News Category: Regulatory news
254 units of falsified Semaglutide detained in 2023 to-date, compared to 32 units throughout entire 2022
The Health Products Regulatory Authority (HPRA) today reminds the public of the serious health risks associated with sourcing prescription medicines online, as it reports a significant increase in the detention of products labelled as containing Semaglutide.
Semaglutide is the active substance in products such as OzempicTM, RybelsusTM and WegovyTM. Figures released by the HPRA show that 254 units of products claiming to contain Semaglutide were detained between January and September 2023, compared to just 32 units throughout the entirety of 2022. Products detained include vials of white powder or clear liquid labelled as containing Semaglutide and boxed pens being presented as a generic version of the product. The HPRA is concerned that these falsified products are being sold online by unscrupulous parties. It reminds the public that prescription medicines purchased online can contain harmful substances or incorrect dosages, thereby threatening your health and the effectiveness of any essential treatment you require.
Grainne Power, Director of Compliance with the HPRA, stressed the risks associated with buying prescription-only products from unverified and unregulated sources.
“Despite how they may be promoted or presented, it is not safe to purchase prescription medicines online and doing so puts your health at risk.”
Ms Power particularly appealed to members of the public who may be considering purchasing products online claiming to contain Semaglutide or presented as Ozempic, Rybelsus or Wegovy.
“The Semaglutide products that we have detained, including generic versions of pens as well as vials containing powder, are all falsified medicines. We have no information on where they were sourced or where, and under what conditions, they were manufactured. There is actually no authorised version of Semaglutide in powder form and any product of this nature promoted online is fake or falsified. Likewise, there are no generic forms of Semaglutide and any product of this nature promoted online is again fake or falsified. There is no way to know what these products actually contain or the strength of any dose provided. They could represent a serious risk to your health.”
“It is always best to seek advice from a healthcare professional about any health concerns or symptoms you may have. We strongly urge consumers to source their prescription medicines through the standard practice of accessing a prescription from your doctor, which is dispensed through your local pharmacy. Moving outside of this legal supply route presents a real risk to your health. Anyone using Semaglutide products that have been purchased online should stop using them immediately and contact a medical professional if they have concerns regarding their health.” Ms Power said.
The HPRA reminds members of the public they can report suspicious activities around the supply of Semaglutide and other health products to the HPRA, in confidence, by emailing reportacase@hpra.ie or by calling 01 634 3871 or 01 634 3431. Further information for consumers on the dangers of purchasing medicines online is available here: Dangers of buying prescription medicines online
For further information
Káno Communications Tel: (01) 6798 600
Kathryn Moley / Michael Watters (086) 733 4438 / (087) 399 6634
Notes to the editor
On 18 October 2023, the European Medicines Agency (EMA) issued an alert relating to pre-filled pens falsely labelled as the diabetes medicine Ozempic identified at wholesalers in Austria, Germany and the UK. The HPRA confirms that these pens have not been detected on the Irish market at this time.
Definition of a ''falsified medicinal product''
Any medicinal product with a false representation of;
(a) Its identity, including its packaging and labelling, its name or composition as regards any of its ingredients including excipients and the strength of those ingredients.
(b) Its source, including its manufacture, its country of manufacturing, its country of origin or its marketing authorisation holder.
(c) Its history, including records and documents relating to the distribution channel.