Skip to content
NOWCAST Pittsburgh's Action News 4 at 11pm Sunday
Watch on Demand
Advertisement

Ozempic, Wegovy maker start legal battle with certain med spas, clinics, compounding pharmacies

Ozempic, Wegovy maker start legal battle with certain med spas, clinics, compounding pharmacies
USED TO TREAT TYPE TWO DIABETES HAVE BEEN GETTING A LOT OF POPULARITY WITH PEOPLE GETTING THESE PRESCRIBED TO HELP THEM LOSE WEIGHT. YEAH, BUT SEVERAL PEOPLE WITH TYPE TWO DIABETES IN THE METRO ARE STRUGGLING TO FIND THE INJECTABLE FOR THEIR MEDICAL NEEDS. NEWSWATCH SEVEN’S ABBIE PETERSEN INVESTIGATES THE LOCAL IMPACT AND FINGER OF CHOICE. THIS IS JUST A SNAPSHOT INTO THE LIFE OF A TYPE TWO DIABETIC LIKE DOCTOR MICHAEL CRAWFORD. THEN YOU GIVE IT A LITTLE SQUEEZE. HE WAS DIAGNOSED FOUR YEARS AGO, BUT JUST RECENTLY FOUND MUJURU. IT’S BEEN A DRAMATIC DIFFERENCE FOR ME. LIKE CRAWFORD, ELDA HERNANDEZ SAYS THE DRUG OZEMPIC IS NECESSARY TO MAKING HER FEEL LIKE SHE CAN REALLY LIVE HER LIFE. IT’S REALLY, REALLY IMPORTANT. ON A SCALE OF 1 TO 100, 110, THE DRUG IS SO IMPORTANT TO THEM. BUT LATELY THEY’VE HAD A TOUGH TIME FINDING IT CALLED EIGHT, NINE, TEN DIFFERENT PHARMACIES AND NOBODY HAD IT. AND THEN SO YOU GO THROUGH ALL THAT PHONE WORK AND THEN 3 TO 5 DAYS LATER, YOU HAVE TO DO THAT AGAIN. CAN YOU FEEL ME A PRESCRIPTION? BECAUSE MY PHARMACY DIDN’T HAVE IT AND THEY AND THEN THE PHARMACIST CAME BACK AND SAID, NO, I NEED IT FOR MY OWN MY OWN PATIENTS. HERNANDEZ SAYS SHE EVEN WENT A MONTH AND A HALF BEFORE HER PHARMACY COULD GET THE PRESCRIPTION. AND IT’S A WEEKLY SHOT. THEY NEED TO STAY ON TOP OF IT. TAKES A COUPLE OF WEEKS FOR YOUR BODY TO ADJUST TO THE MEDICATION AND FOR IT TO WORK. AND WHEN HE MISSES THOSE INJECTIONS, CRAWFORD SAID HE CAN EXPERIENCE URINARY AND STOMACH ISSUES, INCLUDING SEVERE DIARRHEA. I’VE HAD TWO SHORTAGES 110 DAY AND 117 DAY, AND EACH TIME WHEN I COULDN’T GET IT FILLED, I IT’S A QUALITY OF LIFE ISSUE. YOU GO, YOU SUFFER THE CONSEQUENCES OF IT. THE MOST FRUSTRATING PART IS WHY THEY CAN’T GET IT. BUT THE PROBLEM IS, DOCTOR SEARS PRESCRIBING OFF LABEL AND FOR PEOPLE WHO ARE TAKING THAT DRUG AWAY FROM THE DIABETIC COMMUNITY WHO ARE TRYING TO MANAGE A DISEASE PROCESS OFF LABEL FOR WEIGHT LOSS, DOCTOR AVENE POPULAR WITH METHODIST HEALTH SYSTEM, IS BOTH CRAWFORD AND HERNANDEZ’S ENDOCRINOLOGIST. HE’S ON THE ENDOCRINE SOCIETY’S CLINICAL GUIDELINES COMMITTEE PATHOLOGY SAYS THEY’RE NOT THE ONLY ONES STRUGGLING TO FIND THE INJECTIONS. WE’VE BASICALLY JUST HAD TO WAIT TILL THE SUPPLY IS IMPROVED. THEIR DIABETES GETS WORSE. WE TRY TO PUT THEM ON OTHER DIABETES MEDICATIONS. IN THE MEANTIME, HE SAYS IN 2021, THERE WAS A SHORTAGE OF A SIMILAR DRUG. WE GO FDA APPROVED FOR WEIGHT LOSS THAT LED DOCTORS LOOKING FOR ALTERNATIVES TO PRESCRIBE LIKE OZEMPIC OR MUJURU. SO NOW YOU HAVE FDA SAYING, YOU KNOW, EVEN BEFORE SAID THESE DRUGS ARE NOT APPROVED FOR WEIGHT LOSS. AND THE DRUG COMPANIES SAYING THESE DRUGS ARE NOT APPROVED FOR WEIGHT LOSS, BUT PEOPLE WERE ABLE TO PRESCRIBE THEM. NOW THEY’RE EXTREMELY POPULAR, BUT YOU CAN SEE BOTH WEBSITES FOR OZEMPIC AND MONERO SPECIFICALLY POINT OUT IT’S NOT FDA APPROVED FOR WEIGHT LOSS, ONLY FOR DIABETES. AND THAT’S ALL PEOPLE LIKE CRAWFORD AND HERNANDEZ WANT IT FOR. IT HAS HELPED ME A LITTLE WITH THE WEIGHT. I’M NOT IN FOR THE WEIGHT. GUESS NOT. AT THIS AGE, I’M NOT IN FOR THE WEIGHT I’M IN BECAUSE THE WEIGHT I FEEL. DR. PATEL, LORI SAYS THE WEIGHT TYPICALLY COMES RIGHT BACK ONCE YOU STOP USING THE PRESCRIPTION WITH A SIMILAR EFFECT OF CRASH DIETING. AT THE END OF THE DAY, THESE DRUGS ARE NOT WITHOUT RISKS AND AND AND THEY’RE NOT. THEY ARE SOMETIMES LIFELONG MEDICATIONS FOR SOME PEOPLE TAKE THE SAFETY CAP OFF DR. PATEL LORI SAYS HE CAN SEE HOW THE DRUGS MIGHT CHANGE OBESITY TREATMENTS IN THE FUTURE. PUSH THE PLUNGER AND HOLD IT FOR ABOUT FIVE SECONDS. BUT FOR NOW, HE STRESSES, THEY’RE NOT FDA APPROVED FOR WEIGHT LOSS. I THINK SIMILAR DRUGS WILL SPAWN COMPETITIONS. YOU HAVE SIMILAR DRUGS THAT WILL COME OUT. WE’RE GOING TO HAVE MUCH BETTER TREATMENTS FOR OBESITY BECAUSE OF THESE MEDICATION BANS. ALL