication according to the guidelines, which are: two tablets on the first day, then one tablet after 6 to 8 hours, and on the second and third days, if needed, one tablet every 6 to 8 hours, provided that the duration of use does not exceed three days.
The agency advised healthcare workers to stop using the affected batches and return them to the suppliers.
