AAP Newsaapnews.aappublications.org
1. Published online September 8, 2009
(doi: 10.1542/aapnews.20090908-1)

NEWS AND FEATURES

Copyright © 2009, The American Academy of Pediatrics
Guidance issued on erythromycin ophthalmic ointment shortage
1. Joseph A. Bocchini Jr., M.D., FAAP
A serious national shortage of 0.5% erythromycin ophthalmic ointment has resulted in some hospitals depleting their
supplies of this product and others having only a limited supply available.
To address the shortage, the Food and Drug Administration (FDA) has developed guidance on securing additional
supplies of 0.5% erythromycin ophthalmic ointment, and the Centers for Disease Control and Prevention (CDC) has
made interim recommendations for prophylaxis when 0.5% erythromycin ophthalmic ointment is not available.
Erythromycin ophthalmic ointment is used across the United States in newborn infants for prophylaxis of ophthalmia
neonatorum due to Neisseria gonorrhoeaeand Chlamydia trachomatis. The other two products with efficacy
against N. gonorrhoeae, 1% tetracycline ophthalmic ointment and 1% silver nitrate, are no longer available in the
United States.
Fera Phamaceuticals recently acquired the rights to 0.5% erythromycin ophthalmic ointment from Fougera, which
ceased its production. Fera expects to have this product back to market in 2010. Bausch and Lomb, the other major
manufacturer of the 1 gram tubes of 0.5% erythromycin ophthalmic ointment used for neonatal prophylaxis, is
increasing its production to help alleviate the shortage. However, this ointment is expected to be in short supply for at
least a few months.
Bausch and Lomb will distribute its product through the following wholesalers identified on the FDA Web site:
AmerisourceBergen, Cardinal Health Inc. and McKesson Corp. (5mg/gram in a 1 gram tube, package of 50, NDC
24208-0910-19 and 3.5 gram tube, package of 1, NDC 24308-0910-55). Providers should contact the distributors
directly to order supplies. The FDA has recommended that in addition to the 1 gram tubes, all 3.5 gram tubes of 0.5%
erythromycin ophthalmic ointment be used only for neonatal eye prophylaxis during this shortage.
Providers are encouraged to visit the FDA’s Drug Shortages Web site, which will be updated regularly with
information on the availability of erythromycin ophthalmic ointment, www.fda.gov/Drugs/DrugSafety/DrugShortages,
and to e-mail the FDA at drugshortages@fda.hhs.gov if adequate supplies are not available from distributors.
No other FDA-approved products are available for ophthalmia neonatorum prophylaxis. However, based on available
pharmacological data and current susceptibility patterns of isolates of N. gonorrhoeae in the United States, the CDC
has developed recommendations for providing prophylaxis when 0.5% erythromycin ophthalmic ointment is not
available, www.cdc.gov/std/treatment/2006/erythromycinOintmentShortage.htm.
AzaSite (azithromycin ophthalmic solution 1%) is recommended as an acceptable substitute. One to two drops of this
product are placed in each conjunctival sac. Because it is a solution rather than an ointment, care must be taken to
ensure the drops are placed properly. The CDC recommends that two people provide the prophylaxis — one to hold
the lids open and the other to instill the drops.
If azithromycin ophthalmic solution 1% is not available, gentamicin or tobramycin ointments are recommended for
consideration. Lastly, if none of the previously mentioned alternatives are available, ciprofloxacin ophthalmic ointment
0.3% can be considered as a less suitable but acceptable alternative. In most cases, potential resistance of N.
gonorrhoeae to ciprofloxacin will be overcome by the high concentrations of ciprofloxacin achieved.
Since there are no data on safety or efficacy of any of the mentioned alternative products, infants who have received
an alternative regimen should be monitored for side effects and failures. Care should be taken at the 48- to 72-hour
post neonatal discharge visit to evaluate for evidence of ophthalmia neonatorum. Testing for N. gonorrhoeae should
be included in the evaluation of all infants who present with ophthalmia neonatorum. A prophylaxis failure or
significant adverse event should be reported to local health departments and the CDC.
Resources
For more information, e-mail Roxanne Barrow, M.D., at the CDC, at RBarrow@cdc.gov, or e-mail the FDA
at drugshortages@fda.hhs.gov.
Current information on the shortage can be found on the AAP Member Center under Current News, and includes
links to information from the FDA, CDC and the American Society of Health-System Pharmacists.
Treatment recommendations for ophthalmia neonatorum due to N. gonorrhoeae and C. trachomatis can be found in
the 2009 Red Book, pages 827-829.
