Counterfeit Weight Loss Drug Warnings
- Novo Nordisk, a Danish multinational pharmaceutical company, has issued a warning about counterfeit weight loss drugs pretending to be the FDA-approved Ozempic, a prescription medication for adults with type 2 diabetes, and the dangers associated with them.
- Nova Nordisk CEO Lars Fruergaard Jorgensen said his company is working with authorities across the globe to take on fake versions of the company’s semaglutide (known under the brand names Ozempic, Rybelsu, Wegovy).
- According a report from anti-counterfeiting group The Partnership for Safe Medicines, counterfeit weight loss injection medicines, like Ozempic, has been found in the following 16 countries: Australia, Belgium, Ireland, Azerbaijan, Egypt, Iraq, Jordan, Lebanon, Nigeria, Turkey, Uzbekistan, Russia, U.S., Germany, Austria, and the U.K.
- Ozempic, the brand name of Novo Nordisk’s semaglutide, a highly popular drug also known under the brand names Rybelsu and Wegovy, is an FDA-approved prescription medication for adults with type 2 diabetes. The drug, which is administered as a weekly injection, assists the body by helping the pancreas make more insulin, ultimately lowering blood sugar levels. Although it has not been FDA-approved for weight loss, the drug has been prescribed by some doctors.
- If you’re considering taking a weight loss drug, talk with your care team about whether that’s a good option for you. And make sure you consider good diet and exercise practices as a part of your treatment plan.
The drugmaker’s CEO Lars Fruergaard Jorgensen told Reuters this month that his company was working with authorities in various countries to undertake counterfeit versions of Novo Nordisk’s semaglutide (known under the brand names Ozempic, Rybelsu, Wegovy).
Read MoreEarlier this month, Reuters obtained reports from the Freedom of Information Act (FOIA) requests revealing patients were harmed after taking fake version of Ozempic in Belgium, Iraq, Serbia and Switzerland in 2023.
Meanwhile, U.S. Food and Drug Administration Commissioner Dr. Robert Califf has also raised concerns about the amount of counterfeit weight loss drugs online.
“In the context of the total picture of illicit drugs being sold on the internet, it’s almost certainly bigger than, much bigger than what we see,” Dr. Califf previously told Reuters, referring to recent reports received by the FDA.
Noting how the dangers counterfeit drugs is not limited to weight loss drugs, he added, “I’m taking four generic drugs for my hypertension and elevated cholesterol… and if I got a drug that was half as potent as I thought it was, I could have a heart attack, never knowing that I didn’t get the treatment that I thought I was getting.
“”The cough syrup catastrophe [referring to contaminated Indian-made cough syrups linked to children deaths], which didn’t affect the U.S but killed a number of children in Asia (and Africa), really called attention to the problem.”
As for the reports, created by Novo Nordisk, to the FDA, they showed people had experienced hypoglycemia [dangerous drops in blood sugar] after taking a suspected or confirmed fake versions of the weight loss drug.
Meanwhile, another report filed with the FDA revealed a woman, 45, in Belgium, experienced a seizure and wound up in a diabetic coma following use of a suspected fake Ozempic for weight loss, Reuters explains.
In June 2023, Novo Nordisk released a company statement, revealing they were working with the US Food and Drug Administration (FDA) and informing the public that “a counterfeit Ozempic® (semaglutide injection) pen was found in the U.S.”
The statement read, “The product was reportedly purchased at a retail pharmacy and the company is actively investigating the report and collaborating with the FDA to identify the origin and distribution of the counterfeit pen. The counterfeit product appears to have contained another type of diabetes medication, insulin glargine injection, that works differently than Ozempic®, which reportedly led to an adverse reaction.
“Patients prescribed semaglutide injectable products, FDA-approved and marketed under the brand names Ozempic® and Wegovy®, should be vigilant in checking their medicine to ensure they are taking an authentic, Novo Nordisk produced version of the authorized drug and injection device. The safety or efficacy of counterfeit products cannot be assured and they should not be used. Potential risks of taking a counterfeit medicine include serious adverse events.”