THREE WOULD BE OKAY WITH PEOPLE USING THE DRUGS JUST FOR WEIGHT LOSS. IF THERE WAS ENOUGH OF A SUPPLY FOR RIGHT NOW, THOUGH, EVENTUALLY THE MANUFACTURER HOPEFULLY WILL CATCH UP IN TERMS OF DEMAND. BUT ON THE SHORT TERM, THEY REALLY SHOULDN’T BE USING IT OFF LABEL FOR WEIGHT LOSS. WE REACHED OUT TO THE MAKERS OF BOTH DRUGS A SPOKESPERSON FOR NOVO NORDISK, THE MAKER OF OZEMPIC, SAYS, QUOTE, ALL DOSES OF OZEMPIC ARE NOW AVAILABLE TO RETAIL PHARMACIES NATIONWIDE FOR APPROPRIATE PATIENTS WITH TYPE TWO DIABETES. HOWEVER, PHARMACIES MAY EXPERIENCE NORMAL DELAYS GIVEN THE TIME REQUIRED TO ORDER THE PRODUCT FROM THEIR LOCAL DISTRIBUTION CENTER AND GEOGRAPHICAL VARIABILITIES. WE’RE STILL WAITING TO HEAR BACK FROM ELI LILLY, THE MAKER OF
Advertisement
Ozempic, Wegovy maker start legal battle with certain med spas, clinics, compounding pharmacies
Pharmaceutical firm Novo Nordisk says it has begun legal proceedings against some U.S. medical spas, weight loss or wellness clinics and compounding pharmacies "to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide," the active ingredient in its diabetes and weight-loss medications Ozempic, Wegovy and Rybelsus."These unlawful marketing and sales practices … have created a high risk of consumer confusion and deception as well as potential safety concerns," Novo Nordisk said in a news release Tuesday. It did not offer any further details on the targeted companies or their practices.Video above: Some with diabetes struggle to find diabetes drugsThe U.S. Food and Drug Administration issued a warning last month about some compounded versions of semaglutide.Compounding "is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient," the agency said. "Compounding includes the combining of two or more drugs."Semaglutide, a type of drug called a GLP-1 agonist, is FDA-approved as Ozempic and Rybelsus to treat type 2 diabetes and as Wegovy to treat overweight and obesity.The FDA said that it has received reports of adverse events in people who used compounded semaglutide and that patients "should not use a compounded drug if an approved drug is available."Ozempic and Wegovy have been on the FDA's Drug Shortages list since last year."When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act," the FDA said, but the agency doesn't review these compounded versions for safety, effectiveness or quality.Video below: Doctor talks about whether injecting Ozempic, Wegovy, Mounjaro to lose weight is safeSome compounders may also be using salt forms of the medication, such as semaglutide sodium and semaglutide acetate, which have different active ingredients from those in the approved drugs. "The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements. … Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective."Novo Nordisk said in its release that people who have a prescription for semaglutide "should be vigilant in checking their medicine to ensure they are taking an authentic" version. Its new website semaglutide.com offers more information on how to distinguish FDA-approved products from "counterfeit" ones.On an earnings call earlier Tuesday, Novo Nordisk said it's been ramping up production capacity of Wegovy, as it's had trouble keeping up with demand, last month limiting doses for new patients in the US to be able to meet the needs of people already taking the medicine.Video below: Learn more about the popular medications and other research related to the drugsThe company also plans to study whether it's possible for patients to maintain their weight loss after stopping the medication but expects it to be a chronic therapy for the foreseeable future."Based on the knowledge we have today, we're talking about a chronic treatment in order to maintain weight loss," Dr. Martin Holst Lange, executive vice president of development at Novo Nordisk, said in a briefing Tuesday. He noted that the company has shown that patients can maintain weight loss of about 15% over two years while staying on Wegovy but that those who stop the drug regain weight.CNN's Meg Tirrell contributed to this report.

