Ciprofloxacin approved for complicated UTI in children

If recent events are any indication, fluoroquinolones may remain the domain of adults and only an off-label option for most children with serious diseases, according to Lisa Saiman, MD, of Columbia University in New York.
One fluoroquinolone, ciprof- loxacin (Cipro, Bayer), has been approved as a second-line drug for use in children older than 1 year for complicated urinary tract infections (UTI) and pyelonephritis.
Bristol-Myers Squibb, the makers of another fluoroquinolone, gatifloxacin (Tequin), was seeking a pediatric indication to treat respiratory infections like acute otitis media. That application was pulled last month by the company after the FDA requested a risk management plan be set in place before the drug’s approval for recurrent otitis media, according to company officials.
The risk management plan sought to address many pediatricians’ questions about the fluoroquinolones’ potential for toxicity and resistance, but a company spokeswoman said that the FDA and the company could not agree on what type of plan would best address those questions.
General pediatricians remain opposed to fluoroquinolones’ use in children because they are concerned about the potential risk to the developing osteoarticular system, Saiman said.
She spoke on the topic of fluoroquinolone use in children at the 14th Annual Society for Healthcare Epidemiology of America (SHEA) Scientific Meeting here recently.(Infectious Diseases in Children, July 2004)

Orlistat: A new drug for obese adolescents
FDA approves Orlistat for obese adolescents
The FDA has recently approved the use of orlistat (Xenical, Roche) to treat obesity in adolescents between the ages of 12 and 16. This is the first approval of this kind of prescription weight-loss treatment for adolescents.
The FDA approval was based on results of a clinical trial that examined the safety and efficacy of orlistat in obese adolescents. The 54-week trial included a cohort of 539 obese adolescent patients, and compared orlistat treatment with placebo.
Patients in the cohort were randomized to receive either orlistat or placebo. Patients in the orlistat group received doses of 120 mg three times per day with meals. This dosage is similar to the dose that is approved for adults. Patients who were treated with orlistat were also given a reduced-calorie diet that contained no more than 30% of calories from fat compared with those given placebo.
The average age of participants in both groups was 13.5 years; the average weight was 210 pounds.
At the end of the 54-week trial, patients in the orlistat group had significant reductions in body mass index (BMI) compared with patients in the placebo group. Among the patients in the orlistat group, 27% had a reduction in BMI of 5% or more. In comparison, 16% of patients in the placebo group achieved this level of weight loss.
Orlistat is a weight loss medication that promotes weight loss by reducing dietary fat absorption by about 30%.