Tag: Medicines and Healthcare products Regulatory Agency

20 million illegal erectile dysfunction pills seized as MHRA warns against risky online buys

People are urged to avoid risky online buys and protect their health, as the MHRA seizes over 4.4 million doses of unlicensed erectile dysfunction medicines in 2025 alone

Nearly 20 million illegally traded erectile dysfunction pills have been seized in just five years – equivalent to a single dose for three in every four adult men in the UK – as the Medicines and Healthcare products Regulatory Agency (MHRA) warns people not to risk their health by buying unauthorised medicines online. 

Between 2021 and 2025, the MHRA’s Criminal Enforcement Unit seized around 19.5 million doses of erectile dysfunction medicines, including 4.4 million in 2025 alone, working closely with Border Force to intercept shipments and disrupt organised criminal networks.  

Many of the pills seized, enough to fill two double-decker buses, were illegally sold online and contained no active ingredient, the wrong dose, hidden drugs or toxic ingredients.  

Erectile dysfunction medicines remain one of the most frequently seized illegally traded medicines in the UK, with yearly seizures more than doubling since 2022. 

Dr Zubir Ahmed, Health Innovation and Safety Minister, said: “There should be no shame in talking about erectile dysfunction, but stigma and embarrassment are being exploited by criminals selling fake medicines that can be deadly.  

“We’re cracking down on crime and as a doctor, my message is simple: speak to your GP or pharmacist. They can offer safe, effective treatments and confidential advice, taking into account your health and any other medicines you take. 

“Don’t take a gamble with your health. If a medicine isn’t coming from a registered pharmacy, it isn’t safe – and it’s breaking the law.”

Andy Morling, Head of the MHRA’s Criminal Enforcement Unit, said: “These seizures show the sheer scale of the illegal market for erectile dysfunction medicines in the UK – and the risks people are taking without realising. 

“Any medicine not authorised for sale in the UK can be unsafe or ineffective and there is no way of knowing what is in them or the negative health effects they can have. These pills may look genuine, but many are potentially dangerous. These products may contain no active ingredient, the wrong dose, hidden drugs or toxic ingredients. 

“I’m incredibly pleased we’ve taken almost 20 million doses of unauthorised erectile dysfunction medicines off the streets, including 4.4 million last year alone, in what was a record-breaking year of total seizures for the MHRA. Each and every one of those products was potentially dangerous to the public.”

Alongside major seizures, the MHRA’s Criminal Enforcement Unit is stepping up action against online sellers. Working with internet service providers, they disrupted more than 1,500 websites and social media accounts illegally selling medical products to the public in 2025 and removed more than 1,200 social media posts during the year. 

Health risks of unauthorised medicines 

Despite erectile dysfunction being common, affecting around half of men aged 40 to 70, research suggests two in five men would avoid seeking medical advice, pushing some towards unsafe online sellers. 

The MHRA is warning people: if you buy erectile dysfunction medicines from unregulated websites, social media or messaging apps, you are gambling with your health. 

Unlicensed erectile dysfunction medicines can be especially dangerous for people with heart disease, high blood pressure, or those taking other medications, and can raise the risk of heart attack, stroke and dangerously low blood pressure. 

Public advice 

The MHRA urges people to: 

  • Avoid buying medicines from social media, messaging apps or unknown websites. Visit the #FakeMeds website for tools and resources to help you obtain medicines and medical devices safely online. 
  • Only use UK-registered pharmacies, including online pharmacies displaying the official green cross logo. For online pharmacies based in Great Britain you can check on the General Pharmaceutical Council’s (GPhC) website that it is properly registered. 
  • Speak to a GP or pharmacist about safe and effective treatment options. 

Anyone concerned about suspicious medicines or websites can report them through the MHRA’s Yellow Card scheme. 

MHRA crackdown on illegal ‘Botox’ after victims left seriously ill

More than 40 people hospitalised following suspected use of unlicensed botulinum toxin products

The Medicines and Healthcare products Regulatory Agency (MHRA) is warning criminals that they face prison as it cracks down on the illicit trade in unlicensed botulinum toxin products, commonly referred to as Botox, used in cosmetic procedures. 

The MHRA’s Criminal Enforcement Unit has launched a number of criminal investigations following a spike in hospital admissions believed to be linked to the use of unlicensed botulinum toxin products.

Between 4 June and 6 August 2025, 41 confirmed cases of botulism – a rare but potentially life-threatening condition causing paralysis – were reported across several regions in England, including the North East, East Midlands, East of England, North West, and Yorkshire and Humber. 

The Criminal Enforcement Unit has seen evidence that some sellers and practitioners – often untrained – are obtaining unlicensed botulinum toxin products illegally and offering injections in unsafe, unregulated settings.

