The World Health Organization (WHO) recently reported on three counterfeit batches of Ozempic that were discovered in late 2023 in Brazil, the United Kingdom, and the United States, with an unknown number of unreported cases. www.medscape.com/viewarticle/who-warns-against-counterfeit-ozempic-europe-and-united-2024a1000caq?
Novo Nordisk, the manufacturer, has confirmed that the batches in question are not original products. The pens may be ineffective or contain harmful ingredients. Toxicology results are currently unknown. Such counterfeit products easily enter additional markets through drug importers or re-importers.
Semaglutide is approved for the treatment of type 2 diabetes (Ozempic) or obesity (Wegovy), and Ozempic is used off-label for obesity. Given the market situation, it is not surprising that such products have become a target for counterfeiters.
Therefore, in the second quarter of 2024, the introductory dosage of Ozempic 0.25 mg will not be delivered, and Ozempic 0.5 mg will be delivered with restrictions. In other words, the product cannot be initiated in new patients. To reduce side effects, an initial subcutaneous dose of 0.5 mg is administered weekly and eventually increased to 1 mg weekly.
Yukiko Nakatani, WHO assistant director general for access to medicines and health products, advises physicians and pharmacists to be particularly vigilant with these products. The WHO has identified the following characteristics of counterfeit packages:
- The batch number LP6F832 does not exist.
- The combination of batch number NAR0074 with serial number 430834149057 does not match manufacturing records.
- The batch number MP5E511 is correct, but the product is counterfeit.
Pharmacists in all countries should pay attention to the following criteria when dispensing medication:
- The WHO advises against dispensing products labelled with suspicious batch numbers listed online.
- Counterfeit Ozempic pens, unlike the originals, may have a scale protruding from the pen when the user adjusts the dose.
- The label may not adhere well or at all to the pen.
- Spelling errors may be present on the front of the box.
In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for secure pharmacotherapy. “In addition to the known counterfeit of the drug Ozempic 1 mg (product code: 04150153985573, serial number: 1946483405690, and batch: MP5E511), no further packets with the counterfeit serial number or counterfeits with other serial numbers have been identified,” a statement reads.
In addition, in Germany, the securPharm system is available as another effective tool to detect counterfeit drugs. It was developed in accordance with the European Union (EU) Falsified Medicines Directive (2011/62/EU).
Each drug package receives a unique serial number, product code, batch number, and expiration date in the form of a Data Matrix code on the packaging before delivery from the factory. Manufacturers upload the serial numbers and other product information to a central database managed by securPharm. Throughout the supply chain (e.g., at wholesalers or pharmacies), employees scan the package and verify the code. If the serial number has already been used or does not exist in the database, the software issues an alert, and the medication cannot be dispensed.
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Cases of H5N1 avian influenza continue to rise in cattle in the United States. Countries are preparing for the possibility that the virus could spark a pandemic in people by ramping up surveillance, as well as purchasing vaccines or developing new ones. The Coalition for Epidemic Preparedness Innovations (CEPI) is working to ensure that the response is equitable worldwide. Their approach “for the moment is one of ‘calm urgency’” — “like putting our shoes on in case we need to start running”, says Nicole Lurie, who heads preparedness and response at CEPI.
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In January 2020, a man who would become known as the first documented Covid-19 patient in the United States arrived at an urgent care clinic.
Two of his symptoms, a cough and a fever, were among those that would become known as the telltale symptoms of Covid. But the patient had also experienced two days of nausea and vomiting. www.nytimes.com/2024/07/05/well/covid-symptoms-stomach-pain-diarrhea.html?
Many of us associate Covid with respiratory issues. But some people who get sick with the virus never experience a sore throat, coughing or body aches, said Dr Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco. Certain people end up feeling more like they have food poisoning than anything else.
That’s because coronavirus is “like throwing a bomb in your body,” said Dr Ken Cadwell, a professor of medicine at the University of Pennsylvania who studies how Covid affects the gut. “You’re going to feel that in multiple different organs, not just the lungs.”
With Covid cases climbing, and the so-called “FLiRT” variants fuelling yet another summer spread, here’s how to spot, and address, the lesser-known gastrointestinal symptoms.
In some people, gastrointestinal symptoms hit during the first few days of an infection, before they develop a fever and cough. But many people who only experience stomach symptoms “never think of it as Covid,” Dr Chin-Hong said.
Diarrhoea is a common Covid-related gastrointestinal symptom, Dr Chin-Hong said. People can also lose their appetite, and experience nausea, abdominal pain and vomiting.
