The Food and Drug Administration is questioning if tobramycin actually does help patients with cystic fibrosis to breathe better. The powdered version of the drug is an alternative to the nebulized version that is called Tobi. The FDA is only questioning the powdered form of the medication.
A company called Novartis makes a drug called Tobi. It is a nebulized version of tobramycin. A nebulizer is an electric, or battery-powered machine that turns liquid medication into a fine mist that an adult or child can inhale into their lungs. Some nebulizers have a mouthpiece, and others have a face mask. A nebulizer is a good choice for young children who are too little to be taught how to properly use an inhaler.
Children who have asthma might be prescribed medication that requires the use of a nebulizer. A nebulizer is also used by children who have cystic fibrosis. The drug called Tobi is specifically prescribed to kids who have cystic fibrosis. It is an antibiotic that treats a lung infection that kids who have cystic fibrosis often get.
The Food and Drug Administration (FDA) is not questioning the drug called Tobi that is used in nebulizers. Instead, it has concerns over the powdered version of tobramycin. The powder is used in inhalers, but not in nebulizers.
Novartis created this version of the antibiotic because it would be faster to use and more convenient for patients. It can be much quicker to use an inhaler than to wait for a nebulizer to finish distributing the proper dose of Tobi in the form of a mist.
The FDA says that it is not clear that the powdered version of tobramycin was as helpful to patients as the liquid version is. Only one of two clinical trials was able to show that the powder worked better than a placebo.
There are also concerns about how well the powdered version will work over time. If the drug is not as effective over time as it was thought to be, it could expose kids who have cystic fibrosis to a risk of getting a lung infection.
This is not to be confused with a different drug that is used to treat cystic fibrosis that the FDA approved earlier this year. Kalydeco was approved in February of 2012 to help treat the cause of cystic fibrosis. It has been approved for use by people who have cystic fibrosis and who are age six or older.
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