October 2009




Effectively managing eye medications during pregnancy

by Vanessa Caceres EyeWorld Contributing Editor


Uncertainty affects ophthalmologists’ best practices

Even though pregnancy and nursing may be a delicate time in the life of female patients, it’s also a time that causes uncertainty among the ophthalmologists who treat them. Despite guidance from the U.S. Food and Drug Administration (FDA) on the risk of using certain medications, some drugs have not yet been evaluated. Plus, some ophthalmologists believe that the topical nature of many eye medications does not pose the same risk as the systemic usage that’s usually under consideration by the FDA.

One approach is to consult with the patient’s obstetrician/ gynecologist for more guidance, said J.E. “Jay” McDonald, M.D., Fayetteville, Ark. This is an approach he takes when treating pregnant patients with corneal infections.

“I call the doctor and discuss the pros and cons, and he guides me with my antibiotic,” he said.

However, if the patient has cataracts, Dr. McDonald will explain that cataract removal is an elective procedure that can wait until the baby is born. “I’ve never had anyone with cataracts so bad that she could not wait,” he said.

Here’s a rundown of some common treatments for pregnant and nursing patients with dry eye, allergies, and glaucoma. Plus, read on for information on the FDA’s plans to revamp prescription drug labeling to provide more information about the effects of medicine used during pregnancy and breast feeding.

Dry eye and allergies

Esen K. Akpek, M.D., associate professor of ophthalmology, and director, Ocular Surface Diseases and Dry Eye Clinic, Wilmer Eye Institute, Johns Hopkins University, Baltimore, will defer medical treatment in patients who are already pregnant or planning to become pregnant. “I prefer punctal plugs and over-the-counter artificial tears,” she said.

Some of her common treatments for patients with tear film dysfunction/dry eye include artificial tears, steroids, and cyclosporine emulsion (Restasis, Allergan, Irvine, Calif.). The former two are thought to be fine for these patients but the risk of the Restasis is unknown, she said.

Even still, Leonard Bielory, M.D, professor of medicine, pediatrics, ophthalmology and visual sciences, and director, Division of Allergy, Immunology and Rheumatology, UMDNJ-New Jersey Medical School, Newark, N.J., does not have a problem prescribing Restasis for tear film dysfunction. The problem sometimes is explaining the concept of ophthalmic cyclosporine versus the systemic medication.

“When you mention cyclosporine to primary care physicians, they get concerned. They read the package insert and see it’s used for transplantation,” he said. However, he points out that the systemic absorption of the ophthalmic version is almost nil. “It’s reasonable to be used if the patient is comfortable with it,” he said.

Dr. Bielory feels the same way about prescribing topical drops for ocular allergies. “There’s a slimmer chance of exposure and systemic effects than with the oral medications. I’m clearly comfortable with most eye drops,” he said. Dr. Bielory said this approach for eye problems is in contrast with what he sees in asthma patients he also treats, in whom the risk from certain inhaled drugs is definitively higher. He’ll also explain to patients and their physicians that hormonal changes may exacerbate tear film dysfunction and allergies and that they may not need the medications after pregnancy.

Treating glaucoma

Treating pregnant patients with glaucoma may raise more concerns because of the risks of these drugs. “The key to managing female patients of child-bearing age with glaucoma is to discuss the issues of pregnancy and glaucoma before they become pregnant,” said Robert J. Campbell, M.D., Department of Ophthalmology, Queen’s University, Kingston, Ontario. “This is critical because many of the issues can be more effectively dealt with if adjustments in therapy are initiated before pregnancy.”

Because none of the glaucoma medications are shown to be safe in humans, Dr. Campbell recommends reducing the number of medications to an absolute minimum level in any patient who is pregnant or wants to become pregnant. “This requires a careful assessment of the target IOP and an assessment of the risk of rapid progression should IOP be higher,” he said. One factor working in favor of treating pregnant patients is that their IOP tends to lower; however, this is not universally the case, he added. Leon W. Herndon, M.D., associate professor of ophthalmology, Duke Eye Center, Durham, N.C., tends to stop all therapy during the patient’s first trimester and tries to have her avoid using drops if at all possible during pregnancy and while breastfeeding.

