MHRA issues class 4 drug alert for Oxylan Prolonged-release tablets

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for Oxylan Prolonged-release tablets (oxycodone hydrochloride).

G.L. Pharma GmbH T/A Healthcare Pharma Ltd has informed the government agency that the Patient Information Leaflet (PIL) within the packs for certain batches are missing important safety-relevant text changes.

The changes to the PIL include the addition of the following information:

• Warnings and precautions: If you have poor adrenal gland function (your adrenal gland is not working properly) for example Addinson’s disease.
• Other medicines and Oxylan: The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.
• Possible side effects, Frequency unknown: Long term use of Oxylan during pregnancy may cause life-threatening withdrawal symptoms in the new-born. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.

Pharmacists are asked to ensure that patients are aware of any missing information and issue the current PIL with special warning and precautions.

Product details:

Oxylan 10 mg prolonged-release tablets PL 21597/0062

Oxylan 20 mg prolonged-release tablets PL 21597/0063

Oxylan 40 mg prolonged-release tablets PL 21597/0063

Oxylan 80 mg prolonged-release tablets PL 21597/0063