Written by Staff Writer
At least two life-saving drugs will soon no longer be required in patients who receive those who receive treatment for severe asthma, experts announced Tuesday.
Covidien, the company that makes Glucocorticoid Injection Gel, announced last week that it will discontinue the device’s manufacturing after realizing it didn’t provide the level of protection in pediatric patients as it had been intended for adults.
“The new Glucocorticoid Injection Gel does not provide evidence to support an effective dose at infant/pre-adolescent or younger patients, but can provide an effective dose in adult patients,” said Dr. Ajay Jain, professor of medicine and medicine director of the pulmonary division at the Children’s Hospital of Philadelphia and a contributing author of the CHOP Guideline for Inhalation Fungal Antibiotic Therapy with Glucocorticoid Injection Gel.
“Covidien decided not to manufacture Glucocorticoid Injection Gel for pediatric patients so they will discontinue sales of this product next month,” Jain said.
With the GLDH discontinuation, “Millions of children and teens could be without life-saving therapy,” said Dr. Sami Soleimani, a pediatric pulmonologist at Children’s Hospital Los Angeles and pediatrician at the Children’s Toni and James Grant Hospital.
But although GLDH is being phased out, other medications, such as Roxicodone, will continue to be required. An Asthma and Allergy Foundation of America spokesperson explained that by prescription, these medications are used to bring down symptoms in a child with serious asthma. “The Glucocorticoid Injection Gel was only used as a preventive treatment for asthma episodes,” the spokesperson said.
There are many ways to treat and prevent asthma. Glucocorticoid Injection Gel, or many types of inhaled steroids, are generally the most effective treatment but can cause some side effects, including premature aging, lower respiratory function, muscle damage and joint pain.
The Glucocorticoid Injection Gel, is approved for adults with chronic obstructive pulmonary disease (COPD), which causes blood to rise in the lungs, preventing the lungs from working properly. Glucocorticoid Injection Gel is marketed by Covidien as Glucocorticoid Injection Gel NitroPhy-Phenyol; the product is often used to treat chronic asthma in patients who are already on medication to control their asthma and have other conditions.
According to Covidien, the company said it has been working with the Food and Drug Administration (FDA) and regulatory agencies of countries worldwide since late 2016 to re-evaluate the safety and effectiveness of the new Glucocorticoid Injection Gel for pediatric patients, including patients who have never had Glucocorticoid Injection Gel before.
Although Jain stated that the move to discontinue manufacturing for the Glucocorticoid Injection Gel in children is good news, he cautioned that “Other asthma medications are out there for preventing worsening of asthma in children.”