The US Food and Drug Administration (FDA) recently warned two online suppliers to stop manufacturing unapproved versions of semaglutide (marketed as Ozempic for type 2 diabetes). 2; Wegovy for obesity) and tirzepatide (Mounjaro). With ongoing shortages of these two popular drugs, compounded versions have become popular.
According to the FDA, compounding pharmacies are allowed to prepare “substantially a duplicate” of an approved drug, when a drug is listed as in short supply. Wegovy, Ozempic and Mounjaro are all listed on the FDA’s drug shortage database.
However, compounded drugs are not approved by the FDA, and the agency does not verify the safety or effectiveness of compounded drugs. A 2020 review found 63 errors compounded in 2,155 reports related to contamination or concentrations. While drug compounding plays an important role, it “has the potential to harm patients without appropriate safeguards,” the authors wrote.
In June, the FDA issued a warning about new anti-obesity drugs, saying it had received reports of side effects after people self-administered semaglutide from a compounding pharmacy. The warning also states that compounding pharmacies may sell salt forms of the active ingredient, including semaglutide sodium and semaglutide acetate, although FDA is not aware of any basis for compounding a drug using the semaglutide salt that meets federal requirements.
So far in 2023, the FDA has received reports of 4,130 adverse events associated with semaglutide. The side effect reporting system did not specify where the drug was purchased in these cases.
Synthetic drugs are not necessarily equivalent
This creates significant concern for clinicians in counseling patients who wish to fill a prescription for these anti-obesity drugs.
Chika Anekwe, MD, MPH, a bariatric medicine physician at the Massachusetts General Hospital Weight Center and an instructor at Harvard Medical School, Boston, Massachusetts, advises patients not to take the synthetic drug semaglutide. We don’t know their purity, safety or effectiveness,” Anekwe said.
David Margraf, PhD, PharmD, a pharmaceutical research scientist at the University of Minnesota’s Center for Infectious Disease Research and Policy, Minneapolis, believes that mixed formulations of semaglutide are a “very risky thing to do.” “.
“The problem is [GLP-1] “The available drugs are not all the same. Unless it’s been in clinical trials, you don’t know whether it’s bioequivalent to the drug it’s trying to mimic,” Margraf said.
“That can affect how the drugs work, how they are absorbed,” Margraf said.
There may also be a risk of unintended side effects or different mechanisms of action over the long term with salt formulations, he added.
“It’s injected to disrupt a lot of the natural defense mechanisms that you have at your disposal. [a drug] orally,” Margraf said. “Compounding pharmacies may only have access to the salt form of the drug and not the FDA-approved form.”
When drugs are taken orally, Margraf explains, the body’s main natural defense mechanism is stomach acid, which is filtered by the liver and kidneys before the drug molecules enter the bloodstream. With subcutaneous injection, “any impurities can disrupt that process if the mixed drug is not sterile.”
A Google search for Ozempic or Wegovy will uncover a thriving online forum for sellers purporting to stock the sought-after drugs. Some are licensed compounding pharmacies, marketing copycat versions of the brand-name drug semaglutide to patients with prescriptions.
“This is truly is the Wild West.”
“The bottom line for me as a clinician who is trying to provide the most effective and safest treatments to my patients is that we recommend the treatment has been rigorously studied in randomized controlled trials.” “Combined drugs have not been studied in large randomized controlled trials.”
Novo Nordisk, the company that makes Wegovy and Ozempic, has filed a lawsuit against compounding pharmacies, as well as medical spas, wellness and weight loss clinics, claiming false advertising, trademark infringement and illegal sales. One of the lawsuits against a compounding pharmacy in Florida was recently dismissed, but the decision allows the company to file an amended lawsuit.
According to a press release from Novo Nordisk: “Compounded products do not have the same guarantees of safety, quality and effectiveness as our FDA-approved drugs and may put patients at risk about health”.
Similarly, Eli Lilly, the pharmaceutical company that makes tirzepatide, announced legal action against compounded formulations calling itself Mounjaro.
Scott Brunner, executive director of the Pharmaceutical Compounding Alliance, said: “There are good reasons why pharmaceutical compounding exists, and it’s all about making sure patients get the medicine their prescriber intended. the form says they need it when they need it.” “It’s probably a capsule. Your grandmother can’t swallow capsules. The pharmacist can prepare a syrup.”
Clinicians and patients can search for state-licensed online pharmacies through the FDA’s BeSafeRx tool. The FDA also published guidelines for detecting unsafe online pharmacies.
In a statement to Medscape Medical NewsThe FDA says, “purchasing drugs online from unregulated, unlicensed sources may expose patients to potentially unsafe products that have not undergone the appropriate review or approval process or does not meet quality standards.”
Healthcare professionals Use with caution
While shortages of semaglutide are expected to continue, Lemrey “Al” Carter, chief executive officer of the National Association of Boards of Pharmacy, recommends that doctors advise patients to purchase the drug from a pharmacy. licensed compounding medicine.
Carter believes that licensed compounding pharmacies may be the only way to address the semaglutide shortage. However, he also advises doctors to remind patients to watch for warning signs, such as online sites offering drugs without a prescription.
“If you’re trying to buy a drug without a prescription, that’s a red flag, and if you can get it, that’s a red flag,” Carter said. “I wouldn’t trust that medicine.”
Others, like Ted Kyle, RPh, former executive at GlaxoSmithKline and founder of ConscienHealth, an organization that works to promote policy and evidence-based approaches to obesity, kidney complete remission with mixed semaglutide.
“What concerns me is the lack of transparency and authenticity about what the hell are you doing here?” Kyle said. “Where do you get this chemical from? And what is the chemical you’re forcing people to inject into themselves?”
“I understand why patients consider using combination medications, but I caution against doing that because we don’t know the safety,” Saunders said.
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