A health watchdog cautioned the public
against using eye drops that are not registered with the Food and Drugs
Administration (FDA).
against using eye drops that are not registered with the Food and Drugs
Administration (FDA).
The EcoWaste Coalition sounded the alarm after procuring an unregistered eye
drop product costing P100 from a self-styled “eye doctor” who does his business
at the sidewalk of Rizal Avenue in Santa Cruz, Manila.
drop product costing P100 from a self-styled “eye doctor” who does his business
at the sidewalk of Rizal Avenue in Santa Cruz, Manila.
The product “Herbal Eye Drop Wild Sampaguita Extract,” which comes in
small plastic bottle with blue cap and label,” supposedly cleanses and removes
bacteria from the eyes.
small plastic bottle with blue cap and label,” supposedly cleanses and removes
bacteria from the eyes.
“With cases of sore eyes on the rise and with the supply of eye drops
reportedly getting scarce, some sufferers may be tempted to use this product
whose quality and safety is dubious,” said Thony Dizon, Coordinator of the
EcoWaste Coalition’s Project Protect.
reportedly getting scarce, some sufferers may be tempted to use this product
whose quality and safety is dubious,” said Thony Dizon, Coordinator of the
EcoWaste Coalition’s Project Protect.
“Given the proliferation of unregistered health products in the market, it’s
important for consumers to know how to spot the untrustworthy eye drops,” he
said.
important for consumers to know how to spot the untrustworthy eye drops,” he
said.
Citing the “Herbal Eye Drop Wild Sampaguita Extract” as an example, Dizon cited
the following as red flags that vigilant consumers should know about: no
manufacturer and/or importer information, no ingredients’ list, no instruction
on usage and no precautionary statement.
the following as red flags that vigilant consumers should know about: no
manufacturer and/or importer information, no ingredients’ list, no instruction
on usage and no precautionary statement.
Dizon pointed out that while the label indicated “BFAD No. FR 40738,” the
product as per FDA website is not registered.
product as per FDA website is not registered.
He added that although the label specified March 2016 as the expiration date,
no information was provided on the product’s date of manufacturing and lot
number.
no information was provided on the product’s date of manufacturing and lot
number.
The FDA had previously advised consumers “that the use of unregistered eye
drops present safety risks and adverse health consequences.”
drops present safety risks and adverse health consequences.”
“The use of unregistered eye drops may result in inflammation, irritation,
infection of the eye or loss of vision,” the FDA warned.
infection of the eye or loss of vision,” the FDA warned.
This year, the FDA issued several advisories banning the sale and use of the
following unregistered eye drops mostly imported from India:
following unregistered eye drops mostly imported from India:
1. Carboxymethyl Cellulose Sodium + Glycerin (Tearbright Plus) 10 mL Eye
Drops
Drops
2. CMD Eye Drop 15 ml.
3. Gatifloxacin + Prednisolone Acetate (Gatsun-P) 5 mL Eye Drops
4. Latanoprost Ophthalmic Solution (Latanobright) Eye Drops 2.5 mL
5. Moxifloxacin Hydrochloride (Moxibright) 5 mL Eye Drops
6. Moxifloxacin Hydrochloride + Dexamethasone Sodium Phosphate
(Moxibright DM) 5 mL Eye Drops
(Moxibright DM) 5 mL Eye Drops
7. Moxifloxacin Hydrochloride (Occumox) 5 mL Eye Drops
8. Naphazoline Hydrochloride + Zinc Sulphate + Chlorpheniramine Maleate
(Naphabright) Eye Drops 10 mL
(Naphabright) Eye Drops 10 mL
9. Olopatadine Hydrochloride (Patabright) Eye Drops 5 mL
10. Potassium Iodide + Calcium Chloride (Catabright Plus) Eye
Drops 5 mL
Drops 5 mL
“The abovementioned drug products pose potential danger or injury to the
consuming public and the importation, selling or offering for sale of such is
in direct violation of Republic Act No. 9711 or the Food and Drug
Administration Act of 2009,” the advisories stated.
consuming public and the importation, selling or offering for sale of such is
in direct violation of Republic Act No. 9711 or the Food and Drug
Administration Act of 2009,” the advisories stated.
The EcoWaste Coalition on Saturday went drug store-hopping in Rizal Avenue near
Jose Reyes Memorial Hospital in search of the above unregistered eye drops, and
was relieved not to find them being sold in the area.
Jose Reyes Memorial Hospital in search of the above unregistered eye drops, and
was relieved not to find them being sold in the area.
-end-
Reference:
http://www.fda.gov.ph/advisories-2/pharmaceutical-2/258754-fda-advisory-no-2015-052-public-health-warning-against-the-use-of-the-following-unregistered-drug-products
http://www.fda.gov.ph/advisories-2/pharmaceutical-2/250145-fda-advisory-no-2015-34