FDA alerts health care providers, compounders of dosing errors (2024)

What health care providers, compounders and patients should know

FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug.

FDA encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide.

Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports. Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors.

FDA encourages health care providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe.

Additionally, health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available. If uncertain, health care providers should contact the compounder about calculating the correct dose of medication to prescribe or administer.

Background

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. There are currently three FDA-approved semaglutide products:

  • WEGOVY injection is available as single-dose pre-filled pens that deliver a preset dose for once weekly dosing.
  • OZEMPIC injection is available as multiple-dose pre-filled pens for single-patient use, designed for once-weekly dosing.
  • RYBELSUS tablet is available as oral tablets for daily dosing.

The prescribing information for FDA-approved semaglutide injection contains information about overdoses that have been reported with other GLP-1 receptor agonists. Adverse effects include severe nausea, severe vomiting and severe hypoglycemia (low blood sugar levels). A prolonged period of observation and treatment for overdose symptoms may be necessary due to the long half-life of semaglutide of about one week.

FDA is aware of compounded semaglutide products that are being marketed for weight loss.

Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness. Compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug.

Compounded products containing semaglutide

There are various ways that compounded semaglutide products may differ from approved products[1] [2] that may contribute to potential medication errors. For example, FDA is aware that compounders offer semaglutide injectable products in various containers and packaging, including multiple-dose vials and prefilled syringes. Product concentrations also may vary depending on the compounder, and a single compounder may offer multiple concentrations of compounded semaglutide products.

Additionally, the instructions that accompany the compounded drug, if provided, may instruct users to administer semaglutide injections in “units” (the volume of which may vary depending on the concentration), rather than milligrams or milliliters. FDA is aware of some instances in which patients have been given syringes that are significantly larger than the prescribed volume of semaglutide (see example in Figure 1). These factors may cause confusion for health care providers when prescribing or dispensing and for patients who are measuring and self-administering these compounded products.

Adverse event summary

FDA has received reports of dosing errors involving compounded semaglutide injectable products dispensed in multiple-dose vials. Some patients sought medical attention or required hospitalization. Adverse events included gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.

Errors related to incorrect measurement of intended compounded semaglutide dose

The majority of the reports described patients mistakenly drawing up more than the prescribed dose from a multiple-dose vial during self-administration. In these instances, patients administered five to 20 times more than the intended dose of semaglutide. Most of the reports indicated that patients were unfamiliar with how to measure the intended dose using a syringe.

In several reports, patients were instructed to use a U-100 (1 milliliter) insulin syringe to draw small doses, such as a 5-unit (0.05 milliliter) dose, from a multiple-dose vial.

As depicted in the figure below, these patients were directed to administer 5 units from a vial. However, these patients mistakenly administered 50 units instead.

FDA alerts health care providers, compounders of dosing errors (1)

In one reported case, it was difficult for the patient to obtain clarity on dosing instructions from the telemedicine provider, who prescribed the compounded semaglutide, leading the patient to conduct an online search for medical advice and resulting in the patient taking five times the intended dose.

Errors related to compounded semaglutide dose miscalculations

FDA-approved injectable semaglutide products are dosed in milligrams, have standard concentrations and are currently only available in pre-filled pens. FDA is aware that compounders provide semaglutide in various concentrations.

Several reports describe health care providers incorrectly calculating the intended dose when converting from milligrams to units or milliliters, which resulted in patients administering five to 10 times more than the intended dose of semaglutide.

  • One provider intended to dose 0.25 milligrams (5 units), but prescribed 25 units instead, leading to a patient receiving five times the intended dose and experiencing severe vomiting.
  • Another provider prescribed 20 units instead of 2 units, affecting three patients who, after receiving 10 times the intended dose, experienced nausea and vomiting.
  • Additionally, a patient, who is a health care provider, attempted to recalculate their own dose in units and inadvertently self-administered a dose 10 times higher than intended.

Conclusion

FDA recognizes the substantial consumer interest in using compounded semaglutide products for weight loss. However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness or quality. Therefore, compounded drugs should only be used to meet a patient’s needs if the patient’s medical needs cannot be met by an available FDA-approved drug.

FDA has received reports of dosing errors from patients and health care providers related to these compounded products. There may be a risk of medication dosing errors due to conversion from milligrams to other units of measurement, availability of compounded semaglutide products in varying concentrations and use of multiple-dose vials.

Some patients sought medical attention or required hospitalization after the medication error. Reported semaglutide overdose adverse events include gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.

Report adverse events to FDA

FDA encourages compounders, health care providers and patients to report adverse events and medication errors associated with compounded semaglutide products to FDA’s MedWatch Adverse Event Reporting program.

  • Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program, or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

[1] FDA is aware that some compounders incorporate additional ingredients, such as cyanocobalamin (Vitamin B-12), pyridoxine (Vitamin B-6), levocarnitine (L-Carnitine) and nicotinamide adenine dinucleotide (NAD), into their semaglutide products. The safety and effectiveness of combining semaglutide with other ingredients has not been established.

[2] FDA had also received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used in the approved drugs, which contain the base form of semaglutide. The FDA is not aware of any basis for compounding using the salt forms that would meet the FD&C Act conditions for types of active ingredients that can be used in compounding.

FDA alerts health care providers, compounders of dosing errors (2024)

FAQs

Is compounded semaglutide safe? ›

But there aren't clinical studies showing that these forms of semaglutide are safe or effective in people. Semaglutide products made with semaglutide salts, chemicals used only for research, or ingredients from unregistered manufacturers do not meet legal FDA safety requirements.

What is the FDA definition of compounding? ›

Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounded drugs are not FDA-approved.

How to find out if a compounding pharmacy is FDA approved? ›

If a prescription calls for a compounded drug, patients can ask whether the compounding pharmacy is accredited. Lists of accredited compounding pharmacies are organized by state on the Pharmacy Compounding Accreditation Board's (PCAB) website.

What is the dark side of semaglutide? ›

Nausea, vomiting, and diarrhea are the most common semaglutide side effects. But they usually subside after a few weeks of using the medication. Although rare, serious side effects are possible. Some may require immediate medical attention, such as pancreatitis and allergic reactions.

Does Ozempic work better than compounded semaglutide? ›

The FDA does not assess how effective compounded drugs are, so it is not known if compounded semaglutide is as effective as Ozempic. In some cases, compounded drugs can be helpful if there is a shortage of FDA-approved drugs or if a drug requires altering to meet someone's specific needs, such as avoiding an allergen.

Is splitting pills considered compounding? ›

Tablet splitting: Compounding involves changes to a finished dose, and splitting tablets alters the finished dose in a way that simply transferring medication to a different package or container does not.

Does insurance cover compounded medications? ›

It is up to the insurance company to decide whether or not a compound will be covered or not. That is why each compounded medication is processed by insurance on a case-by-case basis for payment to be approved.

Are compounded meds safe? ›

Generally speaking, compounded medications can be safe when a reputable compounding pharmacy prepares them. However, as mentioned earlier, it's not possible to ensure their safety, effectiveness, and quality since they don't carry FDA approval .

Why are compounded drugs not FDA-approved? ›

Neither FDA nor state authorities evaluate compounded drugs for safety or efficacy, but compounders cannot just use any chemical to create a new drug. Instead, the FDCA defines the particular active drug ingredients— known as bulk drug substances—that can be used to create compounded drugs.

What are the disadvantages of compounding pharmacy? ›

The disadvantages are the cost, time to make the product, potentially poor-quality products, drug dosing miscalculations, the use of specialized equipment, and non-reporting of adverse effects to the FDA. Compounding medications may pose a public health risk if they are not created properly.

Is compounding pharmacy legitimate? ›

That means many people with legitimate prescriptions from their doctors were unable to get them, except through a compounding pharmacy. Properly compounded versions are legal for anyone with a prescription, says Scott Brunner, CEO of Alliance for Pharmacy Compounding (APC), an advocacy organization.

How much weight can you lose with compounded semaglutide? ›

As you can see, the average weight loss is 7.59 pounds in the first month, 12.86 pounds over the first two months, 18.23 pounds over the first three months, 23.49 pounds over the first four months, 27.27 pounds over the first five months, 32.83 pounds over the first six months, 38.49 pounds over the first seven months ...

Does compounded semaglutide work as well as Wegovy? ›

The FDA has issued a warning against compounded semaglutide, stating "Patients should be aware that some products sold as 'semaglutide' may not contain the same active ingredient as FDA-approved semaglutide products," like Ozempic and Wegovy, and that they "have not been shown to be safe and effective."

How long does compound semaglutide last? ›

Is this medication only good for a month? Despite the label on the bottle stating “discard after 28 days”, the medication is safe to use until the printed expiration date on the vial. After the medication is compounded at the pharmacy, it is shelf stable for 90 days.

Does compounded semaglutide need refrigeration? ›

Compounded semaglutide should be refrigerated if dispensed as a liquid solution for injection. This is because liquids are more prone to degradation and bacterial growth at room temperature. Unused and unopened semaglutide vials should be stored at temperatures from 36-46°F (2-8°C).

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