Footnotes

Dr. Bocchini chairs the AAP Committee on Infectious Diseases.
CDC Guidance on Shortage of
Erythromycin (0.5%) Ophthalmic
Ointment
Update March 4, 2010
The FDA has indicated that the erythromycin ophthalmic ointment shortage has been resolved.
Erythromycin ophthalmic ointment (0.5%) is the only CDC recommended therapy for prophylaxis
of ophthalmia neonatorum available in the United States. The alternative recommended therapies
suggested during the shortage should no longer be used. Providers are strongly encouraged to
locate and obtain erythromycin ophthalmic ointment. For current information regarding the
availability of this product, see the FDA website
athttp://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm .
Update February 5, 2010
The FDA has updated information on the availability of erythromycin ophthalmic ointment. Fera
Pharmaceuticals has begun to release product for the 50 x 1 gm packaging configuration. Bausch &
Lomb continues to release product for the 50 x 1 gm packaging configuration. For additional
information, visit the FDA Drug Shortage Website
(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
).
Update December 9, 2009
According to FDA, erythromycin ophthalmic ointment (1 gram tube) is currently available to meet
the historical demand for this product. The current rate of production is expected to continue into
the first quarter of 2010. However, it is important at this time for customers to limit their order to
quantities that meet their immediate needs. The production rate is expected to further increase
after the first quarter of 2010 to a level that allows customers to build inventory. See the FDA Drug
Shortage website (http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm ) for
additional information.
Update October 21, 2009
Since the October 7, 2009 update (below), the FDA continues to receive reports, now from 11
states, of adverse reactions associated with the use of gentamicin ophthalmic ointment . The
reports are related to the use of gentamicin ophthalmic ointment from several lots. The cases
continue to involve lid swelling and dermatitis, appearing soon after or a few days after ointment
application. Most cases have been mild and have not required additional treatment. Some cases
were more severe and were associated with blistering of the skin. The conjunctiva, orbital contents
and cornea were not involved in any cases, and all cases resolved within approximately 2 weeks
without sequelae. The experts collaborating with CDC on these alternative recommendations are
unclear about the exact cause of the adverse effects. Until the etiology is known, it may be
reasonable to limit the contact exposure of gentamicin ophthalmic ointment on the skin.
Gentamicin ophthalmic ointment should be used with caution and used only if acceptable
alternatives, as described below, are not available. These adverse events will continue to be
investigated by the FDA. Providers should continue to report adverse events to FDA MedWatch
(http://www.fda.gov/Safety/MedWatch
).
Erythromycin ophthalmic ointment is currently available through the major wholesalers and should
be the first option for prophylaxis of ophthalmia neonatorum. Providers are strongly encouraged to
locate and obtain this product. Bausch and Lomb has increased its production of erythromycin
ophthalmic ointment (1 gm tube) and is expected to meet demand by the end of October. In an
effort to ensure equitable distribution of product and to minimize spot shortages, providers should
order product based on short term need only. Alternative recommendations should only be used if
erythromycin ophthalmic ointment can not be obtained. See the FDA website
(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm ) for more information
on obtaining erythromycin ophthalmic ointment.
Update October 7, 2009
FDA has received reports from a few locations of adverse events associated with use of gentamicin
ophthalmic ointment as an alternative for prophylaxis of ophthalmia neonatorum, given the
shortage of erythromycin ophthalmic ointment. The reports are related to the use of Gentak
(Gentamicin Ophthalmic Ointment) 0.3%, Akorn, from several lots. The cases involve lid swelling
and dermatitis, appearing a few days after ointment application. Most cases have been mild and
have not required additional treatment. Some cases were more severe and were associated with
blistering of the skin. The conjunctiva, orbital contents nor cornea were involved in any cases, and
all cases resolved without complication. These adverse events are being investigated by the FDA.
The probability of this dermatitis occurring cannot be reliably estimated at this time. There is
anecdotal experience from a hospital where several cases were described, that wiping excess
ointment off the eyelids seems associated with a milder reaction, when it occurs. Providers and
hospitals should make efforts to obtain erythromycin ophthalmic ointment so that alternative
preparations will not be needed. They can also consider the use of other alternatives such as
AzaSite (Azithromycin Ophthalmic Solution) 1%, Inspire Pharmaceuticals. However, experts
continue to regard gentamicin ophthalmic ointment as an acceptable alternative. Bausch and
Lomb, the manufacturer of erythromycin ophthalmic ointment (0.5%, 1 gram tube), anticipates
that sufficient quantity to meet full market demand will be available by the end of October.
