|
OPHTHALMOLOGY TIMES
THE GLAUCOMA ANGLE
COLUMN #39
CATCHING UP ON SIDE EFFECTS
Introduction - Robert Ritch, MD
A brief report
in the American Journal of Ophthalmology caught my attention as I was
writing this column.[Rowe, 1997 #11294] The authors describe single
cases of ocular hypotony with choroidal effusion, recurrent cystoid
macular edema, and facial rash in patients taking latanoprost.
Hypertrichosis and increased pigmentation of eyelashes have recently
been reported.[Johnstone, 1997 #11295][Wand, 1997 #11186] We have seen
pseudophakic patients who developed uveitis after taking latanoprost
and reports of uveitis and cystoid macular edema have been surfacing
on the Internet. Are these real side effects or are they coincidental?
Are they due to drug interactions? Can you prove a side effect is a
side effect without retesting. How can we connect rare or
idiosyncratic side effects with a drug?
The National Registry of Drug-Induced Ocular Side effects is a
repository of such reports and is a valuable source of information not
only for the clinician wishing to verify whether an unusual side
effect has been noted by others, but as a source for data collection
in the case of serious or unusual side effects. If not for the
National Registry, our awareness of the association between aplastic
anemia and carbonic anhydrase inhibitors might have taken much longer
to surface.[Fraunfelder, 1985 #7301] Numerous reports of side effects
of antiglaucoma and other drugs have been possible only
ophthalmologists reported them to the Registry.[Van Buskirk, 1980
#7013][Van Buskirk, 1984 #11296][Fraunfelder, 1994 #11298; Fraunfelder,
1995 #11297][Macarol, 1994 #11299][Alder, 1995 #11300]
Ophthalmologists are urged to use this service and to report unusual
side effects.
The National Registry of Drug-Induced Ocular Side
Effects is Alive and Well
Frederick T. Fraunfelder, M.D.
Director
National Registry of Drug-Induced Ocular Side
Effects
Casey Eye Institute, Portland, OR.
Who is probably the leading authority on the ocular side effects of
chloroquine and hydroxychloroquine? - Mike Easterbrook, M.D., Toronto,
Canada; Who is probably the leading authority on tamoxifen? - Mike
Gorin, M.D., Pittsburgh, PA; Who is probably the leading authority on
the side effects on a recently released ocular medication? - We like
to think it’s the National Registry of Drug-Induced Ocular Side
Effects.
With a new drug, spontaneous reporting systems may have insights
into possible adverse effects before other sources. In a specialized
area of medicine, such as ophthalmology, one may not see the volume of
patients necessary to draw a correlation between a particular drug and
its side effects. A national registry to correlate suspicions from a
large volume of ophthalmologists may provide early clues as to a
possible association. If a number of these “possible” associations
are found with a particular drug, especially if they form a pattern,
then more definitive studies can be undertaken. Unfortunately, these
definitive studies are seldom done due to lack of funding.
The National Registry, established in 1975, was an attempt to act
as a clearing house for suspected adverse reactions of drugs used by
ophthalmologists. In some cases, this “pooled” data might allow us
to more rapidly recognize these events. The objectives of the Registry
are:
- To establish a national center where possible drug-induced
ocular side
effects from ophthalmologists can be accumulated;
- To add to this data base the spontaneous reporting data of
possible drug-
induced ocular side effects collected from the Food and Drug
Administration (FDA) (Rockville, MD) and the World Health Organization
(WHO) (Uppsula, Sweden);
- To compile the data in the world literature on reports of
possible drug-
induced ocular side effects in humans;
- To publish some of this data every 4 to 5 years in book form;
To make available this data to physicians who feel they have
noted a
possible drug-induced ocular side effect.
Ophthalmologists are encouraged to send us suspected drug-related
adverse events if associated with a new drug, or rare or unusual
events with established drugs. If a trend is identified, you will be
put in contact with others (your name not released without your
permission) for possible publication. We are not adverse to helping
clinicians with legal questions, since 25% to 35% of physicians’
medicolegal problems may be related to side effects of drugs. We also
field questions for clinicians with questions on possible drug-related
side effects in their patients. This latter service is funded, in
part, by the American Academy of Ophthalmology.
Reports can be mailed: National Registry of Drug-Induced Ocular
Side Effects,
Casey Eye Institute, 3375 SW Terwilliger Blvd, Portland, OR
97201-4197
Or faxed: (503) 494-6864
Or e-mailed: fraunfel@ohsu.edu
When sending data, it would be ideal to include: name of drug,
dosage, length of time on drug, suspected reaction, what happened if
the drug was stopped, if rechallenged, concomitant drugs, name and
address of person reporting case optional, but encouraged. The
Registry is especially interested in receiving cases of blood
dyscrasias associated with the use oral carbonic anhydrase inhibitors
(acetazolamide - Diamox¨, methazolamide - Neptazane¨).
For example, based on data in the Registry and world literature,
what is our current opinion of side effects possibly associated with
latanoprost?
Systemic Probable Possible Unlikely
Dermatologic Reaction _
Flu-like Symptoms _
Fatigue _
Headaches _
Post-menopausal Spotting _
Local
Cystoid macular edema _
Anterior uveitis _
Hypotony - choroidal effusions _
Changes in iris color _
Eyelashes - increased number, _
length, curly, coarse, darkening
Eyelids - increased or decreased _
skin pigmentation
Decreased vision _
Allergic reactions _
Irritation - epiphora, hyperemia, -
pain, foreign body sensation
Superficial punctate keratitis _
Latanoprost is an excellent drug, and the above reactions are, in
the main, reversible. Cystoid macular edema, while not proven to be
caused by latanoprost, certainly is suspect. Thus far, possible
latanoprost associated CME has been reversible when the drug was
stopped. In rare instances, latanoprost may cause uveitis. Some feel
the drug may reactivate patients who previously have had uveitis. This
has not been proven, but the drug is suspect. Iris pigment
proliferation, while not a major concern as far as malignancy, is more
of a concern on long-term therapy as to the potential for inducing
pigmentary glaucoma. Only long-term studies will answer this question.
To our knowledge, brominidine tartrate 0.2%, a new selective alpha-adrenergic
antagonist, has minimal cardiovascular side effects. Even so, it
should be used with caution in patients with severe cardiovascular
disease, cerebral or coronary insufficiency, peripheral vascular
insufficiencies, or orthostatic hypotension. Patients complain of dry
mouth, ocular injection and ocular burning or stinging. Allergic
reactions may occur in up to 10% of patients. One major side effect
appears to be drowsiness. Possible interactions with monoamine oxidase
inhibitors and tricyclic antidepressants, however, is another. Only
with the help of the broader community of ophthalmologists, submitting
detailed reports, with retesting when possible, will our rapid
awareness of these and other side effects be possible.
[ About NYGRI ][ Education ][ Glaucoma Network ]
[ How You Can Help ][ Question Corner ][ Research ]
|