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MHRA reclassifies erectile dysfunction tablets for OTC pharmacy purchase

The medicines watchdog has reclassified an erectile dysfunction medication so that it can be bought over the counter at a pharmacy without a prescription, it has announced.

Cialis Together (10mg tadalafil citrate) tablets “will be available to purchase from pharmacies” once marketed by the manufacturer, the Medicines and Healthcare products Regulatory Agency (MHRA) said yesterday (March 14).

It follows the product's switch from a prescription-only medicine (POM) to a pharmacy-only (P) medicine.

In future, this means that the medicine could be available to men over 18 with erectile dysfunction to buy over the counter without a prescription, the MHRA added.

Read more: Boots pharmacies to sell own-brand Viagra and vaginal health products

A spokesperson for manufacturer Sanofi told C+D yesterday that the tablets’ launch “is planned for the second half of 2023”.

“The Cialis Together recommended retail price points will be communicated closer to launch,” they added.


Pharmacist “discussion”


Once marketed, Cialis Together will be sold from pharmacies after a “discussion” with a pharmacist, who “will be able to determine whether treatment is appropriate”, the MHRA said.

Pharmacists will also be able to give advice on usage, potential side effects and whether a GP consultation is required, it added.

They will have access to training materials and a checklist that will enable them to advise men on whether these tablets are appropriate and safe for them to use, it said.


One tablet a day, eight in a pack


Cialis Together will be available through pharmacies without a prescription with a maximum dose of one tablet each day and a maximum pack size of eight tablets, the medicines watchdog said.

Other medicines containing tadalafil will still be available to obtain on prescription, it added.

Read more: Viagra Connect sales soar following pharmacy launch

Erectile dysfunction treatments have been available to purchase in pharmacies since 2018, when Viagra Connect (sildenafil 50 mg tablets) was first reclassified with a P legal status, the MHRA said.

However, this was the first application for a tadalafil product to be available as a pharmacy medicine, it added.


Not for those with cardiovascular disorders


The decision followed advice from the Commission on Human Medicines, as well as a “reassuring assessment of the safety” of the medication, the MHRA said.

However, Cialis Together “will not be sold to those with severe cardiovascular disorders; at high cardiovascular risk; severe kidney or severe liver failure; or taking certain interacting medicines”, the medicines watchdog added.

Use of the treatment in these groups of men must instead “continue to be under the supervision of a doctor”, it said.


“Popular target for criminals”


Meanwhile, the MHRA warned that erectile dysfunction medicines such as Cialis Together “are a popular target for criminals selling unlicensed and counterfeit medicines”.

Read more: UK gang members jailed for part in illegal sale of prescription meds worth £3.7m

“Every year, the MHRA and UK Border Force seize millions of pounds worth of unlicensed and counterfeit erectile dysfunction medicines,” it said.

It comes as three UK members of an “international criminal gang” were this week sentenced to jail for involvement in the illegal sale of prescription medicines valued at £3.7 million – including various erectile dysfunction drugs.


“Good news for men’s health”


MHRA chief officer for healthcare, quality and access Dr Laura Squire said that the decision “is good news for men’s health”.

“Men who suffer from erectile dysfunction will be able to obtain this treatment safely and conveniently from their local pharmacy without a prescription, which not only gives them greater control over their choices but increases awareness of erectile dysfunction,” she added.

Read more: Generic Viagra reclassified from POM to P medicine

The Sanofi spokesperson told C+D that the MHRA’s reclassification of Cialis Together 10mg tablets “represents an important milestone in Sanofi’s ongoing commitment to bring health into the hands of more people”.

But they stressed that the medication will only be available “under the supervision of, and following a consultation with, a pharmacist”.

According to NHS Inform, erectile dysfunction is a very common condition, with an estimated half of all men between the ages of 40 and 70 having it to some degree.

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