Providers should continue to report adverse events following administration of alternative methods
of neonatal eye prophylaxis to FDA MedWatch (http://www.fda.gov/Safety/MedWatch
).
Update September 25, 2009
Bausch & Lomb is releasing product for the 50 x 1 gm packaging configuration, with projections to
meet demand in October 2009. All product manufactured in the 50 X 1 gram configuration will be
allocated to all of Bausch & Lomb's established wholesalers and distributors. Fera Pharmaceuticals
recently acquired the rights to manufacture this product and is actively working to make it
available again. See the FDA website
(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
) for updated
information.
CDC continues to work with the U.S. Food and Drug Administration (FDA) and other experts to
provide updates regarding the shortage of Erythromycin Ophthalmic Ointment (0.5%). This page
provides guidance on securing supplies and recommendations for preventing increases in the
occurrence of ophthalmia neonatorum during the shortage.
To secure supplies, we recommend the following over the next several weeks:
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 below.
If Erythromycin Ophthalmic Ointment (0.5%) is not available, we recommend
the following:
1. Our experts indicate that AzaSite® (Azithromycin Ophthalmic Solution 1%, Inspire
Pharmaceuticals) is an acceptable alternative, if Erythromycin Ophthalmic Ointment (0.5%) is
not available.
a.
There are no clinical data on efficacy of this product for the prophylaxis of ophthalmia
neonatorum; the recommendation is made on the basis of available data on pharmacology
and gonococcal microbiologic sensitivity.
b.
AzaSite® is not FDA approved for this indication.
c.
Use is recommended whether the infant is delivered vaginally or by cesarean section.
d.
The recommend dose is 1-2 drops placed in the conjunctival sac of each eye, taking care to
not touch the applicator tip to the infant. Because this is a solution rather than an
ointment, it is important to assure that drops are placed properly. Consider a two person
administration approach– one to hold the eye lids open and the other to administer the
medication.
2. The following are acceptable alternatives if neither AzaSite® (Azithromycin Ophthalmic
Solution 1%, Inspire Pharmaceuticals) nor Erythromycin Ophthalmic Ointment (0.5%) is
available:
a.
Gentak® (Gentamicin Ophthalmic Ointment 0.3%, Akorn) or
b.
Tobrex® (Tobramycin Opththalmic Ointment 0.3%, Alcon Laboratories).
c.
If none of these preparations are available, a fluoroquinolone ophthalmic ointment:
Ciloxan® (Ciprofloxacin Ophthalmic Ointment 0.3%, Alcon Laboratories) can be used, but
this is a less suitable alternative given data on possible gonococcal antimicrobial resistance.
d.
Caveats “a” through “c” outlined in item 1 above also apply for these alternatives.
3. Betadine (povidone iodine) is not recommended primarily because of the potential confusion
with and possible use of the more familiar detergent formulation, which could be quite harmful.
4. Since efficacy data are not available for any of the suggested alternate regimens, providers
should be alert to the possibility of failure of prophylaxis;
a.
Providers are strongly encouraged to follow the AAP recommendation that infants be seen
for their first postnatal office visit 48-72 hours post discharge from the hospital.
(PEDIATRICS Vol. 120 No. 6 December 2007, pp. 1376), and to examine closely for
ophthalmia neonatorum.
b.
Testing for N. gonorrhoeae should be included for all infants who present with ophthalmia
neonatorum, and reports of prophylaxis failure sent to local health departments and to
CDC.
5. An alternative or additional approach is to test mother for gonorrhea and chlamydia prior to
delivery, with prompt follow-up. The 2006 STD Treatment Guidelines outlines recommended
prophylactic treatment for infants whose mothers have gonococcal infection and for
management of infants born to mothers who have untreated chlamydia. Empiric treatment is
recommended for infants exposed to gonorrhea (page 48)1, while monitoring for development
of symptoms prior to initiating treatment is recommended for infants exposed to chlamydia
(page 42)2. Screening mothers will allow providers to identify infants with known exposure
(www.cdc.gov/std/treatment).
 CDC point of contact: Dr. Roxanne Barrow (RBarrow@cdc.gov).

FDA Resources:
o
FDA - Drug Shortages
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
o
FDA - Erythromycin Ophthalmic Ointment Shortage
http://www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/ucm181113.htm
o
FDA drug shortage e-mail account: (drugshortages@fda.hhs.gov) for additional inquiries
about the shortage.
