MHRA maintains prescription-only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder
Following a public consultation and the review of a reclassification application from the manufacturer, the MHRA has decided that Aquiette 2.5mg Tablets will remain a prescription-only medicine.
The Medicines and Healthcare products Regulatory Agency (MHRA) has decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine. This follows a review of an application to reclassify the product and the conclusion of a public consultation. Patients can still access the medicine with a prescription from a qualified healthcare professional.
Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18 and 65, such as the urgent need to urinate and frequent urination without pain.
The consultation received an overwhelming number of responses and flagged concerns from patients, healthcare professionals and key stakeholders such as the Royal Pharmaceutical Society and the British Medical Association about the benefits and risks of reclassification. Patient responses also provided valuable insights and feedback on the impact of patient access.
The MHRA conducted a thorough review of safety data and sought independent advice from the Commission on Human Medicines (CHM). The review process considered all available evidence, including the responses received in the consultation, on the safety of Aquiette.
The assessment of the reclassification application concluded that a medical prescription continues to be required to ensure the safe use of Aquiette. An OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated. The decision to maintain Aquiette as a POM ensures that the medication is used safely and appropriately under medical supervision.
The MHRA is committed to listening to patient voices and continuously reviews data to improve access to medicines where it is safe to do so. Aquiette, and other medicines which contain oxybutynin, are safe to use and will still be available on prescription.
Dr Laura Squire, MHRA Chief Healthcare Quality and Access Officer, said:
“Last April we announced a consultation on whether Aquiette 2.5mg could be made available without a prescription.
“After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg Tablets for women with symptoms of overactive bladder (OAB).
“Independent advice from the Commission on Human Medicines (CHM), our own robust review of the available safety data and the overwhelming responses from our consultation were invaluable in helping us understand that Aquiette still meets the criteria for prescription-only status. An OAB diagnosis and the correct treatment for this condition require medical supervision.
“We remain committed to improving access to medicines where it is safe to do so and want to reassure patients that Aquiette is safe to use under medical supervision. It is important that patients continue taking their medication and speak to their GP or healthcare professional if they have any concerns about their prescription.”
Further information
- The full consultation response will be published in due course.
- The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.