FDA Approves First Generic Drug for Hypoglycemia


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Key Takeaways

  • The first generic version of the hypoglycemia drug, glucagon, has been approved by the U.S. Food and Drug Administration.
  • The emergency injectable should be available in about two months.
  • Experts say the potentially lower price could increase access to patients who should have the medication on hand.

Last week, the U.S. Food and Drug Administration (FDA) approved glucagon, the first generic medication to treat severe hypoglycemia. The injectable medication can help those with very low blood sugar, which can occur in people with diabetes. It will be packaged as an emergency kit intended for use when blood sugar drops to dangerous levels.

Injectable glucagon has been approved in the U.S. for more than two decades, but there hasn’t been an authorized generic version of the drug. It is equivalent to Eli Lily’s Glucagon Emergency Kit for Low Blood Sugar, which involves mixing a powder into a liquid.

“There are several new forms of glucagon, but most of them are expensive,” Nathan A. Painter, a professor at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Science, tells Verywell. “The approval of a generic option should help with access to glucagon and lower the cost. It is an important option to have available in the case of severe hypoglycemia.”

Painter thinks more people with diabetes will be able to get access to glucagon with the FDA’s approval. Amphastar Pharmaceuticals, the company that produces the medication, said in a statement the kits will be released in about two months.

Many healthcare providers are not always aware of the availability of glucagon, and people with diabetes many not always tell their provider if they have experienced a severe hypoglycemia event, he says.

“This will hopefully bring light to the importance of glucagon,” Painter adds.

Better Affordability

The generic option may not eliminate concerns about being able to afford the medication, as many people with diabetes already have problems affording the medication. But Painter thinks having the generic available should improve cost concerns for some people.

The approval of the generic version of glucagon means that there could soon be inexpensive emergency glucagon kits for people with diabetes, says Danny Hung-Chieh Chou, PhD, an assistant professor of pediatrics in endocrinology at Stanford University School of Medicine in California.

“More people with diabetes should be able to get and afford it due to the expected price drop of the products,” Chou tells Verywell.

Currently, many people may opt out of having expensive emergency glucagon on hand since they don't always need to use the medication, notes Mary-Elizabeth Patti, MD, a doctor who heads up the hypoglycemia clinic at the Joslin Diabetes Center in Boston, Massachusetts.

What This Means For You

Individuals with diabetes will be able to start getting the emergency hypoglycemia medication, likely at a reduced price, in about two months.

Understanding Hypoglycemia

When diabetic patients experience a drop in blood sugar, it can cause hypoglycemia. The person may become unconscious and need help from someone else to restore sugar levels.

The generic glucagon is a synthetic version of glucagon, a hormone made in our bodies that can boost blood sugar levels quickly. It slows the movement of the gastrointestinal tract. Typical side effects include swelling at the injection site, vomiting, nausea, and a brief raise in heart rate.

Typically, severe hypoglycemia occurs in people with diabetes who are using insulin, Painter says.

Many people with diabetes are instructed to eat or drink 15 grams of carbohydrates if their blood sugar falls under 70 mg/dl, and to re-check their levels after 15 minutes. Those carbs can be from glucose products, sugar, juice, or honey. If blood glucose remains low, they should repeat those steps, Painter says. But if a person is going through a severe episode of hypoglycemia and is unconscious, they may not be able to chew or swallow.

“Especially if a person with diabetes is a child, being treated with insulin, or has a history of severe hypoglycemia, it is important to have glucagon on hand,” Painter says. Severe hypoglycemia is a medical emergency and may not be able to be managed using the aforementioned protocol, he adds.

Using Glucagon

Oral glucose/sugar is always first-line treatment for mild to moderate hypoglycemia, says Margaret Eckert-Norton, PhD, a nurse practitioner and adjunct faculty member at St. Joseph's College in New York.

Anyone who experiences frequent signs and symptoms of hypoglycemia should discuss potential underlying reasons for these events and arrange for a glucagon administration kit and education about appropriate use, Eckert-Norton tells Verywell.

It is always best to avoid hypoglycemia and treat it early should it occur,” Eckert-Norton says. “Whether a brand name or generic preparation, glucagon can be life-saving and may prevent hospitalization.”

Eckert-Norton says glucagon should be used if a person is not responding to the usual oral treatment. If someone feels like they will pass out or showing changes in behavior and/or confusion, give the person glucagon and do not wait for a person to lose consciousness. Unconscious individuals will respond to glucagon in five to 10 minutes after receiving it, she adds.

Eckert-Norton does not think there are disadvantages to the generic medication’s approval so long as prescribers continue to educate persons with diabetes and their families about appropriate use of this rescue medication.

“Usually, generic medications are more affordable and more likely to be covered by insurers at a lower copay,” Eckert-Norton adds.

2 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia. December 28, 2020

  2. American Diabetes Association. Hypoglycemia (Low Blood Sugar).

By Kristen Fischer
Kristen Fischer is a journalist who has covered health news for more than a decade. Her work has appeared in outlets like Healthline, Prevention, and HealthDay.