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FDA Approves First Needleless “Rescue” Drug for Hypoglycemic Episodes

By EJ Mundell
Health Day Reporter

Thursday, July 25, 2019 (HealthDay News)-What could be a real step forward for Americans Diabetes, Wednesday’s U.S. Food and Drug Administration nodded a needleless way to help people recover from dangerous episodes Hypoglycemia..

A new formulation called Baqsimi contains the rescue drug glucagon, which is being given as a nasal inhalation powder instead, the FDA said.

“People who have ever suffered seriously Hypoglycemia The episode had to be treated with glucagon injections and first had to be mixed in a process of several steps, “explained Dr. Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research.

“It may simplify the process that can be important during the episode,” Baqsimi said in a news release from the agency.

one Diabetes The expert agreed.

Approval of new drug is ” Diabetes There is a risk of Hypoglycemia [hypoglycemia], And for their families and their healthcare providers, “said Dr. Minisha Sud. She is an endocrinologist at Lenox Hill Hospital in New York City.

Sood is for diabetics Hypoglycemia -This means that a friend, family member, or other bystander must administer the injected glucagon.

That meant “training the patient’s friends and family” about how to inject the drug into the muscle, which could be a real “restriction,” she said.

Having a “easier” option than administering glucagon is “a game changer when it comes to treating severe hypoglycemia outside the hospital or clinic,” Sood said. “I’m looking forward to using this for patients.”

As the FDA explained, “Patient’s blood sugar The level drops to a level where he or she becomes confused, unconscious, or suffers from other symptoms that require the help of others to treat. Usually, severe hypoglycemia Diabetes Who is using Insulin process. “

Baqsimi is offered in a disposable dispenser that can be easily administered to deliver powder containing glucagon to the nose.The drug “increases blood sugar Level in the body by stimulating liver To release the stored glucose into the bloodstream, “said the FDA.

Wednesday’s approval was based on the results of two studies of 83 and 70 adults. Diabetes.. Baqsimi was found to function similar to glucagon injected to raise blood sugar level.

Similar results were found in a study of 48 children. Type 1 diabetes, The FDA added.

Eli Lilly and Company’s Bakusimi has some restrictions. According to the FDA, it should not be used by people in rare conditions known as Pheochromocytoma, NS tumor Of people with adrenal glands or pancreas tumor Known as Insulinoma..

Known person allergy Taking glucagon should not take Bakshimi. Also, do not take if you are fasting for a long time or if you have chronic hypoglycemia.

According to the FDA, the side effects of Bakshimi were similar to those of injected glucagon.

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References

Source: Minisha Sood, MD, Endocrinologist, Lenox Hill Hospital, New York City.US Food and Drug Administration, News Release, July 24, 2019

FDA Approves First Needleless “Rescue” Drug for Hypoglycemic Episodes

Source link FDA Approves First Needleless “Rescue” Drug for Hypoglycemic Episodes

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