Pharmaceutical firm Novo Nordisk says it has begun legal proceedings against some U.S. medical spas, weight loss or wellness clinics and compounding pharmacies "to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide," the active ingredient in its diabetes and weight-loss medications Ozempic, Wegovy and Rybelsus.

"These unlawful marketing and sales practices … have created a high risk of consumer confusion and deception as well as potential safety concerns," Novo Nordisk said in a news release Tuesday. It did not offer any further details on the targeted companies or their practices.

Advertisement

Video above: Some with diabetes struggle to find diabetes drugs

The U.S. Food and Drug Administration issued a warning last month about some compounded versions of semaglutide.

Compounding "is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient," the agency said. "Compounding includes the combining of two or more drugs."

Semaglutide, a type of drug called a GLP-1 agonist, is FDA-approved as Ozempic and Rybelsus to treat type 2 diabetes and as Wegovy to treat overweight and obesity.

The FDA said that it has received reports of adverse events in people who used compounded semaglutide and that patients "should not use a compounded drug if an approved drug is available."

Ozempic and Wegovy have been on the FDA's Drug Shortages list since last year.

"When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act," the FDA said, but the agency doesn't review these compounded versions for safety, effectiveness or quality.

Video below: Doctor talks about whether injecting Ozempic, Wegovy, Mounjaro to lose weight is safe

Some compounders may also be using salt forms of the medication, such as semaglutide sodium and semaglutide acetate, which have different active ingredients from those in the approved drugs. "The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements. … Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective."

Novo Nordisk said in its release that people who have a prescription for semaglutide "should be vigilant in checking their medicine to ensure they are taking an authentic" version. Its new website semaglutide.com offers more information on how to distinguish FDA-approved products from "counterfeit" ones.

On an earnings call earlier Tuesday, Novo Nordisk said it's been ramping up production capacity of Wegovy, as it's had trouble keeping up with demand, last month limiting doses for new patients in the US to be able to meet the needs of people already taking the medicine.

Video below: Learn more about the popular medications and other research related to the drugs

The company also plans to study whether it's possible for patients to maintain their weight loss after stopping the medication but expects it to be a chronic therapy for the foreseeable future.

"Based on the knowledge we have today, we're talking about a chronic treatment in order to maintain weight loss," Dr. Martin Holst Lange, executive vice president of development at Novo Nordisk, said in a briefing Tuesday. He noted that the company has shown that patients can maintain weight loss of about 15% over two years while staying on Wegovy but that those who stop the drug regain weight.

CNN's Meg Tirrell contributed to this report.