Wednesday, October 7, 2009

Replacement of Proven Sight-Saving Drug Critical to Protecting Vision in Newborns

Prevent Blindness America Advises Doctors and Expectant Parents to Educate Themselves on Shortage of Erythromycin Ophthalmic Ointment

CHICAGO (Oct. 7, 2009) – Due to a recent change in drug manufacturers, the Centers for Disease Control and Prevention (CDC) has responded to reports of a shortage of Erythromycin Ophthalmic Ointment by offering guidelines on how to obtain a supply. Erythromycin Ophthalmic Ointment is the recommended drug treatment for ophthalmia neonatorum, commonly known as “Babies’ Sore Eyes.” According to the Food and Drug Administration (FDA), Erythromycin Ophthalmic Ointment is also approved for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.

Prevent Blindness America, the nation’s oldest volunteer eye health and safety group, was founded more than 100 years ago as an organization dedicated to eradicating unnecessary vision loss to Babies’ Sore Eyes. At the time, some healthy babies developed blinding eye infections days after birth. It was discovered that administering silver nitrate to the newborn’s eyes immediately after birth successfully prevented the infection from developing. Today, Erythromycin Ophthalmic Ointment is now used instead of silver nitrate.

Bausch and Lomb and Fera Pharmaceuticals are increasing the production of Erythromycin Ophthalmic Ointment in response to the shortage. Currently, the FDA Drug Shortages Web site has information regarding availability of Erythromycin Ophthalmic Ointment at: http://www.fda.gov/Drugs/DrugSafety/DrugShortages

“We cannot stress enough how important it is to make sure we do everything we can to protect the vision of our children,” said Hugh R. Parry, president and CEO of Prevent Blindness America. “Our organization was founded on the belief that all children should have the best possible opportunity for a full lifetime of healthy vision. We applaud the efforts of Bausch & Lomb, Fera Pharmaceuticals, the CDC and the FDA to address this shortage and urge them to do all they can to make sure this important issue is addressed with the highest importance.”

For professionals, the CDC recommends the following to secure supplies:

1. Review your supplies of Erythromycin Ophthalmic Ointment (0.5%) routinely.

2. Reserve current supplies of Erythromycin Ophthalmic Ointment (0.5%) for neonatal prophylaxis use.

3. For normal replacement supplies, contact your wholesale distributor directly.

4. For severely low supplies (i.e., depletion within a week), contact your wholesale distributor or call Bausch and Lomb customer service at 1-800-323-0000 directly. Notify the FDA drug shortage e-mail account (drugshortages@fda.hhs.gov ), if supplies are not available.

5. CDC has consulted with other experts about alternate recommendations for extreme situations where erythromycin ophthalmic ointment is not available. These recommendations are provided at: http://www.cdc.gov/std/treatment/2006/erythromycinOintmentShortage.htm

For more information on the Erythromycin Ophthalmic Ointment shortage or general children’s eye health topics, please call Prevent Blindness America at 1-800-331-2020.

Download the press release
Department of Health and Human Services Letter






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