1 For gonorrhea: Ceftriaxone 25-50mg/kg IV or IM, not to exceed 125 mg, in a single dose
2 For Chlamydia: Erythromycin base or Ethylsuccinate 50mg/kg/day orally divided into 4 doses
daily for 14 days
CDC Guidance on Shortage of
Erythromycin (0.5%) Ophthalmic
Ointment
Update March 4, 2010
The FDA has indicated that the erythromycin ophthalmic ointment shortage has been resolved.
Erythromycin ophthalmic ointment (0.5%) is the only CDC recommended therapy for prophylaxis
of ophthalmia neonatorum available in the United States. The alternative recommended therapies
suggested during the shortage should no longer be used. Providers are strongly encouraged to
locate and obtain erythromycin ophthalmic ointment. For current information regarding the
availability of this product, see the FDA website
athttp://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm .
Update February 5, 2010
The FDA has updated information on the availability of erythromycin ophthalmic ointment. Fera
Pharmaceuticals has begun to release product for the 50 x 1 gm packaging configuration. Bausch &
Lomb continues to release product for the 50 x 1 gm packaging configuration. For additional
information, visit the FDA Drug Shortage Website
(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
).
Update December 9, 2009
According to FDA, erythromycin ophthalmic ointment (1 gram tube) is currently available to meet
the historical demand for this product. The current rate of production is expected to continue into
the first quarter of 2010. However, it is important at this time for customers to limit their order to
quantities that meet their immediate needs. The production rate is expected to further increase
after the first quarter of 2010 to a level that allows customers to build inventory. See the FDA Drug
Shortage website (http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm ) for
additional information.
Update October 21, 2009
Since the October 7, 2009 update (below), the FDA continues to receive reports, now from 11
states, of adverse reactions associated with the use of gentamicin ophthalmic ointment . The
reports are related to the use of gentamicin ophthalmic ointment from several lots. The cases
continue to involve lid swelling and dermatitis, appearing soon after or a few days after ointment
application. Most cases have been mild and have not required additional treatment. Some cases
were more severe and were associated with blistering of the skin. The conjunctiva, orbital contents
and cornea were not involved in any cases, and all cases resolved within approximately 2 weeks
without sequelae. The experts collaborating with CDC on these alternative recommendations are
unclear about the exact cause of the adverse effects. Until the etiology is known, it may be
reasonable to limit the contact exposure of gentamicin ophthalmic ointment on the skin.
Gentamicin ophthalmic ointment should be used with caution and used only if acceptable
alternatives, as described below, are not available. These adverse events will continue to be
investigated by the FDA. Providers should continue to report adverse events to FDA MedWatch
(http://www.fda.gov/Safety/MedWatch
).
Erythromycin ophthalmic ointment is currently available through the major wholesalers and should
be the first option for prophylaxis of ophthalmia neonatorum. Providers are strongly encouraged to
locate and obtain this product. Bausch and Lomb has increased its production of erythromycin
ophthalmic ointment (1 gm tube) and is expected to meet demand by the end of October. In an
effort to ensure equitable distribution of product and to minimize spot shortages, providers should
order product based on short term need only. Alternative recommendations should only be used if
erythromycin ophthalmic ointment can not be obtained. See the FDA website
(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm ) for more information
on obtaining erythromycin ophthalmic ointment.
Update October 7, 2009
FDA has received reports from a few locations of adverse events associated with use of gentamicin
ophthalmic ointment as an alternative for prophylaxis of ophthalmia neonatorum, given the
shortage of erythromycin ophthalmic ointment. The reports are related to the use of Gentak
(Gentamicin Ophthalmic Ointment) 0.3%, Akorn, from several lots. The cases involve lid swelling
and dermatitis, appearing a few days after ointment application. Most cases have been mild and
have not required additional treatment. Some cases were more severe and were associated with
blistering of the skin. The conjunctiva, orbital contents nor cornea were involved in any cases, and
all cases resolved without complication. These adverse events are being investigated by the FDA.
The probability of this dermatitis occurring cannot be reliably estimated at this time. There is
anecdotal experience from a hospital where several cases were described, that wiping excess
ointment off the eyelids seems associated with a milder reaction, when it occurs. Providers and
hospitals should make efforts to obtain erythromycin ophthalmic ointment so that alternative
preparations will not be needed. They can also consider the use of other alternatives such as
AzaSite (Azithromycin Ophthalmic Solution) 1%, Inspire Pharmaceuticals. However, experts
continue to regard gentamicin ophthalmic ointment as an acceptable alternative. Bausch and
Lomb, the manufacturer of erythromycin ophthalmic ointment (0.5%, 1 gram tube), anticipates
that sufficient quantity to meet full market demand will be available by the end of October.
Providers should continue to report adverse events following administration of alternative methods
of neonatal eye prophylaxis to FDA MedWatch (http://www.fda.gov/Safety/MedWatch
).
