As a precautionary measure,\u00a0the Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is\u00a0contacting\u00a0certain\u00a0individual\u00a0patients\u00a0to make them aware\u00a0of\u00a0a small possibility that they may have been dispensed a\u00a0fake\u00a0Mounjaro (tirzepatide) KwikPen 15mg solution for injection\u00a0for weight-loss management from\u00a0The Private\u00a0Pharmacy Clinic in Birmingham.\u00a0<\/p>\n
All the affected fake pens\u00a0identified\u00a0to date are 15mg pens with the batch\u00a0number: D873576\u00a0dispensed by this pharmacy.\u00a0<\/p>\n
This is a legitimate batch number for genuine Mounjaro\u00a0KwikPen\u00a07.5mg, and pens at this strength are not\u00a0impacted.\u00a0<\/p>\n
Dr\u00a0Alison Cave, Chief Safety Officer at the MHRA said:\u00a0\u00a0<\/p>\n
\u201cCheck the batch number and strength of your\u00a0KwikPen.\u00a0If you have one of the affected pens, stop using it straight away.\u00a0Please report it to the MHRA\u00a0by emailing info@mhra.gov.uk<\/a>.\u00a0Please include \u201cMounjaro Pens\u201d in the subject line.\u00a0Keep the pen in a safe place.\u00a0\u00a0<\/p>\n \u201cIf you have administered injections using the pen already, please be reassured that, based on the cases reviewed to date, the risk to you is low.\u00a0Testing has confirmed that the identified fake pens do\u00a0contain\u00a0tirzepatide,\u00a0the active substance in Mounjaro, but because the manufacturing conditions are unknown, we cannot confirm that the contents are sterile.\u00a0\u00a0\u00a0<\/p>\n \u201cIf you are unsure of how to\u00a0identify\u00a0the\u00a0pen,\u00a0or\u00a0are unsure on whether you have administered an affected\u00a0product\u00a0and have any questions,\u00a0please speak to a healthcare professional.\u00a0<\/p>\n \u201cIf you suspect that\u00a0you\u2019ve\u00a0had a side effect\u00a0as a result of\u00a0using these\u00a0affected pens, or suspect\u00a0it\u2019s\u00a0not a genuine product, or have a defective pen,\u00a0you can report it to our\u00a0MHRA\u00a0Yellow Card scheme. It is important you do not try to extract any\u00a0of this medicine\u00a0if a pen is defective in any way.\u00a0<\/p>\n \u201cIf you have a 15mg pen and the batch number is different to D873576, please continue to take the medication as directed by your prescriber.\u201d\u00a0<\/p>\n As this is an injectable product, if its contents are not sterile, there is potential for infection.\u00a0Possible signs\u00a0of infection include:\u00a0\u00a0<\/p>\n Redness,\u00a0swelling\u00a0or warmth around the site of the injection\u00a0\u00a0\u00a0<\/p>\n Pain or discomfort around the site of injection\u00a0\u00a0\u00a0<\/p>\n Fluid leakage from the site of injection\u00a0\u00a0\u00a0<\/p>\n Mild fever, chills, fatigue, and sore throat\u00a0\u00a0<\/p>\n There may also be a risk of allergic reactions to the contents of the pen. Symptoms may include a rash, itching or difficulty breathing.\u00a0<\/p>\n If\u00a0patients\u00a0experience any symptoms of an infection or allergic reaction,\u00a0they should\u00a0seek urgent medical attention.\u00a0<\/p>\n The MHRA has not received any reports of patients requiring treatment after taking\u00a0these\u00a0fake\u00a0medicines.\u00a0The issue was\u00a0identified\u00a0due to faults with the pens, where in all but one case the dose knob came off while in use.\u00a0\u00a0<\/p>\n The MHRA was notified of these counterfeits by the manufacturer of the genuine product, Eli Lilly and Company Limited, which has\u00a0received five reports of faulty pens.\u202f\u202f\u00a0<\/p>\n The General Pharmaceutical Council have served a \u2018notice of conditions<\/a>\u2019 on the pharmacy involved. The MHRA is continuing with their ongoing investigations\u00a0<\/p>\n A Drug Safety Update (DSU)\u00a0for healthcare professionals\u00a0has also been published<\/a>, which includes detailed advice on\u00a0identifying\u00a0the affected product and managing patients who may have received it.<\/p>\n Notes to editors:\u00a0<\/p>\n Fake\u00a0medicines are illegally produced products that may\u00a0contain\u00a0incorrect ingredients, no active ingredients, or harmful substances.\u00a0Although it may appear similar to the real medicine, a fake medicine has not been manufactured to the correct standards. As a result, we cannot guarantee that the medicine is safe, works properly, or is of the right quality.\u00a0<\/p>\n Anyone who suspects they have received a counterfeit medicine or has noticed any fault with a\u00a0weight-loss\u00a0pen should report it directly to the Yellow Card scheme, either through the website (https:\/\/yellowcard.mhra.gov.uk\/<\/a>) or by searching the Google Play or Apple App stores for MHRA Yellow Card.\u202f\u00a0<\/p>\n Patients should be reminded on the MHRA guidance on safe use of GLP-1 medicines:\u00a0GLP-1 medicines for weight loss and diabetes: what you need to know – GOV.UK<\/a>\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u202fis responsible for\u202fregulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.\u202f\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u00a0<\/p>\n