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Health Canada warns consumers
about Sandoz Prednisolone 1% Ophthalmic Suspension
due to potential health risk
May 5, 2006
Health Canada is warning
consumers not to use Sandoz Prednisolone 1% USP
ophthalmic suspension eye drops because of the
possibility that the bottles may mistakenly contain
another product, Blue Collyrium, raising potentially
serious health risks.
The possibility that the bottle
does not contain the correct product was raised
when one bottle from one lot of Prednisolone 1%
USP ophthalmic suspension eye drops was found
to contain Blue Collyrium.
Patients who have been prescribed
Sandoz Prednisolone 1% USP ophthalmic suspension
eye drops should discontinue use of the product
and consult with their physician or health care
practitioner immediately to ensure that treatment
of the underlying condition is not delayed.
As a precautionary measure, patients
should also return the product to the place of
purchase and have the pharmacist confirm that
the 10 ml white plastic bottle they purchased
contains the right product. Prednisolone 1% USP
ophthalmic suspension eye drops are white, while
Blue Collyrium drops are dark blue. It may be
difficult to identify colour differences through
the white bottles. This applies to all lots.
The lot number of the product that
has been found to contain Blue Collyrium is 128832,
with an expiration date of 2007-10. This lot number
can be found on the bottle.
At this time, a recall of the affected
lot has been initiated by Sandoz Canada Incorporated.
The product was distributed across Canada to wholesalers,
pharmacists and hospitals. Although this product
is not indicated for veterinary use, it has also
been distributed to veterinary wholesalers.
Prednisolone 1% USP ophthalmic suspension
eye drops is prescribed in the treatment of conditions
that cause inflammation of the eye and for use
after cataract surgery.
If a patient suffers from eye inflammation
and uses Blue Collyrium instead of the prescribed
Prednisolone 1% USP ophthalmic suspension eye
drops the inflammation will not be treated, which
may lead to severe complications, including damage
to eye tissue and scarring.
Blue Collyrium, used to treat eye
redness caused by minor irritation, is not recommended
for use for more than 72 hours without consulting
a physician. However, Prednisolone 1% USP ophthalmic
suspension eye drops may be used beyond 72 hours.
As a result of the product mix-up, patients would
be exposed to Blue Collyrium for a much longer
period than recommended.
Blue Collyrium is also not recommended
for use in children. Patients with certain medical
conditions, including heart disease, high blood
pressure, asthma, diabetes and thyroid disease
may be at higher risk of adverse effects from
taking Blue Collyrium. To report a lack of efficacy
of treatment or a suspected adverse reaction to
Prednisolone 1% USP ophthalmic suspension, please
contact the Canadian Adverse Drug Reaction Monitoring
Program (CADRMP) of Health Canada by one of the
following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789
CADRMP
Marketed Health Products Directorate
Health Canada
AL 0701C
Ottawa, Ontario, K1A 0K9
Email: cadrmp@hc-sc.gc.ca cadrmp@hc-sc.gc.ca
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