Oxybutynin to remain prescription-only medicine, following MHRA consultation

The medicines regulator said "overwhelming responses" to its consultation contributed to its decision against reclassification.
Pharmacist handing over a prescription to a customer

The Medicines and Healthcare products Regulatory Agency (MHRA) has said that Aquiette 2.5mg tablets (oxybutynin hydrochloride; Maxwellia), a medicine for overactive bladder (OAB) in women aged between 18 and 65 years, will remain as a prescription-only medicine (POM).

The regulator’s decision follows a consultation for views on the reclassification of Aquiette, which ran from 23 April to 13 May 2022, in response to which several pharmacy bodies said more information was needed about the drug’s potential side effects.

Oxybutynin hydrochloride works by relaxing a muscle in the bladder, which increases the bladder’s capacity to hold urine. The drug is available from a range of manufacturers, in doses of 2.5mg, 3.0mg and 5.0mg. The MHRA consultation applies only to Aquiette, after Maxwellia made the proposal to reclassify the product.

Announcing its decision on 11 May 2023, the MHRA said: “The consultation received an overwhelming number of responses and flagged concerns from patients, healthcare professionals and key stakeholders, such as the Royal Pharmaceutical Society (RPS) and the British Medical Association.”

It its response to the consultation, published in May 2022, the RPS said that it did not believe that oxybutynin was suitable to be switched from POM to Pharmacy (P) status. It cited “mounting evidence” implicating the active ingredient, oxybutynin, with “brain health harm, cognitive decline, the progression of dementia and greater mortality in those taking it”.

Responding to the MHRA’s decision, Claire Anderson, president of the RPS, said: “The RPS raised its concerns in MHRA’s consultation in 2022 on moving Aquiette from POM to P, so we welcome the news that the MHRA considered those concerns and has decided to keep Aquiette as POM.

There were many reasons why the RPS felt this medicine should remain prescription only, such as its potential to mask symptoms and delay diagnosis of serious conditions, the impact of its anticholinergic side effects on cognitive decline, the potential for dementia progression and it not being first choice for treatment in many areas.

“Pharmacists will always ensure patient safety remains at the forefront of providing care and the balance of benefit and harm does not support making Aquiette available as a pharmacy medicine.”

Laura Squire, chief healthcare quality and access officer at the MHRA, said: “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 OAB.

“Independent advice from the Commission on Human Medicines, 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.”

Last updated
The Pharmaceutical Journal, PJ, May 2023, Vol 310, No 7973;310(7973)::DOI:10.1211/PJ.2023.1.185453

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