Two Americans have reportedly died and three have been hospitalized after taking fake weight-loss injections, official data shows.
The cases have been recorded in a Food and Drug Administration (FDA) monitoring system known as FAERS, which is used to track side effects of medication.
They were reported system between July and September but have not been verified — though they were all submitted by the maker of Ozempic and Wegovy.
Booming sales has created shortages of those drugs in the past year, with consumers turning to counterfeit semaglutide, the active ingredient in them.
The two deaths were both in women who suffered from blood clots throughout the body — medically termed disseminated intravascular coagulation.
The above shows examples of fake and real Ozempic pens released by Novo Nordisk in June when it announced a fake pen had been spotted at a pharmacy in the US
The above is another example of the packaging for fake and real Ozempic. These images were released after a fake Ozempic was found for sale in a US pharmacy in June
Trish Webster, 56, from Australia, died from Ozempic after using the drug to drop 35lbs (16kg) over five months as she was trying to slim down for a dress for her daughter’s wedding
Among the patients hospitalized was a 66-year-old woman who suffered a seizure, another woman who suffered skin discoloration and bruising and a man who suffered a liver disorder.
In total there have been 28 reports of adverse effects from counterfeit semaglutide in the US to FAERS since March last year.
The drugs have been labeled as fake Ozempic or fake Wegovy in some cases.
All five reports of deaths and hospitalizations were submitted by Novo Nordisk, which makes Wegovy and Ozempic.
Four of the cases had been reported to the company by doctors and one had been reported by a consumer, which could include a patient, patient’s family or lawyer.
Manufacturers are obliged to report cases of serious adverse effects to the FDA.
Only one of the three hospitalizations mentioned Ozempic. All of the cases mentioned semaglutide.
Of the 28 reports of counterfeit semaglutide in the US, 14 — or half — were marked as ‘serious’.
A spokesman for the FDA said: ‘The FDA will investigate any report of suspect counterfeit Ozempic to determine the public health risks and the appropriate regulatory response.
‘The FDA remains vigilant in protecting the US drug supply from these threats.’
It comes amid concerns over counterfeit Ozempic in the US after regulators in the UK said fake versions of the drugs were leaving users in a coma.
UK regulators say they have already seized 369 potentially fake Ozempic pens since the start of the year.
A counterfeit Ozempic pen was found at a US pharmacy in June, triggering an alert from Novo Nordisk and the FDA.
Dr Shabbir Safdar, a pharmacist and executive director for the California-based Partnership for Safe Medicines, told DailyMail.com fake Ozempic drugs were often insulin shots that had been re-labeled.
‘If you do not need this but get a dose, it can cause hypoglycemia [low blood sugar] and strokes and, in some cases, a coma. So, it is basically like insulin poisoning.’
He warned that there were likely many other people who had been exposed to counterfeit Ozempic, but that their cases had not been reported.
‘Many counterfeit Ozempic victims do not know that they took a counterfeit,’ he said.
‘If you take an insulin pen that has been re-labeled as Ozempic and you don’t have a stroke, then you are unlikely to even know that you took a counterfeit.
‘You may think the medicine does not work for you or you didn’t take enough. For these patients, counterfeits are usually the last thought on their minds.’
Trish Webster, 56, pictured above with husband Roy, died after using Ozempic to lose some weight before her daughter’s wedding. The mother, from Australia, suffered side effects from the drug
Mrs Webster took a turn for the worse when she collapsed and a brown substance started to foam at her mouth. Her husband tried CPR and rolling her onto her side, but she was pronounced dead later that evening
The FDA’s system also shows there have been 63 deaths reported in patients while they were using Ozempic and one death in an individual who was using Wegovy.
The figures do not prove the deaths were related to the drug, but rather ‘reflect… the observations and opinions’ of those reporting them, according to the FDA.
Earlier this week it was revealed that a woman in Australia had died after taking Ozempic to slim down for her daughter’s wedding.
Trish Webster, 56, was not diabetic but took Ozempic for three months and then switched to Saxenda because of shortages.
She lost 35lbs (16kg) on the drugs but kept suffering from nausea, vomiting and diarrhea. She collapsed in January this year, however, with her husband doing CPR to try to save her but was pronounced dead later that evening.
Her family has called for a full inquiry into her death, saying they believe that the weight loss drugs were at least partly to blame.
Her husband Roy said: ‘She shouldn’t be gone, you know? It’s just not worth it, it’s not worth it at all.’
Deaths can be reported to FAERS by doctors, consumers, manufacturers, family members and others.
Medical documents will not be requested in the initial report, but those submitting one will be asked to give information on the adverse event, the drug they were using, their sex and age and clinical outcome.
Reports are reviewed and constantly monitored by investigators at the FDA to search for medication side effects that may have been missed during clinical trials. They can also be used to determine when to warn the public about counterfeit Ozempic.
The agency has previously used reports to add ileus to the warning label for Ozempic.
Both Wegovy and Ozempic use the drug semaglutide, which works by mimicking a hormone that tells someone they are full — causing them to eat less food and lose weight.
Ozempic contains about 1 milligram (mg) of the drug per shot, but Wegovy contains almost twice this amount at 2.4mg. They are administered as weekly injections.
Ozempic was approved for patients with diabetes in 2017, but became very popular in 2021 when doctors began prescribing it off-label to help non-diabetics lose weight. Wegovy was approved for patients in 2021 to help people lose weight who had one or more medical condition.
Source: | This article originally belongs to Dailymail.co.uk