Ten Americans die and 100 are hospitalized after taking drugs like Ozempic
Ten people have died and 100 have been hospitalized after taking pharmacy-made copies of Ozempic, its manufacturer has revealed.
These combination weight loss drugs, which are often cheaper, were sold by med spas and pharmacies during a national shortage of the popular drug two years ago.
Ozempic’s maker Novo Nordisk says these brands of its brand-name drugs are made with little control or warning that pose a risk of getting sick after using them.
Few details about the patients have been revealed, including their locations, ages or negative reactions.
But the FDA says reactions to the compounded versions are often linked to drug overdoses or people accidentally administering the wrong dose, which can lead to people being hospitalized for complications including nausea, vomiting, diarrhea, abdominal pain and constipation.
Experts have also warned that an overdose can leave a person at risk of seizures and even fainting – because the drug can cause very low blood sugar.
Novo disclosed these cases after asking the FDA to ban variants of its Ozempic and Wegovy drugs last month. It says they are too complicated to be made by pharmacies.
Weight loss pills, which use a combination of drugs, have been in short supply for more than two years in the US after a Hollywood operation used them for their promise to help people lose weight. weight without the weekly injection.
Compounded versions of Ozempic, made by pharmacies, are associated with death
The FDA still has to make a final decision on whether to ban the combination version of semaglutide, the active ingredient in Ozempic and Wegovy.
US law allows pharmacies to make their own, or compound, brands of known drugs when they are out of stock in order to fill prescriptions.
Supporters say this is necessary to ensure people continue to have access to potentially life-saving medicines and to follow the guidelines.
But, arguing with Ozempic practice, The CEO of Novo Nordisk, Lars Fruergaard Jorgensen, said it is strange that people in the US are allowed to inject themselves with a product that is not regulated, approved or tested.
‘It hits me’, he said in an interview with Reuters, before adding: ‘I think this is something that will change over time’.
Copycat versions were often sold online and through so-called ‘health spas’, rather than through an organized supply chain, Novo Nordisk said.
It is also investigating a number of compounding products that it says have multiple safety concerns, although these were not fully described.
Novo Nordisk’s tally is lower than the FDA’s, and the agency said it had received 346 reports of adverse events related to the compound semaglutide by the end of August this year. It does not give a death toll.
It is also lower than the number of deaths related to semaglutide, the drug used in Wegovy and Ozempic, reported in the FDA’s adverse event reporting system (FAERS) – which was 94 at the beginning of September this year.
The system only suggests a connection, and does not provide definitive proof that the injuries were caused by the drug.
Trish Webster, 56, from Australia, died after taking Ozempic to lose weight for her daughter’s wedding. She is pictured above with her husband Roy
There have been 68 deaths linked to tirzepatide, a drug used to reduce body weight, Mounjaro and Zepbound.
Novo Nordisk has already ramped up production to meet US demand, and Wegovy and Ozempic are both now available nationwide.
But the drug remains on the FDA’s shortage list, which allows pharmacies to continue making compounded versions.
Novo Nordisk chief financial officer Karsten Munk Knudsen said: “This is an ongoing discussion with the FDA.
‘I don’t want to think tody if we are completely out of the deficit list, but this is the first step and we are hopeful that we will go down in the future.’
About five million Americans will be prescribed semaglutide by 2023, according to Penn Medicine, four out of ten using it for weight loss.
One month of Ozempic costs $935.77 a month out-of-pocket, while a month’s supply of Wegovy costs $2,000.
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