Hair Loss Is a Potential Side Effect of Novel Oral Anticoagulants – Findings From the Dresden Noac Registry (NCT01588119)

Abstract

1173 Background: Among other side effects, hair loss is a frequent complaint in patients receiving anticoagulant therapy with Vitamin-K antagonists (VKA) and sometimes also found in patients receiving low-molecular weight heparin (LMWH). Novel oral anticoagulants (NOAC) such as apixaban, dabigatran or rivaroxaban have been tested in large prospective phase-III trials including over 100.000 patients. Furthermore, after approval more than one million patients have been treated with these novel drugs in daily care. So far, hair loss has not been reported as a side effect of NOAC therapy. Using data from a large monocentric prospective NOAC registry, we evaluated incidence and risk profile of newly reported hair loss in patients receiving dabigatran or rivaroxaban therapy. Objectives: To evaluate the incidence of newly reported hair loss as a potential side effect of NOAC therapy in daily care. Patients and methods: In the district of Saxony, Germany, a network of 200 physicians from private practice and hospitals enrol patients in the prospective NOAC registry. Inclusion criteria are: 1) indication for NOAC anticoagulation >3 month; 2) age > 18 years; 3) written informed consent; 4) availability for follow-up. No Exclusion criteria apply. In the registry, up to 2000 patients will receive prospective follow up (FU) by phone visits at day 30 day and quarterly thereafter to collect efficacy and safety data. Results: Until July 31th 2012, 938 patients were registered. Of these, 730 patients received rivaroxaban for atrial fibrillation (AF) or venous thromboembolism (demographic data in table 1) and 208 received dabigatran for AF. For these patients, current follow up data cumulate to 270.8 patient years of NOAC treatment. During follow-up visits, twelve patients spontaneously reported new hair loss (nine with rivaroxaban, 3 with dabigatran; demographic data in table 1). Therefore, total incidence of newly reported hair loss in our registry is 4.4 per 100 patient years. The mean time between start of NOAC and first report of hair loss was 68±76 days. Despite the fact that all twelve patients were female, uni- and multivariate analysis did not detect any correlation to baseline data including demographic data, co-morbidity or co-medication. Conclusion: In patients receiving long-term NOAC therapy, the incidence of hair loss as a spontaneously reported side effect is around 4.4 per 100 patient years. Before treatment initiation, patients should be informed about this potential side effect. Further data in larger cohorts are necessary to evaluate potential risk factors for hair loss with novel oral anticoagulants. Disclosures: Werth: Bayer Healthcare: Honoraria. Beyer-Westendorf:Bayer Healthcare: Bayer provided a grant to support the NOAC registry in part Other, Honoraria; Boehringer Ingelheim: Boehringer provided a grant to support the NOAC registry in part, Boehringer provided a grant to support the NOAC registry in part Other, Honoraria; Bristol Myers Squibb: Honoraria; Pfizer: Honoraria.

Agent specific effects of anticoagulant induced alopecia

“…9 Loss has been described with the use of rivaroxaban. Findings from the Dresden New Oral Anticoagulant (NOAC) registry report an incidence of 4.4 per 100 patient years, 10 and one associated with dabigatran were found within the French Pharmacovigilance Database. 11 Our patient also experienced hair loss following the initiation of rivaroxaban although the symptom occurred rapidly after initiation, more suggestive of anagen effluvium.…”

Alopecia em pacientes anticoagulados

“…1,2,7,9,10 Characteristics such as older patient age, longer duration of treatment or higher dosage are risk factors associated with the condition and the majority of reports reveal that alopecia is reversed when treatment is withdrawn. 5,[11][12][13][14]…”

“…A prospective registry of 938 patients receiving anticoagulant treatment with rivaroxaban or dabigatran for atrial fibrillation or venous thromboembolism (the Dresden Registry) 12 observed an incidence of spontaneously reported alopecia of 4.4 per 100 patients-year, at a mean time of 68 ± 76 days after administration of these medications and in all cases the patients were female.…”

Venous thromboembolism and women's health

“…The Dresden NOAC registry reported an incidence of alopecia of 4·4 per 100 patient years in spontaneous self‐reports from women prescribed rivaroxaban (9/730) and dabigatran (3/208) following a treatment duration of 22–260 days (Gelbricht et al , ). Whilst this may be considered a non‐significant side effect to physicians, it may lead to patient to non‐adherence (Chrétien et al , ).…”