PITTSBURGH, Pa., Jan. 26, 2015 (GLOBE NEWSWIRE) -- via PRWEB - An Allegheny Health Network clinical trial examining whether intranasal corticosteroids stunt children's growth – the first such trial conducted in accordance with U.S. Food and Drug Administration guidelines - found a small but statistically significant growth reduction for children taking the medication to treat allergic rhinitis, or hay fever.
David P. Skoner, MD , Director of the Division of Allergy, Asthma and Immunology at Allegheny Health Network and lead author of the study, published in the Jan. 26, 2015 online version of the journal Pediatrics, said that while previous clinical trials found the inhaled steroid had no impact on children's growth, those trials were inadequately designed and produced conflicting results. This prompted the FDA to issue new guidelines on evaluating the impact of these medications on children.
"While inhaled triamcinolone is an effective medication that can be used safely, we strongly believe, and the results of this trial confirm, that it should be used only under a doctor's supervision," Dr. Skoner said. "The effects can be insidious and not noticed for several years."
Allergic rhinitis affects an estimated 10 to 40 percent of children worldwide, and inhaled corticosteroids are the most effective treatment option for relieving symptoms. Though children tolerate the medication well, in 1998 the FDA began requiring all intranasal corticosteroid labels to carry a warning about potential systemic side effects, including growth retardation.
In 2013, Dr. Skoner testified before the FDA in opposition to making triamcinolone acetonide nasal spray (brand names include Nasacort) available over the counter. Dr. Skoner was chosen to represent the positions of both the American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI).
Dr. Skoner testified that corticosteroids hold the potential for causing a number of adverse effects including stunting a child's growth, and noted that patients could have access to corticosteroids in other forms, raising the potential for adverse effects. Nasacort was cleared for over-the-counter sales in October 2013.
Kristen Lee, wife of Philadelphia Phillies pitcher Cliff Lee, knows first-hand about the consequences of excessive steroid use. Her daughter Maci, at the age of 6 years, developed growth and life-threatening adrenal gland suppression from long term use of both nasal and inhaled corticosteroids for nasal allergies and suspected asthma.
"Truly unbelievable if this drug makes it over the counter," Mrs. Lee told the FDA in a prepared statement read at the 2013 hearing. "My child will need to be on growth hormone shots every day until she goes through puberty as a result of her growth suppression that never corrected itself."
Mrs. Lee and Dr. Skoner are working together to form a non-profit corporation called Maci's TEAMS (Teaching Everyone About Medication Safety), which will educate physicians and parents about doses and side effects to help keep children safe.
The clinical trial followed 216 children age 3-9 with allergic rhinitis over a 12-month period. They were randomly assigned to either a placebo or once-daily use of triamcinolone acetonide aqueous nasal spray. The average growth velocity for the children who used the nasal spray was 5.65 centimeters per year, as opposed to 6.09 centimeters per year for the children who received a placebo. Studies were conducted at Allegheny General Hospital and numerous other sites nationwide.
"The question of whether the children whose growth was slowed eventually catch up to their peers remains unresolved," Dr. Skoner said. "Some research suggests that growth velocity rebounds somewhat in the long term, however studies that conform to FDA guidelines are needed to confirm this."
"The American Academy of Allergy, Asthma and Immunology believes that this type of research is important for parents and their children to better understand the risk/benefit ratio of using intranasal corticosteroids for the treatment of a very common disorder, allergic rhinitis," said Thomas Casale, MD, Executive Vice President, AAAAI.
"This study shows that an intranasal corticosteroid, triamcinolone, that was just released for OTC use could have a small but significant effect on children's growth. These data support the need to better study medications before decisions are made to switch from prescription to OTC status, especially in regards to potential safety concerns for children."
About Allegheny Health Network:
Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,500 people and has more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.
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