Update September 25, 2009
Bausch & Lomb is releasing product for the 50 x 1 gm packaging configuration, with projections to
meet demand in October 2009. All product manufactured in the 50 X 1 gram configuration will be
allocated to all of Bausch & Lomb's established wholesalers and distributors. Fera Pharmaceuticals
recently acquired the rights to manufacture this product and is actively working to make it
available again. See the FDA website
(http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
) for updated
information.
CDC continues to work with the U.S. Food and Drug Administration (FDA) and other experts to
provide updates regarding the shortage of Erythromycin Ophthalmic Ointment (0.5%). This page
provides guidance on securing supplies and recommendations for preventing increases in the
occurrence of ophthalmia neonatorum during the shortage.
To secure supplies, we recommend the following over the next several weeks:
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 below.
If Erythromycin Ophthalmic Ointment (0.5%) is not available, we recommend
the following:
1. Our experts indicate that AzaSite® (Azithromycin Ophthalmic Solution 1%, Inspire
Pharmaceuticals) is an acceptable alternative, if Erythromycin Ophthalmic Ointment (0.5%) is
not available.
a.
There are no clinical data on efficacy of this product for the prophylaxis of ophthalmia
neonatorum; the recommendation is made on the basis of available data on pharmacology
and gonococcal microbiologic sensitivity.
b.
AzaSite® is not FDA approved for this indication.
c.
Use is recommended whether the infant is delivered vaginally or by cesarean section.
d.
The recommend dose is 1-2 drops placed in the conjunctival sac of each eye, taking care to
not touch the applicator tip to the infant. Because this is a solution rather than an
ointment, it is important to assure that drops are placed properly. Consider a two person
administration approach– one to hold the eye lids open and the other to administer the
medication.
2. The following are acceptable alternatives if neither AzaSite® (Azithromycin Ophthalmic
Solution 1%, Inspire Pharmaceuticals) nor Erythromycin Ophthalmic Ointment (0.5%) is
available:
a.
Gentak® (Gentamicin Ophthalmic Ointment 0.3%, Akorn) or
b.
Tobrex® (Tobramycin Opththalmic Ointment 0.3%, Alcon Laboratories).
c.
If none of these preparations are available, a fluoroquinolone ophthalmic ointment:
Ciloxan® (Ciprofloxacin Ophthalmic Ointment 0.3%, Alcon Laboratories) can be used, but
this is a less suitable alternative given data on possible gonococcal antimicrobial resistance.
d.
Caveats “a” through “c” outlined in item 1 above also apply for these alternatives.
3. Betadine (povidone iodine) is not recommended primarily because of the potential confusion
with and possible use of the more familiar detergent formulation, which could be quite harmful.
4. Since efficacy data are not available for any of the suggested alternate regimens, providers
should be alert to the possibility of failure of prophylaxis;
a.
Providers are strongly encouraged to follow the AAP recommendation that infants be seen
for their first postnatal office visit 48-72 hours post discharge from the hospital.
(PEDIATRICS Vol. 120 No. 6 December 2007, pp. 1376), and to examine closely for
ophthalmia neonatorum.
b.
Testing for N. gonorrhoeae should be included for all infants who present with ophthalmia
neonatorum, and reports of prophylaxis failure sent to local health departments and to
CDC.
5. An alternative or additional approach is to test mother for gonorrhea and chlamydia prior to
delivery, with prompt follow-up. The 2006 STD Treatment Guidelines outlines recommended
prophylactic treatment for infants whose mothers have gonococcal infection and for
management of infants born to mothers who have untreated chlamydia. Empiric treatment is
recommended for infants exposed to gonorrhea (page 48)1, while monitoring for development
of symptoms prior to initiating treatment is recommended for infants exposed to chlamydia
(page 42)2. Screening mothers will allow providers to identify infants with known exposure
(www.cdc.gov/std/treatment).
 CDC point of contact: Dr. Roxanne Barrow (RBarrow@cdc.gov).

FDA Resources:
o
FDA - Drug Shortages
http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
o
FDA - Erythromycin Ophthalmic Ointment Shortage
http://www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/ucm181113.htm
o
FDA drug shortage e-mail account: (drugshortages@fda.hhs.gov) for additional inquiries
about the shortage.
1 For gonorrhea: Ceftriaxone 25-50mg/kg IV or IM, not to exceed 125 mg, in a single dose
2 For Chlamydia: Erythromycin base or Ethylsuccinate 50mg/kg/day orally divided into 4 doses
daily for 14 days