The treatments are being delivered in informal settings such as domestic bedrooms and kitchens, hair salons, and through mobile beauty services. Members of the public are often lured in by adverts on social media promising quick, cheap results. 

The Criminal Enforcement Unit is investigating the illegal trade in these products. Anyone caught selling or supplying unlicensed botulinum toxin faces up to two years in prison and unlimited fines under the Human Medicines Regulations 2012. 

Andy Morling, Head of the MHRA’s Criminal Enforcement Unit, said: “Criminals are exploiting the popularity of cosmetic treatments by peddling dangerous, unlicensed products, putting profit before safety.

“Anyone involved in the supply of unlicensed botulinum toxin – whether through organised networks or informal sales from kitchen tables, hair salons, or via social media – is breaking the law and endangering lives. The 41 individuals we’ve seen between June and August left seriously ill represent the devastating human cost of this trade. 

“We are working across the country to identify those responsible, seize illegal products, and bring cases to court. We use the full range of our enforcement powers and techniques to shut down these operations and bring offenders to justice.” 

This crackdown is part of the MHRA’s wider work to disrupt illegal botulinum toxin supply. Since May 2023, the Criminal Enforcement Unit, working closely with its partners in Border Force, has seized more than 4,700 vials of unlicensed botulinum toxin both at the border and inland.  

Almost all of the seized products originated in South Korea, including brands such as Botulax, reNTox, Innotox, and Toxpia, which are not authorised for sale in the UK. 

The Criminal Enforcement Unit also works with social media companies to remove illegal listings and disrupt criminal networks advertising unlicensed botulinum toxin. 

Understanding the health risks 

Botulism caused by botulinum toxin in cosmetic procedures is rare, but can be life-threatening. Symptoms can take up to four weeks to develop and may include difficulty swallowing, slurred speech and breathing difficulty. In severe cases, patients may require mechanical ventilation and intensive care treatment. 

Anyone who has recently received a botulinum toxin treatment and develops any of these symptoms should seek medical help immediately via NHS 111 or emergency services. 

Health Minister Stephen Kinnock said: “No one should have to suffer serious illness or risk their life because criminals are flooding the market with unsafe products.  

“This government is determined to crack down on cosmetic cowboys who exploit vulnerable consumers seeking cut-price treatments outside suitable medical settings. Through the MHRA’s criminal investigations and our new regulations, we’ll use the full force of the law against those who supply unlicensed medicines. 

“I would urge anyone considering a cosmetic procedure to consider the risks and find a reputable, insured, and qualified practitioner.”

MHRA Chief Safety Officer Dr Alison Cave said: ““Public safety is a top priority for the MHRA. Botulinum toxin is a prescription-only medicine and should only be sold or supplied in accordance with a prescription given by an appropriate prescriber such as a doctor or other qualified healthcare professional. 

“Buying botulinum toxin in any other circumstances significantly increases the risk of getting a product which is either falsified or not licensed for use in the UK. This means that there are no safeguards to ensure products meet the MHRA’s standards for quality and safety. As such, they can have life-threatening consequences for the people who take them. 

“If you are offered botulinum toxin without a medical consultation, in an informal setting, or at a price significantly below usual rates, this should be treated as a warning sign. Lower cost does not mean safe; it may put your health at risk and could lead to hospitalisation.” 

How to protect yourself and report concerns 

Licensed botulinum toxin products undergo rigorous testing and quality controls to ensure they contain the correct active ingredient at safe concentrations. Legitimate treatments should only be carried out by qualified healthcare professionals in proper clinical settings with appropriate emergency equipment available. 

Before any treatment, verify that your practitioner is medically qualified and registered with their professional body. Check that products being used are licensed in the UK by asking to see packaging and checking batch numbers. Be suspicious of unusually cheap prices, treatments offered in domestic settings, or practitioners who cannot provide proper credentials. 

The MHRA urges anyone who experiences side effects or complications after a cosmetic procedure to report them via the Yellow Card scheme at:

https://yellowcard.mhra.gov.uk/. 

llegal medicines worth more than £30 million seized in the UK in 2023

The Medicines and Healthcare products Regulatory Agency (MHRA), working with law enforcement partners, seized more than 15.5 million doses of illegally traded medicines with a street value of more than £30 million during 2023.

his includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical products.

Last year’s seizures included prescription-only anti-anxiety medicines, opioids and sleeping pills and falsified and unlicensed lifestyle products such as erectile dysfunction and hair loss medications, as well as a small number of aesthetic products such as Botox and semaglutide-containing ‘weight loss’ products.

Working with partners, the MHRA also disrupted more than 12,000 websites illegally selling medical products to the public and shut down almost 3,000 social media profiles during the year.

