DailyMail.com reveals that weight loss injections such as Ozempic are responsible for 162 deaths in the US.
One of the victims was a 45-year-old woman who choked on her own vomit while taking Mounjaro, a competing drug that works in a similar way.
Another case involved a 23-year-old man who died from vomiting, nausea and a rapid heart rate after taking Wegovy.
There is no evidence that the injections were a direct result of the deaths, but experts say the reports indicate there are cases where they likely played a role.
The deaths were recorded in the FDA’s FAERS database, which is used to monitor the safety of drugs after they are approved and marketed.
The graph above shows deaths associated with semaglutide and tirzepatide by year. Semaglutide is the active ingredient in Ozempic and Wegovy, while tirzepatide is used in medications such as Zepbound. Yellow is used for 2024 to indicate that the data is incomplete
The number of deaths involving weight loss drugs has increased by 40 percent in the past six months, with 117 deaths reported to the system during that period.
The FAERS system also records side effects of medications, or when someone experiences a reaction after taking a medication.
Reports can be submitted by nurses, physicians, manufacturers and patients themselves.
As with deaths, the reports do not prove that a reaction was directly caused by a drug.
For example, someone might take a medication and then get food poisoning, which causes stomach problems.
Since 2018, the system has recorded 62,000 reactions to weight-loss drugs containing semaglutide and tirzepatide, such as Ozempic and Mounjaro, in the US.
The vast majority of these, 46,000, were recorded after 2022, following an increase in use of the drug as more vaccinations were approved.
Ozempic first came on the market in 2018, when it was approved for diabetics, but it was often prescribed off-label for weight loss.
Sister drug Wegovy, which uses slightly higher doses, was approved for weight loss in June 2021.
Eli Lilly’s drug Mounjaro, which contains tirzepatide, was approved for diabetics in May 2022, but has also been used off-label to help patients lose weight.
And in November 2023, the company’s drug Zepbound was approved for patients looking to lose weight.
About 1.7 percent of Americans, or 5.6 million people, will be prescribed a weight loss medication in 2023, according to a data analysis from healthcare company Epic Research.
That’s forty times as many as five years earlier, when it was estimated that only a few hundred thousand Americans used the drug.
Surveys this year show that six percent of American adults, or 15.5 million people, have now tried a weight-loss drug.
In FAERS, a total of 10,000 responses were classified as “serious,” or if a patient had been hospitalized or had experienced a life-threatening event.
Among the new cases reported in the past six months is a 30-year-old man who took Ozempic and was admitted to hospital with pancreatitis, a serious condition in which the pancreas becomes inflamed and causes abdominal pain that some patients describe as “worse than childbirth.”
His case was reported in June, but occurred in April last year.
And in another case that occurred in May of this year and was reported in June, a 49-year-old woman was hospitalized after experiencing mania and a sudden increase in blood pressure while taking Ozempic.
Juanita Gantt was found unconscious by her husband Robert one day in October 2023 and rushed to the hospital, where she was discovered to have a severe case of colitis, which required the removal of her colon.
Australian Trish Webster, 56, pictured above, died after taking Ozempic to lose some weight before her daughter’s wedding
In total, the FDA system has recorded 162 deaths since 2018 among people taking successful weight loss drugs.
Of these, 94 were associated with semaglutide, the active drug in Ozempic and Wegovy.
The remaining 68 were linked to tirzepatide, the drug used in the weight-loss vaccines Mounjaro and Zepbound.
Of the 64 deaths recorded in 2023, 30 were related to semaglutide and 32 to tirzepatide.
In 2023 and 2024, tirzepatide was associated with almost twice as many adverse events as semaglutide, including a 48-year-old woman who experienced serious bleeding at the injection site and a 26-year-old man who reported lower abdominal pain.
In 2023, there were 6,300 reactions related to semaglutide, compared to 15,500 related to tirzepatide.
So far in 2024, 4,710 reactions have been linked to semaglutide, but 19,450 to tirzepatide.
Dr. Adam Rubinstein, a plastic surgeon in Miami, Florida, said he was “surprised” by the death rates. He said he rarely hears about serious complications in patients taking the drugs.
“The only significant complaint I’ve heard anecdotally is pancreatitis,” he told DailyMail.com. “These numbers are very surprising to me.”
He added: ‘A lot of these side effects are probably quite loosely related to the medication, because this number seems quite high.’
He also said it’s possible that tirzepatide causes more reactions than semaglutide because it is “slightly more potent” and reportedly causes slightly more weight loss.
“If there is greater weight loss, then you would expect there to be more side effects,” he said.
This week, a Pennsylvania woman shared her near-death experience while taking Ozempic.
62-year-old diabetic Juanita Gantt responded well to medication for months until she suddenly fell asleep at home and was found unconscious by her husband.
Doctors discovered that part of her intestine had died from a condition called ischemic colitis, which required the removal of her colon. She later went into cardiac arrest.
The woman will now have to use a drainage bag when she goes to the toilet for the rest of her life. This is a bag that is used to collect waste from the intestines when the normal way is no longer working. She says she would not have needed it if she had never taken Ozempic.
Nearly all of the reports in FAERS are filed by the manufacturers, Novo Nordisk or Eli Lilly, who are required to report adverse events to the FDA. These are often reported to them by patients or healthcare workers.
The FDA says it does not comment on third-party reviews of FAERS, such as those conducted by the media.
An agency spokeswoman added: “Protecting patients from unsafe, ineffective and poor-quality medications is paramount to the FDA’s mission to promote and protect consumer health.
‘The FDA maintains extensive postmarket surveillance and risk evaluation programs for approved products to identify problems that may not have been discovered during the product development process.
‘However, spontaneous reports of adverse events often lack the complete information needed to draw a reasonable conclusion about whether there is an association between a product and an adverse event.’
The agency added: ‘Duplicate reporting and greater awareness of an event with a particular product may increase the number of adverse events reported.’
Compared to the 100 deaths attributed to weight-loss drugs each year, 16,000 every 12 months are attributed to NSAIDs: nonsteroidal anti-inflammatory drugs used to treat pain and inflammation, such as ibuprofen and aspirin.
The FDA previously warned that Ozempic may in rare cases cause an intestinal blockage (ileus) because it slows the passage of food through the intestines.
This can cause them to rupture and spill their contents into the body, which if not treated promptly can lead to sepsis and multi-organ failure.
Many patients who use the drug are also obese, which puts them at greater risk for serious side effects from complications that the drug can cause.