FDA ISSUES WARNING ON MISUSE OF LASER POINTERS
FDA
HHS _NEWS_
_U.S. Department of Health and Human Services_
_________________________________________________________________
P97-45 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Sharon Snider: 301-827-6242
December 18, 1997 Broadcast Media: 301-827-3434
Consumer Inquires: 800-532-4440
FDA ISSUES WARNING ON MISUSE OF LASER POINTERS
The Food and Drug Administration is warning parents and school
officials about the possibility of eye damage to children from
hand-held laser pointers.
These products are generally safe when used as intended by teachers
and lecturers to highlight areas on a chart or screen. However, recent
price reductions have led to wider marketing, and FDA is concerned
about the promotion and use of these products as children's toys.
The light energy that laser pointers can aim into the eye can be more
damaging than staring directly into the sun. Federal law requires a
warning on the product label about this potential hazard to the eyes.
"These laser pointers are not toys. Parents should treat them with the
appropriate care," said FDA Lead Deputy Commissioner Michael A.
Friedman, M.D. "They are useful tools for adults that should be used
by children only with adequate supervision."
FDA's warning is prompted by two anecdotal reports it has received of
eye injury from laser pointers--one from a parent, the other from an
ophthalmologist.
Momentary exposure from a laser pointer, such as might occur from an
inadvertent sweep of the light across a person's eyes, causes only
temporary flash blindness. However, even this can be dangerous if the
exposed person is engaged in a vision-critical activity such as
driving.
FDA
HHS _NEWS_
_U.S. Department of Health and Human Services_
_________________________________________________________________
P97-46 FOOD AND ADMINISTRATION
For Immediate Release Susan M. Cruzan: 301-827-6242
December 22, 1997 BROADCAST MEDIA: 301-827-3434
Consumer Inquires: 800-532-4440
FDA Approves Inhaled Antibiotic for Management Of Cystic Fibrosis Patients
The Food and Drug Administration today has announced approval of the
first inhaled antibiotic for patients with cystic fibrosis. The new
product, tobramycin solution for inhalation (Tobi) is used to suppress
pseudomonas aeruginosa in the airways of patients with cystic
fibrosis. Pseudomonas aeruginosa is a dangerous microorganism that
affects the lungs or respiratory system of most of the 30,000 cystic
fibrosis patients in the United States.
Cystic fibrosis is an inherited condition that causes thick mucous
secretions in the lungs, resulting in severely diminished lung
function and chronic lung infections. Tobramycin, which was first
approved in l975 in injection form was reformulated for inhalation to
reduce side effects associated with systemic therapy.
The new form of the antibiotic was designated as an orphan drug and
will receive incentives under the Orphan Drug Act of l983. It was
approved in less than 6 months under an accelerated procedure of the
Prescription Drug User Fee Act (PDUFA), the agency's user fee program.
"This is an important new therapy for cystic fibrosis patients," said
Lead Deputy Commissioner Michael A. Friedman, M.D. "It also shows the
benefits of FDA's Orphan Program and demonstrates the effectiveness of
our fast track procedures for medicines for serious diseases."
The new formulation of tobramycin was proven safe and effective in two
placebo-controlled trials of about 500 patients with the chronic
condition. The trials demonstrated improvement in lung function and
reduction of the bacteria in sputum. The drug was administered, often
in combination with other standard therapies, in a regimen of 28 days
on drug and 28 days without drug therapy to reduce the potential for
drug resistance.
Side effects reported in clinical trials included voice alteration and
tinnitus (ringing in the ears).
Tobi will be marketed by PathoGenesis Corporation of Seattle,
Washington.