“Medications purchased online or in-person from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Purchasing and administering counterfeit, illegal and unapproved medications from online or in-person unlicensed or foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment,” the statement concluded.
Additionally, Nova Nordick’s Jorgensen, also pointed out how compounded semaglutide in the U.S. also poses serious health risks for those taking it.
With regard to the raw materials, or active pharmaceutical ingredients (API), coming from unregulated facilities in other countries, Jorgensen told Reuters, “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product.”
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FDA On Illegally Marketed Semaglutide & Counterfeit Ozempic
The FDA has warned that it’s found illegally marketed semaglutide online and counterfeit Ozempic in the U.S.
“FDA vigilantly monitors the internet for fraudulent or unapproved products and has issued warning letters to stop the distribution of illegally marketed semaglutide. These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients,” the FDA states on its website.
It adds, “FDA is aware and is investigating reports of counterfeit Ozempic being marketed in the U.S. The agency investigates any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response, and remains vigilant in protecting the U.S. drug supply from these threats.
“While we understand certain drugs are in short supply and patients are having difficulty obtaining their medication, FDA urges patients to obtain prescription drugs only from state-licensed pharmacies that are located in the U.S., where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. FDA’s BeSafeRx campaign helps consumers learn about how to safely buy prescription medicines online. FDA recommends patients to talk to their doctor if they have questions about their medicines.”
New Experimental Weight Loss Drugs
Just last month Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company working to develop novel therapies for metabolic and endocrine disorders, announced a clinical trial has found weight loss success with a new drug. Obese or overweight people in the trial were found to lose about 14.7 percent of their body weight after taking it via injection once a week for 13 week.
Viking Therapeutics said in a news release, “Reductions in body weight were progressive through the course of the study, with no plateau observed for weight loss at 13 weeks.
“All doses of VK2735 also demonstrated statistically significant differences relative to placebo on the key secondary endpoint assessing the proportion of patients demonstrating at least 10% weight loss. Up to 88% of patients in VK2735 treatment groups achieved ≥10% weight loss, compared with 4% for placebo.”
Meanwhile, early results from another trial on an experimental weight loss pill has been found by Novo Nordisk to possibly be “twice as effective as its blockbuster Ozempic and Wegovy jabs,” according to a report from the Agence France-Presse.
“The drug amycretin caused people to lose 13 percent of their body weight over three months, according to the results of a phase one trial announced by the company,” the report adds. “Previous trials have found that Novo Nordisk’s Ozempic and Wegovy drugs lead to around six percent body weight loss over the same period. However experts emphasized that significantly more research was needed to establish the long-term effectiveness and safety of amycretin.”
Health Risks Associated With Ozempic
Although people have had success with weight loss thanks to Ozempic, it’s important to understand there are dangers associated with “chasing skinny.” Healthcare company Lexicomp recently revealed there are negative side effects of the medication, including an increased risk of cancer.
Lexicomp explains Ozempic as “an injectable prescription medicine for adults with type 2 diabetes mellitus that: along with diet and exercise may improve blood sugar (glucose),” noting it’s not the first choice of medicine for treating diabetes.
As for the most important information people should know before taking the drug, Lexicomp says Ozempic may cause serious side effects. Some of the possible side effects include:
- inflammation of your pancreas (pancreatitis)
- changes in vision
- low blood sugar, kidney problems
- kidney failure
- serious allergic reactions.
“The most common side effects of OZEMPIC may include nausea, vomiting, diarrhea, stomach (abdominal) pain and constipation. Talk to your healthcare provider about any side effect that bothers you or does not go away,” Lexicomp states.
“These are not all the possible side effects of OZEMPIC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.”
