Two Americans are believed to have died and three were hospitalized after taking fake weight-loss injections, official data shows.
The reports are included in the Food and Drug Administration’s (FDA) Adverse Drug Reaction Reporting System and date from July to September this year.
The two deaths both occurred in women who suffered from blood clots throughout the body – medically known as disseminated intravascular coagulation.
Hospitalized patients include a 66-year-old woman who suffered a seizure after taking counterfeit semaglutide, another woman who suffered skin discoloration and bruising, and a man who suffered from liver disease.
Since March of last year, there have been 28 reports of counterfeit semaglutide, the active ingredient used in Ozempic and Wegovy, in the United States. In some cases, the drugs are labeled Ozempic or Wegovy.
Both drugs have exploded in popularity in the United States, causing major shortages and prompting many patients to order online, increasing the risk of counterfeit or counterfeit versions of the drugs being sold by unscrupulous providers.
Above you can see a real Ozempic pen and a fake Ozempic pen confiscated in the UK. Regulators in the country say counterfeits leave users in a coma
Trish Webster, 56, from Australia, died of Ozempic after taking the drug to lose 16kg in five months while trying to lose weight for a dress for her daughter’s wedding
The reports were made to the FDA’s FAERS system, which monitors adverse drug reactions and reports of counterfeit drugs. Reports to the database are not reviewed and anyone can report an incident.
All five reports of deaths and hospitalizations were submitted by Novo Nordisk, which makes Wegovy and Ozempic.
Four of the cases were reported to the company by doctors and one was reported by a consumer, including a patient, the patient’s family or an attorney.
Fake Ozempic leaves British patient in coma
Health authorities have warned that fake versions of Ozempic are causing Britons to lose weight desperately and fall into comas.
Only one of the three hospitalizations mentioned Ozempic. Semaglutide was mentioned in all cases.
Of the 28 reports of counterfeit semaglutide in the US, 14 – or half – were classified as “serious”.
An FDA spokesperson said: “The FDA will investigate any report of suspected counterfeit Ozempic to determine the risk to public health and take appropriate regulatory action.
“The FDA remains vigilant to protect the U.S. drug supply from these threats.”
It comes amid concerns about counterfeit Ozempic in the US after regulators in the UK said counterfeit versions of the drug were putting users into comas.
British regulators say they have seized 369 potentially counterfeit Ozempic pens since the start of the year.
In June, a counterfeit Ozempic pen was found in a US pharmacy, prompting a warning from Novo Nordisk and the FDA.
Dr. Shabbir Safdar, a pharmacist and executive director of the California-based Partnership for Safe Medicines, told DailyMail.com that counterfeit Ozempic drugs are often rebranded insulin injections.
“If you don’t need it, but you get a dose, hypoglycemia can occur.” [low blood sugar] and strokes and in some cases a coma. So it actually looks like insulin poisoning.”
He warned that there are likely many other people who have been exposed to fake Ozempic but whose cases have not been reported.
“Many Ozempic counterfeit victims do not know they have brought a counterfeit,” he said.
“If you use an insulin pen that’s been rebranded as Ozempic and don’t have a stroke, you’re unlikely to even realize you’ve taken a counterfeit.”
“You may think that the medicine is not working for you or that you have not taken enough.” For these patients, counterfeiting is usually the last thing on their mind.”
Trish Webster, 56, pictured above with husband Roy, died after taking Ozempic to lose some weight before her daughter’s wedding. The mother, who is from Australia, suffered from the side effects of the medication
Mrs. Webster’s condition worsened when she collapsed and began foaming a brown substance from her mouth. Her husband attempted cardiopulmonary resuscitation and turned her onto her side, but she was pronounced dead later that evening
The FDA’s system also shows that 63 deaths were reported in patients using Ozempic and one death in a person using Wegovy.
The numbers do not prove that the deaths are related to the drug, but “reflect … the observations and opinions” of those who reported them, the FDA said.
Earlier this week, it was revealed that a woman in Australia died after taking Ozempic to lose weight before her daughter’s wedding.
Trish Webster, 56, did not have diabetes, but took Ozempic for three months and then switched to Saxenda because of shortages.
With the medication, she lost 16 kg, but still suffered from nausea, vomiting and diarrhoea. However, she collapsed in January this year while her husband performed cardiopulmonary resuscitation to save her. However, she was pronounced dead later that evening.
Her family has called for a full investigation into her death, saying they believe weight loss medication was at least partially 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 physicians, consumers, manufacturers, family members and others.
No medical documents are requested in the initial report, but those who submit one are asked to provide information about the adverse event, the medication they took, their gender and age, and the clinical outcome.
The reports are reviewed and continuously monitored by FDA investigators to check for drug side effects that may have been missed during clinical trials. They can also be used to determine when the public should be warned about counterfeit Ozempic.
The agency previously used reports to add ileus to the warning for Ozempic.
Both Wegovy and Ozempic use the drug semaglutide, which mimics a hormone that signals a person that they are full, causing them to eat less food and lose weight.
Ozempic contains about 1 milligram (mg) of the drug per injection, but Wegovy contains almost twice that amount: 2.4 mg. They are given as weekly injections.
Ozempic was approved for patients with diabetes in 2017, but gained popularity in 2021 when doctors began prescribing it off-label to help non-diabetics lose weight. Wegovy was approved in 2021 for use to help people with one or more medical conditions lose weight.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
