What is the pregnancy category of Optidex (dexamethasone) eye drops?

Pregnancy Category of Optidex (Dexamethasone) Eye Drops

Dexamethasone ophthalmic solution (Optidex) is classified as FDA Pregnancy Category C, indicating potential risk to the fetus that must be weighed against potential benefits to the mother.

Understanding FDA Pregnancy Category C

Category C medications have the following characteristics 1:

• Animal studies have revealed adverse effects on the fetus
• No adequate and well-controlled studies exist in pregnant women
• Potential benefits may warrant use despite potential risks

Evidence for Dexamethasone's Pregnancy Classification

The FDA drug label for dexamethasone ophthalmic solution clearly states 2:

• Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application
• In animal studies, corticosteroids produced:
  • Fetal resorptions
  • Cleft palate in mice
  • Multiple abnormalities involving the head, ears, limbs, and palate in rabbits

Clinical Implications for Pregnant Patients

Risk Assessment

• Topically applied ophthalmic corticosteroids can be absorbed systemically
• Infants born to mothers who received substantial doses of corticosteroids during pregnancy should be monitored for signs of hypoadrenalism 2

Recent Safety Data

• A 2020 study examining topical ophthalmic corticosteroids in pregnant women with allergic conjunctivitis found no significant association with adverse neonatal outcomes including:
  • Congenital anomalies
  • Preterm birth
  • Low birthweight 3

Management Recommendations

When considering dexamethasone eye drops during pregnancy:

1. Use only if clearly needed: Prescribe only when potential benefits justify the potential risks to the fetus
2. Consider alternatives: For pregnant patients requiring ophthalmic anti-inflammatory treatment:
   • Brimonidine has a Pregnancy Category B rating, making it potentially safer 1, 4
   • Beta-blockers are often used during pregnancy due to long-term clinical experience 1
3. Minimize systemic absorption:
   • Use lowest effective dose
   • Apply punctal occlusion (pressing on the inner corner of the eye after drop instillation)
   • Wipe excess medication from cheek

Important Considerations for Nursing Mothers

The FDA label also warns 2:

• Topically applied steroids are absorbed systemically
• Due to potential for serious adverse reactions in nursing infants, consider:
  • Discontinuing nursing, or
  • Discontinuing the medication
  • Base decision on importance of the drug to the mother

Clinical Context

While the FDA pregnancy category system provides important guidance, it's worth noting that the FDA has transitioned to a new Pregnancy and Lactation Labeling Rule that provides more descriptive information rather than letter categories 1. However, older medications like dexamethasone still retain their original letter classifications in most clinical references.

Remember that the risk-benefit assessment should consider the severity of the mother's ophthalmic condition and potential consequences of leaving it untreated.