The Memorial Sloan Kettering Cancer Center also says, regarding Lexicomp’s warning, “This drug has been shown to cause thyroid cancer in some animals. It is not known if this happens in humans.
“If thyroid cancer happens, it may be deadly if not found and treated early. Call your doctor right away if you have a neck mass, trouble breathing, trouble swallowing, or have hoarseness that will not go away.
“Do not use this drug if you have a health problem called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or if you or a family member have had thyroid cancer.”
The side effects that call for immediate medical attention, in regard to all uses of the drug, the MSKCC lists as:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
- Severe dizziness or passing out.
- A fast heartbeat.
- Change in eyesight.
- Low blood sugar can happen. The chance may be raised when this drug is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
- Severe and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. Call your doctor right away if you have severe stomach pain, severe back pain, or severe upset stomach or throwing up.
For anyone using the drug for weight loss, they should speak with their doctor if they notice “new or worse behavior or mood changes like depression or thoughts of suicide.”
How Does Semaglutide Work?
Integral to blood sugar control, GLP-1 is a hormone released by the gut in response to food. It causes the pancreas to release insulin. A rising blood insulin level causes all the body tissues to start absorbing glucose (blood sugar) from the bloodstream, thereby lowering blood glucose levels. GLP-1 also prevents the release of glucagon, which is a hormone that raises blood sugar levels by stimulating liver cells to release glucose and helps people feel full for longer. These effects can also cause people to lose weight.
Modern studies on GLP-1 have shown that it has a role beyond glucose control. It modulates the immune system cells, including NK cells, in a way necessary for weight loss.
Semaglutide is a GLP-1 receptor agonist, meaning that it mimics the effects of GLP-1 in the body. Given as weekly subcutaneous injections It is normally prescribed to manage blood glucose levels in diabetic patients. It also leads to a significant amount of weight loss in these patients.
Semaglutide Communicates With The Immune System
In a recent study, researchers studied the interaction between semaglutide and NK cell function in 20 patients with obesity. They were started on semaglutide therapy, given weekly, for 6 months. NK cells were isolated from these patients before commencing therapy and after 6 months of therapy completion. Their number and their function were measured to see if it was influenced by semaglutide.
Patients had no significant change in NK cell numbers after receiving semaglutide for 6 months. NK cell function, however, was significantly improved by the drug. The researchers detected a measured increase in cytokines after semaglutide therapy. Cytokines are small molecules released by NK cells that are essential to their function. This includes enhancing their anti-cancer activity. Additionally, 9 out of 20 patients had a significant change in their body weight during the study period.
It should be noted that this was a relatively small study of 20 patients. It nonetheless highlights an important benefit of semaglutide that should be explored in larger future studies.
Since the patients in the study lost weight, it is fair to question whether it was the weight loss or semaglutide that improved the NK cell function.
The researchers anticipated this confusion and tested whether the observed weight loss was associated with changes in NF-associated cytokine production. They found no correlation between the two, thereby demonstrating that the improved NK cell function was indeed due to the medication use. They further cemented this association by exposing extracted NK cells to GLP-1 directly, which caused them to significantly increase their cytokine production.
Semaglutide Carries Side Effects
Semaglutide is an invaluable addition to the repertoire of drugs used to fight diabetes and obesity and strengthen the immune system, as demonstrated by the study. However, like all drugs, it carries side effects that must be considered by anyone contemplating treatment with semaglutide.
Side effects include:
- Nausea.
- Vomiting.
- Stomach Pain.
- Constipation or Diarrhea.
- Low blood sugar, which can cause dizziness, confusion, sweating, and headaches.
Most of these side effects can be managed with lifestyle modifications, such as eating more slowly and avoiding greasy and fried food.
Semaglutide can, occasionally, cause serious side effects, such as:
- Inflammation of the pancreas
- Gallbladder problems
- Kidney problems
- Allergic reactions
These side effects require prompt medical attention.