Patients on brimonidine and beta blockers should stop medication use a few weeks before delivery, Dr. Campbell said, as brimonidine can cause severe problems such as apnea in neonates.

Dr. Campbell believes that laser trabeculoplasty is a reasonable option for female patients who are looking to get pregnant. “Ideally this would be carried out well before becoming pregnant, as the onset of effect is not immediate and not consistent,” he said. Dr. Herndon also will consider selective laser trabeculoplasty.

If surgery is absolutely necessary during pregnancy, Dr. Campbell recommends performing it during the second trimester, when the fetus is less susceptible to drug exposures and the patient can still tolerate lying horizontally for surgery.

Two recent published reports have tackled the area of risk related to glaucoma medications. An article published online in the British Journal of Ophthalmology in August 2009 addressed the risk of low birthweight. Investigators, led by Jau-Der Ho, M.D., Ph.D., Department of Ophthalmology, Taipei Medical University Hospital, Taipei, Taiwan, analyzed the birthweights of infants born to 244 pregnant women who had been prescribed topical medication for glaucoma. The comparison group had 1,952 women matched for age, year of delivery, maternal hypertension, and diabetes. Investigators found no significant difference in the risk of low birthweight infants between mothers who had used beta blockers versus mothers in the comparison group. However, mothers using topical glaucoma medications other than beta blockers had a significantly higher risk of low birthweight infants. Beta blockers are currently a category C drug according to the FDA’s classifications. Nearly 78% of the mothers studied were on a beta blocker; others were using brimonidine tartrate, topical carbonic anhydrase inhibitors, cholinergics, or prostaglandin analogs.

A case report published last year in the June/July 2009 issue of the Journal of Glaucoma tracked the concentration of timolol in the breast milk of a woman treated for glaucoma. (Dr. Campbell was a co-investigators with this study.) The study found the dose of timolol, even when administered in both eyes, is unlikely to cause systemic side effects in a healthy breastfed infant. However, the investigators added that all nursing infants with cardiopulmonary disease should be monitored for beta blockade when the mothers are using beta-blocker eye drops. Plus, the patient was using a combination brimonidine tartrate/timolol drug, so the actual timolol concentration may be higher in patients using other medications, study investigators added.

FDA’s planned revisions

The FDA hopes to add some clarity to the debate over which drugs may or may not be safe for pregnant and nursing mothers when they update their drug labeling related to these areas. The proposed changes would provide a Pregnancy and Lactation subsection in drug labeling and include a risk summary and a discussion of the data supporting the summary. “The labeling would also include relevant clinical information useful for counseling pregnant or lactating women about medications and prescribing and managing use of those medications,” according to information on the FDA Web site.

The proposed changes would eliminate the drug categories of A, B, C, D, and X and would also eliminate the Labor and Delivery subsection, as that information would be included in the Pregnancy subsection.

The proposed rule is in response to an older classification system that is thought by many doctors to be confusing and simplistic and not reflective of newer information, according to the FDA Web site.

FDA officials have been reviewing comments to the proposed rule since late August 2008, and it’s not yet known when a final rule will be published, according to an FDA spokeswoman.

More information on the FDA proposed rule can be found at www.fda.gov/BiologicsBloodVaccines.

Editors’ note: Drs. Akpek, Bielory, Campell, and Herndon have no financial interests related to their comments.

Contact information

Akpek: 410-955-5494, esakpek@jhmi.edu
Bielory: 973-972-2762, bielory@umdnj.edu
Campbell: recampbell2004@yahoo.ca
Herndon: 919-684-6622, leon.herndon@duke.edu

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