Medicines regulator to publish review into safety of OTC laxatives

Exclusive: Concerns about stimulant laxatives’ potential for abuse, particularly among people with eating disorders, was the driving force behind the four-year review.

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Exclusive: The Medicines and Healthcare products Regulatory Agency (MHRA) is to publish the results of a four-year review into the safety of over-the-counter (OTC) stimulant laxatives, a spokesperson has confirmed.

The class review, which began in September 2016, was started in response to concerns about the potential for abuse and misuse of OTC stimulant laxatives, particularly among people with eating disorders.

A spokesperson for the MHRA said the length of the review was due to the need for the MHRA to consider and assess all available evidence, including consulting professional experts, patients and the public in order to come to a “robust position”.

They added that the review would be published in the next few months.

“All medicines, including those bought over the counter, must be used responsibly and as advised in the information provided with the medicine,” they said.

“Patient safety is our highest priority and we work to make sure the benefits of medicines outweigh the risks. This includes assessing whether regulatory action is needed to minimise the potential for abuse.”

Joan Brunton, consultant psychiatrist and clinical director of eating disorders at Priory Healthcare, which operates mental health facilities across the UK, said she supported a return to prescription-only drugs for laxatives or, “at the very least pharmacist-controlled [supply] with, say, an upper limit of five days’ supply per packet”.

She explained that around half of patients with eating disorders misuse stimulant laxatives to varying degrees.

“They are easy to obtain and administer. Because they are available in supermarkets patients often see them as harmless and mild.

“[But] they can be very dangerous in the short term, affecting the heart and kidneys and, in the longer term, they can lead to chronic constipation and bowel prolapse,” she added.

The National Pharmacy Association (NPA) said that a ban on OTC sales of stimulant laxatives would be “disproportionate”. 

In a statement issued to The Pharmaceutical Journal, the NPA said: “This is a concern, but pharmacists are aware of this risk and seek to intervene to ensure safe supply and advice is given where necessary.

“We would not support a ban on OTC sales which would be disproportionate and would limit safe access to medicines.”

In 2017, the Royal College of Psychiatrists released a position statement, written by Brunton, about laxative abuse in eating disorders and highlighted that constipation was common in eating disorders, such as anorexia nervosa, as only small amounts of food are ingested and gastric motility slows down.

The statement said that use varied from “occasional, just over the recommended guidelines to those sufferers who take 100+ tablets per day”.

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Citation
The Pharmaceutical Journal, February 2020;Online:DOI:10.1211/PJ.2020.20207696