exclusive
Apparently there are counterfeits of the popular weight loss drug Ozempic in circulation. Several people have already had to be treated in intensive care units. The trail leads to research by NDR, WDR and SZ to two dubious pharmaceutical companies in Austria.
The fourth Ozempic pack that an Austrian woman received from her Salzburg plastic surgeon was apparently counterfeit. The 31-year-old had to be admitted to hospital at the end of September with life-threatening side effects. She is the first of several people affected who had to be treated in the intensive care unit because they had allegedly received counterfeit Ozempic.
The drug is actually only approved for diabetics. But it also works as a weight loss injection. The active ingredient semaglutide is the same as in the official weight loss syringe Wegovy. Both are produced by the manufacturer Novo Nordisk. But while he charges 42 euros for the weight loss injection, the same amount of the active ingredient in the diabetic syringe only costs 18 euros. There has therefore been enormous demand for Ozempic worldwide, with the result that diabetics are often no longer able to get their medication – and dubious traders have apparently specialized in offering counterfeits of the preparation.
Cramps and hypoglycemia
Those affected by the counterfeit weight loss injections in Austria suffered from seizures and hypoglycemia, which the Austrian Federal Office for Safety in Health Care (BASG) interpreted as an indication that the injections contained insulin instead of Ozempic. In non-diabetics, insulin injections can lead to a life-threatening drop in blood sugar. The Austrian Federal Criminal Police Office therefore spoke of “health risks that could have led to death without immediate medical treatment.” The Steyr public prosecutor’s office is now investigating.
According to research by NDR, WDR and “Süddeutscher Zeitung”, the investigators from Steyr have a company from Upper Austria in their sights in the case of the Salzburg cosmetic surgeon. According to their website, this company primarily deals in medical devices. One of the two owners is also a cosmetic surgeon from Vienna. He left a written question unanswered. If you call the phone number listed on the website, an Austrian answers who says he doesn’t belong to the company at all, but only occasionally “brokers” something for them.
Suspicion of criminal activity
According to the Austrian supervisory authority BASG, a suspicion seems to be growing: the shortage of the drug is “apparently being exploited by criminal organizations to bring counterfeits of Ozempic onto the market.” The non-profit organization Partnership for Safe Medicines also believes it is unlikely that errors, omissions or tragic mix-ups are the cause of the incorrectly filled syringes. “It is almost certainly a criminal act,” says its director Shabbir Safdar. “The quality controls in the pharmaceutical industry are too strict to assume such a manufacturing error.”
In a similar case that recently became known in Germany, the trail of the syringe also leads to Austria. The Lörrach-based wholesale company Pharma Medtec bought Ozempic packs from a pharmaceutical company in Austria, which turned out to be suspected counterfeits. The Lörrachers sold the syringes to Great Britain, where they were noticed by a pharmaceutical wholesaler as an obvious counterfeit.
In conversation with NDR, WDR and “Süddeutscher Zeitung”, the managing director of Pharma Medtec explained that he himself had alerted the German regulatory authority, the Federal Office for Drugs and Medical Devices (BfArM), to the suspected counterfeits on September 27th. The BfArM confirms this statement upon request.
A few days after the report, the regional council inspected the Lörrach company. The local public prosecutor’s office is now investigating violations of the Medicines Act. With reference to the ongoing proceedings, the managing director of Pharma Medtec does not want to comment on this.
Company named in warning letter
The Lörrachers had purchased the goods according to information from NDR, WDR and SZ from the Austrian pharmaceutical company AZ Naturemed, based in Styria. The name of the pharmaceutical company also appears in warning letters from the BfARM to regional councils and wholesalers.
AZ Naturemed is a family business founded in 2018. Three of the four founders are doctors or psychotherapists. The company produces and sells cannabis products, homeopathic remedies and lots of esoteric products such as “Druid plants”, “light mushrooms” or “TAO essences”. There is also an “aura spray” to “support shamanic work” in order to “invite lost parts of the soul back home”.
Another branch of the company, Naturemed Pharma GmbH, trades in medicines and vaccines. On its website, the company announces, among other things: “We are a partner for the distribution of Russian vaccines.” Questions from NDR, WDR and SZ, the company left unanswered whether they manufactured the allegedly counterfeit Ozempic syringes themselves or from which source they obtained them.
Largecommercial approval withdrawn
According to its own information, the BfArM informed the Austrian authorities about the case on the morning of September 28th. When asked, the Federal Criminal Police Office there said: “At the moment, the investigations in Austria are solely the responsibility of the police. All relevant information is first collected” and only later “the locally responsible public prosecutor’s office will be involved.”
However, on October 9th, the Austrian Federal Office for Safety in Health Care (BASG) revoked AZ Naturemed’s wholesale license. The BASG has not yet announced this to the public, but a corresponding document can be found in the EU database EudraGMDP, where violations are made known.
Manufacturer does not answer questions
AZ Naturemed’s approval was revoked because it illegally purchased medicines from outside the EU, because it “does not maintain an effective quality assurance system” and because it “does not adhere to the guidelines on good sales practice for medicines”. However, for reasons of “official confidentiality”, the Austrian BASG does not want to disclose whether the withdrawal of the wholesale license at AZ Naturemed is related to the counterfeit slimming syringes.
According to the Austrian Federal Criminal Police Office, there is currently no indication that AZ Naturemed is also connected to those cases in which patients in Austria are in the clinic because of counterfeit Ozempic syringes. It is not yet clear whether insulin was also contained in the syringes supplied by AZ Naturemed to the Lörrach company. According to the BfArM, the analyzes have not yet been completed after four weeks.
The only manufacturer of Ozempic is Novo Nordisk. The Danish company did not answer specific questions about the case, such as how many counterfeit packages were found to the pharmaceutical giant’s knowledge and whether criminal charges were filed.