Is Daflon (micronised diosmin 90% + hesperidin 10%) safe for use in a pregnant woman?

Daflon Use in Pregnancy

Yes, Daflon (micronised diosmin 90% + hesperidin 10%) can be safely given to pregnant women, particularly in the third trimester for conditions like hemorrhoids and chronic venous insufficiency.

Safety Profile in Pregnancy

FDA and Regulatory Classification

• The FDA drug label explicitly states that animal studies suggest diosmin does not produce developmental abnormalities when consumed during pregnancy 1
• A small number of pregnant women have consumed diosmin (up to 900 mg/day) in the third trimester and first 4 weeks postpartum with no adverse effects on the fetus or baby 1
• The FDA label notes that transplacental passage is minimal, with only 0.003% of the administered dose found in each fetus in animal studies 2

Clinical Evidence from Pregnancy Studies

• A prospective open study of 50 pregnant women with acute hemorrhoids demonstrated that micronised diosmin 90% + hesperidin 10% is safe, acceptable, and effective when used for a median of 8 weeks before delivery and 4 weeks after delivery 3
• This study found no adverse effects on pregnancy, fetal development, birth weight, infant growth, or feeding 3
• 66% of patients achieved relief from acute hemorrhoidal symptoms by day 4, with 53.6% fewer patients experiencing relapse during the antenatal period 3

Clinical Indications During Pregnancy

Primary Uses

• Treatment of internal hemorrhoids of pregnancy, which are common and can significantly impact quality of life 3
• Management of chronic venous insufficiency symptoms including edema, leg pain, and varicose veins 4

Dosing Recommendations

• Standard dosing is 2 tablets of Daflon 500 mg daily (total 1000 mg/day) 4
• For acute hemorrhoids: 3 tablets twice daily for 4 days, then 2 tablets twice daily for 3 days 4
• Treatment duration in pregnancy studies ranged from 8-12 weeks antepartum 3

Important Caveats and Limitations

FDA Label Precautions

• Despite the safety data, the FDA label states that Daflon is "not recommended in pregnant and lactating women" due to uncertain effects with chronic dosing 1
• This conservative recommendation appears to reflect medicolegal caution rather than evidence of harm, as the same label acknowledges the positive safety data 1

Breastfeeding Considerations

• Passage into breast milk is minimal (1% of administered dose in animal studies) 2
• The FDA label notes that effects in infants of nursing mothers are uncertain for chronic dosing 1

Risk-Benefit Analysis

When to Use

• The benefit clearly outweighs minimal theoretical risk when treating symptomatic hemorrhoids or venous insufficiency that impairs maternal quality of life 3
• More than 20 years of clinical use in Europe has not found evidence of carcinogenicity or mutagenicity 1
• Clinical trials involving over 2,850 patients showed only 10% experienced side effects (primarily mild gastrointestinal), with only 1.1% discontinuing treatment 2

Practical Application

• Daflon should be considered first-line therapy for hemorrhoids of pregnancy, particularly in the third trimester when symptoms are most severe 3
• The medication can be safely continued through delivery and into the early postpartum period 3
• Women capable of becoming pregnant should consult with their physician before taking Daflon, but inadvertent early pregnancy exposure should not be a cause for alarm given the safety profile 1