Check here regularly for news from the North Shore-LIJ/Cohen Children's Medical Center Cystic Fibrosis Center team.
We are reviewing our infection control guidelines since the CFF is finalizing new guidelines. You may see changes in the outpatient and inpatient settings. Thank you in advance for your cooperation, as we implement these changes in the New Year.
FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients
The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. Cystic fibrosis causes the body to produce thick, sticky mucus that builds up in the lungs and blocks airways. The buildup of mucus makes it easy for bacteria like P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Many patients with cystic fibrosis are treated with antibiotics using a nebulizer machine.
TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.
"Today's approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for P. aeruginosa," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler."
TOBI Podhaler's effectiveness was established in a study of 95 pediatric and adult patients with cystic fibrosis. All patients were 6 years of age or older and infected with P. aeruginosa. Patients were randomly assigned to receive TOBI Podhaler or a placebo for the first 28 days of the study. All patients then received treatment with TOBI Podhaler for the remainder of the study.
The study was designed to determine the improvement in lung function by measuring the change in forced expiratory volume in one second (FEV1). Patients treated with TOBI Podhaler experienced a statistically significant increase of 12.5 percent in FEV1 compared to 0.09 percent in patients treated with placebo. Additional data supporting safety and effectiveness were available from other studies enrolling 487 patients.
Common side effects reported in patients treated with TOBI Podhaler during the clinical studies included cough, including a cough that produces phlegm or mucus; coughing up of blood (hemoptysis); lung disorder; shortness of breath; fever; mouth and throat pain; changes in voice volume or quality (dysphonia); and headache.
TOBI Podhaler is marketed by East Hanover, N.J.-based Novartis.
For more information:
FDA Approved Drugs: Questions and Answers
NIH: Cystic Fibrosis
Listen to Dr. Germana on
Dr. Joan Germana was interviewed on Island Outlook for the Long Island Radio Group. The interview aired on WHLI, WKJY, WBZO and WIGZ on April 29, 2012.
Steven and Alexandra Cohen Children’s Center/Long Island Jewish Medical Center honored at the North American Cystic Fibrosis Conference.
Steven and Alexandra Cohen Children's Center/Long Island Jewish Medical Center was honored at the North American Cystic Fibrosis Conference, being named one of eleven centers to earn the 2010-2011 Quality Care Award. These awards honor centers that excel at the following quality improvement performance standards:
Patient Assistance Resource Library
To help you navigate the complex world of health insurance and healthcare coverage, the CFF Patient Assistance Resource Library (http://www.cff.org/LivingWithCF/AssistanceResources/Library/) offers a range of useful information, including:
Mother of CF Patient Receives Prestigious Recognition
Maryann O'Mahony is the recipient of 2010 Long Island MVP award from the Greater New York Chapter of the Cystic Fibrosis Foundation. Many thanks to Maryann for her tremendous work in CF, and congratulations on this well-deserved recognition.