Wed Sep 15, 2004
ROCKVILLE, Md. (Reuters) - Warning labels for certain steroid-based allergy and asthma drugs provide sufficient warnings about potential side effects -- including stunted growth -- in children and teenagers, a U.S. panel of medical experts concluded on Wednesday.
The Food and Drug Administration advisory panel reviewed safety information related to several allergy and asthma drugs, including GlaxoSmithKline Plc's Advair, Flonase and Flovent and AstraZeneca Plc's Pulmicort/Rhinocort.
"We do not have concerns about the use of these drug products as labeled," said panel chair Joan Chesney, head of academic programs at St. Jude Children's Research Hospital in Memphis, Tennessee.
The committee's evaluation focused in part on studies of medicines containing steroids called budesonide or fluticasone that are delivered via nose sprays or oral inhalers.
Panelists looked at reports of suspected side effects sent to the FDA in the year after the medicines were approved for pediatric use.
Current labels for the steroidal drugs already include precautions about possible growth problems, and panelists agreed with FDA staff reviewers who said warnings for that side effect and others already were already adequately represented on packages. Other reported problems included nausea, vomiting, cataracts and cardiac arrest, among others.
"At this point we believe that the current labeling for these drugs is concurrent with latest safety data," Peter Starke, an FDA team leader for the agency division that oversees lung-related drugs, told the experts.
Panelists also said they saw no need to add any new safety information to the label for Glaxo's Cutivate, a topical steroid for dermatitis.
The experts also reviewed safety information for other non-steroid drugs used to treat children with allergies, bacterial conjunctivitis, osteoporosis, and leukemia, but did not express concern about any potential side effects.
Those drugs included Schering-Plough Corp's allergy drug Clarinex, Allergan Inc's eye drug Ocuflox, Schering AG unit Berlex's Fludara and Merck & Co. Inc.'s Fosamax for osteoporosis.