MHRA Issues New Regulations on OTC Stimulant Laxatives

 

New regulations have been introduced governing the sale of over-the-counter stimulant laxatives following a review by the Medicines & Healthcare Products Regulatory Agency (MHRA).

 

The MHRA launched the safety review after the BBC TV Watchdog programme highlighted the risk of the misuse of over-the-counter laxatives by people with eating disorders in a 2014 investigation.

This was followed by calls from eating disorder charity Beat for a change in regulations around the sale of the product to protect eating disorder suffers.

Beat estimates 80% of those affected by eating disorders in the UK have used laxatives to lose weight.1

Announcing the review, the MHRA said OTC stimulant laxatives have been under close review for some time. Previous recommendations have included the addition of warnings that laxatives do not aid weight loss and that taking them for a long time may be harmful. However, these were not consistently added to all stimulant laxatives. To read the full review click here

The government agency agreed that stronger warnings should be added to products emphasising that ‘taking laxatives regularly for a long time is harmful and they do not aid weight loss’.

Senna Tablets

 

Patients will need to know

  • Why this new legislation is in place

  • How pack sizes have changed

  • That Care Senna 7.5mg Tablets 12 Years Plus (60 and 100 tablets) are now only available in pharmacies and can only be sold by or under the supervision of a pharmacist.

  • An age restriction now applies

  • Packs are limited to two short treatment courses (20 tablets) at a time and if patients require a larger pack size they will need to speak to the pharmacist.

  • To carefully read the Patient Information Leaflet before use and ask for help and advice if they require further information

So, what is the new legislation and how will it affect pharmacy?

The new MHRA legislation covering the sale of OTC stimulant laxatives is as follows:

  • Pack sizes: 100, 60 and 20 tablets remain but the larger pack sizes (100s and 60s) have been re-classified as P products. 20 tablet packs remain GSL
  • Customers must be aged 18 or over to purchase Care Senna 7.5mg Tablets Adults (20 tablets)

  • GSL products will be limited to a pack size of two short treatment courses (20 tablets)

  • Additional warnings on all patient information leaflets and packaging. These are ‘Do not help with weight loss’ and ‘Overuse can be harmful’.

The Care Senna Tablets range is still available in packs of 20, 60 and 100 tablets.

Care Senna 7.5 mg Tablets 12 Years Plus (60 and 100 tablets) now have a P classification meaning they can only be sold from a registered pharmacy by a pharmacist or person acting under the supervision of a pharmacist. Care Senna 7.5mg Tablets Adults (20 tablets) remains a GSL product.

There is now a number of new regulations covering the sale of all pack sizes.

The Patient Information Leaflet and packaging has always stated laxatives do not affect the number of calories absorbed from food and do not help with weight loss. Previously the age restriction on all Care Senna Tablets was for children over 12.

Pharmacy staff will be on the front line of informing and educating patients about these changes. Care is supporting pharmacies to do this by providing both HCP and consumer information materials to make the process as straight-forward as possible.

We will be on-hand to guide pharmacy staff and consumers through these new OTC laxative regulations.

Care brand manager Emma Boyle said: “Patient safety is paramount, and Care is working closely with all the relevant authorities to ensure its products adhere to the new classifications and legislation introduced by the MHRA.”

“Care is now rolling-out a programme of literature to ensure both our pharmacy customers and consumers are aware of the changes and how they will affect them. Emails and information leaflets are being sent to our pharmacy customers to ensure they are aware of the new legislation as well as providing them with information to hand out to patients.”

Beat continues to campaign for better education around the dangers of laxative abuse.

According to the National Eating Disorders Association, laxative misuse can have serious health consequences by causing strain to internal organs.2 These include severe dehydration which can lead to kidney damage and a disturbance of electrolyte and mineral balances which can harm the heart and colon. In extreme cases it can lead to cardiac arrest, says the Royal College of Psychiatrists.3

Grey Angle