Following MHRA consultation, oxybutynin will remain a prescription-only drug


The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Achiette 2.5 mg tablets (oxybutynin hydrochloride, Maxwellia), a drug for the treatment of overactive bladder (OAB), for women aged 18 to 65 as a prescription-only drug. announced that it would be left as (Pom).

The regulatory decision follows consultations seeking opinion on the reclassification of Aquiet, which took place from April 23 to May 13, 2022, in response to multiple pharmacy associations reviewing the drug’s potential He said he needed more information about side effects.

Oxybutynin hydrochloride works by relaxing the muscles of the bladder, increasing the ability of the bladder to hold urine. The drug is available from various manufacturers in doses of 2.5mg, 3.0mg and 5.0mg. The MHRA consultation only applies to Aquiette following Maxwellia’s proposal to reclassify the product.

Announcing the decision on 11 May 2023, the MHRA said: “This consultation has received an overwhelming number of responses and concerns from patients, health professionals and key stakeholders such as the Royal Society of Pharmaceutical Sciences (RPS) and the British Medical Association. was pointed out,” he said.

In a response to this consultation, published in May 2022, RPS said it did not believe it was appropriate for oxybutynin to be switched from POM to pharmacy (P) status. The report said there was “growing evidence” that the active ingredient, oxybutynin, was associated with “brain health harm, cognitive decline, advanced dementia and increased mortality in those who took it.” there is,” he said.

Following the MHRA’s decision, RPS Chairman Claire Anderson said: “RPS expressed concerns during the 2022 MHRA consultations regarding the transition of Aquiette from POM to P. We therefore welcome the news that the MHRA has considered those concerns and made the following decisions.” he keeps as POM.

There are many reasons why RPS believes this drug should be available only by prescription. It may mask symptoms and delay diagnosis of a serious condition, the impact of anticholinergic side effects on cognitive decline, the possibility of dementia progression, and this drug is not the first. Treatment options are available in many areas.

“Pharmacists ensure that patient safety is always at the forefront of care delivery and that the balance of benefits and harms is not what makes Acchiette available as a pharmacy drug.”

Laura Squire, MHRA Chief Quality and Access Officer, said, “After incorporating input from many of the patients and health care professionals we have worked with, we are pleased to announce the availability of Acchiette 2.5mg tablets for women with symptoms of OAB. We have decided to reject the reclassification.” .

“Independent advice from the Human Medicines Board, our own in-depth review of available safety data, and overwhelming responses from our consultations ensure that Achiette still meets the criteria for prescription-only status. It was invaluable to understand that

“The diagnosis of OAB and the correct treatment of this condition require medical supervision.”



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