The Federal Drug Administration (FDA) must approve drugs before they can be prescribed by physicians. The FDA approval specifies the dosages of the drug, the specific diseases and conditions it should be used for, and the age of the patients receiving it. However, once a drug is approved for one purpose or for one age group, doctors can use the drug to treat other diseases or age groups. This type of usage is called "off-label" use.
Fluoroquinolones antibiotics include Cipro, Floxin, Levoquin, and others. The FDA has approved these drugs for many types of infections, but not for use in children under 18 years old. However, it's believed that many doctors use fluoro-quinolones to treat infections in children under 18 years old. These drugs are considered to be a second line antibiotic used when the more common and safer antibiotics fail to work.
Fluoroquinolones have an unusual side effect that other antibiotics don't have - muscle and joint pain. Sometimes these problems can be severe. The FDA found these potential side effects posed too great a risk to growing muscles and bones in children 18 and under.
A French study looked at 276 children 18 and younger who received fluoroquinolones. One third of the children had cystic fibrosis. The children were matched with 249 children on other antibiotics.
Nearly 20% (52 children) of the children taking a fluoroquinolone experienced a side effect compared to 5% (13 children) on other antibiotics. The biggest difference was in musculoskeletal pain - 10 in the fluoro-quinolone group compared to none in the control group. The children in the fluoroquinolone group had a higher rate of all other side effects.
Fluoroquinolones have a role in treating infections in children - but a very limited one. These drugs should not be the first antibiotic used. Other safer antibiotics should be tried. Only if they don't work should fluoroquinolones be used.
Family Practice News, 1/15/03, p.5
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