Eli Lilly Files Lawsuits Against Clinics Selling Knockoff Mounjaro

of Food and Drug Administration (FDA) The company previously issued a warning in May about compound versions of drugs similar to Munjaro, including Ozempic and Wigovy.

At the time, the FDA warned that compounded products may contain slightly different active ingredients than brand-name drugs. Regulators say they have not gone through an evaluation process to ensure safety and effectiveness, making them potentially unsafe.

Eli Lilly says it has similar concerns about copy versions of Mounjaro.

according to Dr. Stephen BatashThe board-certified gastroenterologist and physician-in-chief of the Batash Endoscopic Weight Loss Center custom-makes combination versions of drugs, including semaglutide, to address needs that are not met by commercially available products. .

“In the context of Munjaro, this drug is approved for the treatment of type 2 diabetes,” he explained. Using a combined version of this drug is beneficial for patients who are allergic to certain components of the standard drug or who require different dosages. ”

A small portion of prescriptions are filled by compounding pharmacies that specialize in filling customized orders.

Compounding pharmacies must use pure pharmaceutical-grade ingredients and be prepared in an FDA-registered facility.

However, compounding pharmacies are not subject to the same set of regulations as FDA-approved drugs.

“It is important to note that the safety, quality, and efficacy of these combined versions have not been reviewed by the U.S. Food and Drug Administration or any regulatory agency worldwide,” Batash said, adding that “they do not expose users to health risks. There is a possibility.”

Dr. Naheed Ali, physician and author. Promotion of healthcaresaid there are several risks that combined drugs can pose.

First, Ali said, compounded drugs don’t go through the same rigorous quality controls and testing that over-the-counter drugs do.

“This lack of standardization can lead to variations in potency, purity, and overall effectiveness of the drug,” Ali said. “In the case of Munjaro, which can be prescribed for serious medical conditions, any discrepancies in dosage or formulation can have serious health implications.”

Ali further pointed out that the combined drugs have not undergone the same safety and efficacy evaluations.

“The FDA does not regulate combination drugs to the same extent, which can make it difficult to properly assess their safety profile,” he said. “Without robust clinical trials and long-term research, the potential side effects and interactions of formulated Munjaro may not be fully understood, potentially exposing patients to unexpected health risks.”

Finally, Ali pointed to the fact that the source and quality of raw materials can vary widely. “This variation can lead to contamination issues, exposure to allergens, or the use of substandard raw materials,” he explained.

Ali advises that people using the combined version of Munjaro should work closely with their doctor to monitor that it is working effectively and not having any negative effects on their health.

“Overall, while combination drugs can be valuable in certain situations, they also come with inherent risks that need to be carefully considered and managed,” he said.

As to whether a compounding pharmacy is violating the law by manufacturing its own version of a patent-protected drug. Dr. Jonathan KaplanThe doctor, a board-certified plastic surgeon at Pacific Heights Plastic Surgery, said the practice was “totally legal.”

“The FDA allows compounding pharmacies to manufacture copies of over-the-counter drugs if the name-brand drug is on FDA’s shortage list,” he noted.

Kaplan went on to say that pharmacies that manufacture combination versions of Munjaro with the active ingredient tirzepatide obtain the drug from FDA-approved manufacturers. CGMP (Current Good Manufacturing Practice). This program is overseen by the FDA and ensures that medicines meet defined quality standards.

“When physicians use FDA-approved compounding pharmacies, which also must be licensed by their state Board of Pharmacy, the risks of compounding versions are greater than the potential side effects seen with name-brand drugs. Nothing has changed,” Kaplan said.

Dr. Sue DecotisThe company, a triple-board certified weight loss specialist, agrees that it is legal to produce a compounded version of Mounjaro if you follow FDA guidelines. But she points out that Florida compounder Wells provided the drug to Medispath, which advertised the drug as Maunjaro, when it was actually generic tirzepatide.

“It’s like calling a tissue Kleenex,” Decotis says.

In addition, some pharmacies were selling the drug directly to patients, and the FDA immediately shut down those stores, DeCotis said.

“Compounds that do not follow strict guidelines or fail frequent testing will be shut down,” she explained.

Decotiis also noted that some of her patients had purchased tirzepatide and semaglutide (generic drugs from Ozempic and Wegovy) online but found they were ineffective.

However, Decotiis cautions that all combination drugs should not be placed in the same category.

“It is highly misleading for Lilly to say that they cannot guarantee the quality of compounded tirzepatide. Big Pharma does not regulate compounding pharmacies. That is up to the authorities.”

Eli Lilly, the maker of the diabetes drug Munjaro, is suing several companies that sell combination copies of its drug.

Although this practice is not illegal if FDA guidelines are followed, Eli Lilly believes that certain providers are not following guidelines.

They say this may not be safe for consumers because patients may receive a product that has not been proven safe and effective.

If you are using combination medications, it is best to consult your doctor to ensure that they are effective for you and are not harming your health.