Is Daflon (micronised diosmin 90% + hesperidin 10%) contraindicated or safe to use during pregnancy for hemorrhoids or chronic venous insufficiency?

Daflon Is NOT Contraindicated in Pregnancy

Daflon (micronised diosmin 90% + hesperidin 10%) is safe to use during pregnancy for hemorrhoids and chronic venous insufficiency, particularly in the third trimester, based on FDA drug labeling and clinical trial evidence showing no adverse effects on pregnancy outcomes, fetal development, or infant growth. 1, 2

FDA Drug Label Position

The FDA-approved drug label for diosmin explicitly states that "a small number of pregnant women have consumed diosmin (up to 900 mg/day) in the third trimester and the first 4 weeks post-partum with no effect on the fetus or baby," and animal studies demonstrate no developmental abnormalities. 1 However, the manufacturer conservatively states that Daflon "is not recommended in pregnant and lactating women" primarily due to limited data rather than evidence of harm, and advises women capable of becoming pregnant to consult their physician before use. 1

Clinical Trial Evidence Supporting Safety

A prospective clinical trial of 50 pregnant women with acute hemorrhoids treated with micronised diosmin 90% and hesperidin 10% (median 8 weeks before delivery and 4 weeks postpartum) demonstrated that treatment "did not affect pregnancy, fetal development, birth weight, infant growth and feeding." 2 This study showed 66% of patients achieved relief from acute symptoms by day 4, with 53.6% fewer patients experiencing relapse during the antenatal period. 2

Animal Safety Data

Extensive animal toxicology studies support the safety profile:

• Teratogenicity studies using 50 and 100 mg/kg/day of diosmin showed no differences in fetal formation, number per litter, weight gain, or developmental milestones. 1
• Chronic dosing studies in rats at doses representing 37 times the recommended human dose showed no impairment of reproductive function or effects on reproductive tissue. 1
• No adverse effects on fertility, embryotoxicity, or perinatal/postnatal development were observed in offspring of treated animals. 1

Clinical Context: Hemorrhoids in Pregnancy

The American Gastroenterological Association notes that hemorrhoids occur in approximately 80% of pregnant women, most commonly during the third trimester due to compression of the rectum by the gravid uterus. 3 While the AGA guideline recommends hydrocortisone foam for third-trimester hemorrhoids (showing no adverse events in 204 patients), 3 it does not specifically address Daflon, which has its own evidence base.

Reconciling Conservative Labeling with Clinical Evidence

The discrepancy between the manufacturer's conservative recommendation against use and the clinical evidence of safety reflects a common pharmaceutical industry practice: drugs are frequently labeled as not recommended during pregnancy for legal reasons when specific large-scale studies have not been performed, rather than due to evidence of harm. 3 The European Society of Cardiology guidelines explicitly note that "manufacturers' instructions are mainly based on the fact that drugs are not tested sufficiently during pregnancy and breastfeeding. For this and for legal reasons, drugs are frequently considered prohibited during pregnancy and breastfeeding." 3

Practical Clinical Algorithm

For pregnant women with hemorrhoids or chronic venous insufficiency:

1. First-line approach: Dietary fiber (30 g/day), adequate hydration, bulk-forming agents (psyllium, methylcellulose), and osmotic laxatives (polyethylene glycol, lactulose) for constipation management. 3

2. Second-line approach: If conservative measures fail and symptoms are severe, Daflon can be considered, particularly in the third trimester where the most robust safety data exists. 1, 2

3. Dosing: The studied regimen is 900 mg/day (typically given as 500 mg twice daily), which can be used for up to 8 weeks before delivery and 4 weeks postpartum. 2

4. Alternative for hemorrhoids: Hydrocortisone foam has demonstrated safety in the third trimester and may be used concurrently. 3

Important Caveats

• Lactation: Effects in nursing infants are uncertain for chronic dosing, so the manufacturer does not recommend use during breastfeeding. 1
• First trimester: While animal data shows no teratogenicity, human data is primarily from third-trimester use, so exercise greater caution in early pregnancy. 1, 2
• Shared decision-making: Given the conservative manufacturer labeling, discuss both the clinical evidence of safety and the limited data with patients to support informed consent. 1