Covid doesn’t look the same every time you get infected, said Dr Davey Smith, an infectious disease specialist at the University of California, San Diego. You might have cold and flu symptoms during one bout of the virus, and gastrointestinal symptoms the next time. Paxlovid, an antiviral medication that reduces the risk of severe disease, can also cause diarrhoea.
Hydration is important for anyone with Covid, but drinking enough fluids is critical if you experience diarrhoea or vomiting. If you’re struggling to hold food down, stick to bland foods like toast and bananas, said Dr Adrienna Jirik, a gastroenterologist at Cleveland Clinic.
Those who share a bathroom can take steps to avoid contaminating the area with the viral particles in your waste, like opening a window to improve ventilation.
The most common variants currently circulating appear to cause the same symptoms we’ve seen in other recent strains of the virus.
In addition to digestive discomfort, people commonly develop a sore throat, congestion or a runny nose, head and muscle aches, fever or chills, a cough and fatigue. In severe cases, they can struggle to breathe. While some people who get sick lose their sense of taste or smell, that symptom is far less common now than it was earlier in the pandemic.
Any of these symptoms can hit days after spending time with someone who has the virus. If you know you’ve been exposed, it’s important to keep an eye out for all the symptoms, including gastrointestinal ones, Dr Chin-Hong said.
“If everybody in your house has Covid and you have diarrhoea, then you have to put two and two together,” he said.
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Up to 60% of men with erectile dysfunction who were not candidates for phosphodiesterase 5 (PDE5) inhibitors achieved erections in less than 10 minutes after a single application of a first-on-the-market nonprescription gel to the glans, a new study found. www.medscape.com/viewarticle/otc-solution-erectile-dysfunction-2024a10008ms?ecd=mkm_ret_240714_mscpmrk-OUS_BO_etid6664060&uac=398271FG&impID=6664060
Dr Wayne Hellstrom, chief of andrology at Tulane School of Medicine in New Orleans, who presented the study of MED3000 [Eroxon] on May 5 at the 2024 annual meeting of the American Urological Association in San Antonio, Texas, said that the gel is considered to be a device by the US Food and Drug Administration. The agency approved the product in June 2023.
A spokesman for Futura, which makes MED3000, said that the gel will be on the market 2025. No price for the United States has been announced, but a four-pack of single-use tubes sells for the equivalent of roughly $31 in the United Kingdom.
Hellstrom, a former advisor to Futura, said he expects MED3000 will be “a potential first-line therapy in addition to PDE5 inhibitors,” which are vasodilating drugs that stimulate the corpora cavernosa of the penis, facilitating erection with sexual stimulation.
He noted that PDE5s are contraindicated for many men; are not tolerated in others; are not completely effective; or work too slowly, taking 1-2 hours to work. As a result, up to 50% of patients cease using a PDE5 inhibitor within 1 year, he said.
Futura said the gel contains a combination of volatile solvents which, when applied to the head of the penis, evaporate rapidly, stimulating nerve endings through an initial cooling effect followed by a warming sensation. This reaction releases nitric oxide, relaxing the smooth muscle tissue inside the penis and increasing blood flow that is needed to obtain an erection.
Hellstrom noted that MED3000 is non-invasive and causes no side effects and is slightly more effective if applied by a partner.
The new findings come from two studies of 250 men with erectile dysfunction (FM57) who used MED3000 over 12 weeks and a randomly assigned arm (FM71) with two groups of 48 men who used either MED3000 or 5 mg of tadalafil over 24 weeks.
Erections were achieved in less than 10 minutes in 60.1% of men in the FM57 group and 44.9% of those in the FM71 group.
Overall, less than 2% of the men who used MED3000 and 4% of those who took tadalafil reported adverse effects. These events included headaches in 3% of the combined MED3000 group and 19.1% of the tadalafil group. Roughly 1% of men who used MED3000 reported penile burning sensation compared with none in the group taking tadalafil.
Dr Kevin McVary, a professor of urology at Stritch School of Medicine of Loyola University, outside of Chicago, and director of the Centre for Male Health, criticized the study design and added that he did not believe MED3000 had been proven beneficial.
“Are they expecting the Cialis 5 mg to work within 10 minutes? Because it doesn’t,” McVary said. “It doesn’t get absorbed into the bloodstream for about 2.5 hours.”
McVary said that men with erectile dysfunction will probably do anything to avoid seeing a physician about the condition, which could make MED3000 highly marketable.
However, he said, examinations would be important to detect unrecognized underlying cardiac disease, especially in younger men. “ED can function as the classic canary in a coal mine where it tells you who’s at risk for unexpected early death,” he said.
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Lalita Panicker is Consulting Editor, Views and Editor, Insight, Hindustan Times, New Delhi
