Patient safety concerns over use of the medicine propranolol for generalised anxiety have prompted leading experts to call for a review of the medicine’s safety information, particularly around overdose, self-harm and suicide risk.

The Royal College of Pharmacy and the Royal College of Physicians Medicines Safety Joint Working Group, in collaboration with the National Poisons Information Service, has written to the Medicines and Healthcare products Regulatory Agency (MHRA) requesting updates to the medicine’s Summary of Product Characteristics.

The request is based on evidence and clinical experience which indicate that the current licensed indication for propranolol in generalised anxiety is problematic for a number of reasons:

• There is no proven evidence that propranolol is effective in the treatment of generalised anxiety disorder.
• Propranolol poisoning is life-threatening, difficult to treat and is associated with a significant number of deaths.
• Prescribing for propranolol in general practice is increasing*, partly because the medicine is perceived to be relatively safe.
• Patients at increased risk of overdose, including those taking antidepressants or with a history of overdose, continue to be prescribed propranolol.

The letter to the MHRA is part of a wider programme of activity led by the Royal College of Pharmacy (RCPharm) and Royal College of Physicians (RCP) Medicines Safety Joint Working Group to improve understanding of medication-related risks and support safer prescribing across the healthcare system.

Kate Ryan, Joint Chair of the RCP/RCPharm Medicines Safety Joint Working Group, said:

“Patient safety is at the heart of this work. While propranolol remains an effective treatment for many patients, its use for anxiety presents challenges. We are concerned about the serious consequences of overdose, particularly for vulnerable individuals.”

Dr Zuzanna Sawicka, Joint Chair of the RCP/RCPharm Medicines Safety Joint Working Group, said:

“We are asking the MHRA to review whether the current indication for generalised anxiety disorder and associated safety information remain appropriate. Strengthening awareness of these risks among healthcare professionals and patients could support safer prescribing decisions and help prevent avoidable harm.”

The joint Medicines Safety Group will also be supporting an NHS England Patient Safety Team short-life working group examining this issue, including consideration of non-pharmacological and supported self-care options for patients.

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