The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent warning regarding a potentially fatal mix-up involving the antidepressant sertraline. Over two million Britons rely on this medication to manage depression, anxiety, and mood disorders such as obsessive compulsive disorder (OCD).
What Happened?
A manufacturing error led to some packets of sertraline 100mg film-coated tablets containing a different medication entirely. Specifically, one blister strip of citalopram 40mg film-coated tablets was found inside a sealed carton of sertraline. Both drugs are selective serotonin reuptake inhibitors (SSRIs), but taking them together can trigger serotonin syndrome, a life-threatening condition.
Affected Batch Details
The affected batch has number V2500425 and an expiry date of May 2028. It was first distributed on 28 November 2025, meaning some boxes may still be unopened. A total of 81,872 packs are potentially affected. The batch number and expiry date are printed on the side of the outer packaging.
What to Do
Dr Alison Cave, MHRA Chief Safety Officer, advises: "If you have been prescribed Sertraline 100mg tablets and have received batch number V2500425, please check the carton contains the right medication. If the blister strips inside are labelled Citalopram 40mg, contact your pharmacy as soon as possible. If they are labelled Sertraline 100mg, no further action is needed."
Patients who accidentally take citalopram instead of or alongside sertraline may experience heightened serotonergic side effects, including nausea, headache, sleep changes, and mild anxiety. Anyone discovering rogue strips should contact their pharmacy immediately.
Serotonin Syndrome Warning Signs
The MHRA urges patients to seek medical help immediately if they notice rapid heartbeat, nausea, headaches, or disrupted sleep patterns. These symptoms could indicate serotonin syndrome, which can be fatal. Other signs include high blood pressure, tachycardia (heart rate over 100 bpm), hyperthermia (body temperature around 40°C), dry eyes, excessive sweating, tremors, clonus (involuntary muscle contractions), muscle stiffness, and hyperreflexia.
Special Precautions
Patients over 65 or under 18, those with cardiac or liver conditions, or those who metabolise medicines differently should be monitored by a healthcare professional. Pharmacists are advised to contact affected patients' GPs for a treatment review and potential new prescription.
For more information, contact your pharmacy or the MHRA.