Although semaglutide has been approved for blood sugar control in people with type II diabetes, under the brand name Ozempic, and for weight loss under the brand name Wegovy, it has not been approved for use as an immune booster and cancer preventative. Thus, it should not be prescribed for that purpose. Those taking it to control their diabetes or weight, however, can expect the additional benefit of improving their immunity and lowering their cancer risk.
The current semaglutide landscape may change in the future as more and more studies discover its benefits beyond controlling diabetes and aiding in weight loss.
Weight and Cancer Risk
Being overweight or obese is clearly linked to an overall increased risk of cancer, according to the American Cancer Society. And in a 2022 study out of Brigham and Women’s Hospital, Boston, researchers found that childhood obesity may lead to an early cancer diagnosis.
In a previous interview with SurvivorNet, Dr. Andrea Tufano-Sugarman of NYU Langone Health talked about the importance of maintaining a healthy weight.
“While all cancers cannot be prevented, losing weight is a great way to reduce one’s risk,” she said.
Major Reduction in Cancer Risk by Following Old Standbys Diet and Exercise
Dr. Stephen Freedland of Cedars Sinai Medical Center also notes that obesity can affect a person’s prostate cancer risk and prognosis.
“Some of the best data we have is that obesity increases the risk of not just getting prostate cancer, but actually dying from prostate cancer,” Dr. Freeland previously told SurvivorNet.
“Obese men are 35 percent more likely to die from prostate cancer.”
The Link Between Obesity and Prostate Cancer
Being overweight or obese is clearly linked with an increased risk of many types of cancer including the following:
- Breast cancer (in women past menopause)
- Colon and rectal cancer
- Endometrial cancer (cancer of the lining of the uterus)
- Esophagus cancer
- Gallbladder cancer
- Kidney cancer
- Liver cancer
- Ovarian cancer
- Pancreas cancer
- Stomach cancer
- Thyroid cancer
- Multiple myeloma
- Meningioma (a tumor of the lining of the brain and spinal cord)
Being overweight or obese might also raise the risk of other cancers such as:
- Non-Hodgkin lymphoma
- Male breast cancer
- Cancers of the mouth, throat, and voice box
- Aggressive forms of prostate cancer
It’s also important to know that conditions caused or exasperated by obesity like diabetes and heart disease can pose problems for people who’ve already been diagnosed with cancer. They can lead to treatment complications, prevent people from receiving the recommended first-line therapies and even increase the risk of undergoing surgery. Overweight patients might not even have the option of surgery since removing the cancer could pose potential complications that could outweigh the benefits.
Dr. Sairah Ahmed, associate professor in the division of cancer medicine at the University of Texas MD Anderson Cancer Center, previously said focusing on diet and exercise in a healthy way can help a person with cancer feel like they have more control.
“Diet, exercise and stress control are extremely important when going through cancer therapy, as well as once you’re done treating your cancer and trying to get back to the rest of your life,” she said.
Dr. Ahmed wants to remind people that none of the gimmicky diets are helpful for cancer-fighting. She says the main goal should be to simply consume nutritious foods.
What to Know about Diet and Exercise if You Have Cancer
“I’m asked about keto diets, alkaline diets, no-sugar diets,” she said. “Often I will tell patients there is not any one diet that has a better potential to keep their cancer away. There’s no data that shows that any of those help to treat cancer any better.
“You want to have a moderate diet where you’re including lots of fruits and vegetables, but you’re still eating fat and protein, and you want to maintain physical exercise,” she said
Dr. Ken Miller says a healthy diet and regular workout routine are important
Dr. Ken Miller, the director of outpatient oncology at the University of Maryland Greenebaum Cancer Center, recommends these four things for cancer survivors to do to try and avoid another cancer diagnosis:
- Exercise at least two hours a week, walking counts
- Eat a low-fat diet
- Eat a colorful diet with lots of fruits and vegetables, doctors recommend two to three cups a day
- Maintain a healthy weight
Contributing: SurvivorNet
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