The MHRA works with many online marketplaces, social media platforms and technology providers, as well as a wide range of law enforcement agencies at home and abroad to investigate and remove potentially harmful medical products that are offered illegally to the public. 

Support and advice provided by the MHRA to online marketplaces resulted in the successful removal of more than half a million unregulated prescription medicines, over-the-counter medicines and medical devices before they could even be offered for sale to the public.

Andy Morling, MHRA Deputy Director (Criminal Enforcement), said: Public safety is our number one priority. Our Criminal Enforcement Unit works hard to prevent, detect and investigate illegal activity involving medicines and medical devices, to protect people and defeat this harmful trade.

“This year, working with partners across public and private sectors, our efforts have led to more medicines seizures than ever, custodial sentences for offenders, the removal of criminal profits and considerable success in disrupting the trade online.

“We would urge everyone to think very carefully before buying medicines they see online and to take the necessary steps to assure themselves the seller is legitimate. Buying powerful medicines from illegitimate sellers poses a real and immediate danger to your health, as you have no idea what they might actually contain. 

“If you suspect that you have seen illegal products being sold online, you can help us take action by reporting your concerns through our Yellow Card scheme.

The dangers of unlicensed medicines

If a medicine is unlicensed, it will not have been assessed by the MHRA for its safety, effectiveness or the quality of its manufacturing and distribution processes. Anyone buying such a product cannot be sure what it contains or whether it will cause them harm.

In the courts

The sale of medicines and medical devices is strictly controlled in the UK, with certain products only permitted for sale through registered pharmacies or supplied on prescription from a qualified healthcare professional.

Last year, six MHRA investigations resulted in significant custodial sentences for many of those convicted.   These prosecutions followed detailed investigations, the seizure of millions of doses of medicines and the removal of hundreds of thousands of pounds of criminal profits. 

MHRA safety advice when buying medicines online

Be careful when buying medicines online

Medicines are not ordinary consumer goods and their sale and supply is tightly controlled. Websites operating outside the legal supply chain may seem tempting, for example, offering a prescription medicine without a prescription. Not only are these sites breaking the law – they are putting your health at risk. 

Criminals use a variety of techniques to sell medicines illegally online. Some are sold using websites designed to look like legitimate pharmacies or online retailers, while others might be advertised via online marketplaces or social media sites.

Visit the #FakeMeds website for tools and resources to help people purchase medicines or medical devices safely online.

Anyone who suspects that their product is fake is encouraged to report it directly to the Yellow Card scheme, through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card. 

JCVI advises use of additional bivalent vaccine for autumn booster campaign

Following on from the previous advice on which vaccines should be used in this year’s autumn booster programme, the Joint Committee on Vaccination and Immunisation (JCVI) has updated its published advice to include an additional bivalent vaccine now approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

Studies indicate the Pfizer-BioNTech bivalent vaccine produces a marginally higher immune response against some variants than the Pfizer-BioNTech mRNA Original ‘wild-type’ vaccine. The clinical relevance of these small differences is uncertain.

‘Bivalent’ vaccines have been developed by global manufacturers since the emergence and dominance of the Omicron variant. These vaccines are targeted against antigens (substances that induce an immune response) from 2 different COVID-19 strains, or variants.

All of the available booster vaccines offer very good protection against severe illness from COVID-19. As more vaccines continue to be developed, the committee will consider their use in the autumn programme.

Professor Wei Shen Lim, Chair of COVID-19 immunisation on the JCVI, said: “It is very encouraging that more vaccines continue to become available and we now have another option to add to the vaccines already advised for the autumn booster campaign.

“Winter is typically the time of greatest threat from respiratory infections. We strongly encourage everyone who is eligible to have their booster vaccine this autumn when it is offered. This is our best defence against becoming severely ill from COVID-19.”

Pfizer/BioNTech bivalent COVID-19 booster approved by UK medicines regulator

A second, “bivalent” vaccine was yesterday approved as a booster by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.

In each dose of the booster vaccine, ‘Comirnaty bivalent Original/Omicron’, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1).

The MHRA’s decision is based on data from a clinical trial which showed that a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against both Omicron and the original strain. Safety monitoring showed that the side effects observed were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, and no new serious safety concerns were identified.

Dr June Raine, MHRA Chief Executive said: I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.

“Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against COVID-19 variants.

“We have in place a comprehensive safety surveillance strategy for all UK-approved COVID-19 vaccines, and this will include the updated booster we approved today.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said: “Following an independent review of the safety, quality and effectiveness of the vaccine, the Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group supports the MHRA’s decision.

“As with any medicinal product, including vaccines, it is important to continually monitor effectiveness and safety when it is deployed, and we have the relevant processes and expertise in this country to do that.

“The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme.”