Fondaparinux should be used cautiously in geriatric patients, particularly in those 75 years of age and older. Renal clearance in this population is reduced by roughly 25% and accumulation of the unbound, active drug may lead to serious adverse events, including major bleeding. The risk of major bleeding increases with age. During clinical prophylaxis trials in patients with hip fracture, or hip or knee replacement surgery, major bleeding occurred in % of adult patients less than 65 years of age, in % of those 65—74 years, and in % of those 75 years of age and older. Similarly, during clinical prophylaxis trials with fondaparinux after abdominal surgery, major bleeding occurred in 3% (19/644) of patients less than 65 years of age, in % (16/507) of patients aged 65—74 years of age, and in 5% (14/282) of patients aged 75 years of age or older. In the DVT and PE treatment clinical trials, the risk of fondaparinux-associated major bleeding increased with age: % in patients less than 65 years of age, % of those 65—74 years, and % of those 75 years of age and older. Renal parameters should be assessed prior to use of fondaparinux in the elderly; in addition, careful attention to dosing directions and concomitant medications that affect hemostasis is advised. According to the Beers Criteria, fondaparinux should be avoided in geriatric patients with a creatinine clearance (CrCl) less than 30 mL/min due to an increased risk of bleeding.
The chief adverse reactions were due to the weak androgenic action of ND, such as hoarseness and hirsutism. Despite the lack of adequate methodology for voice evaluation, the prevalence of hoarseness was lower than the average reported in previous clinical trials, whereas the prevalence of hirsutism on patients who received ND and placebo was similar to that in the other studies. Hassager and colleagues ( 30 ) related hoarseness in 11 of the 14 women who received ND every 3 weeks for 1 year, whereas, of the 11 who received it every 4 weeks, only 4 presented changes. In another clinical study, Need and colleagues ( 20 ) reported hoarseness in 20 (48%) of the 42 women who received 50 mg ND every 2 weeks for approximately months and in 2 (5%) of the 38 who received 50 mg ND every 3 weeks for months. Other authors, using populations and ND doses similar to those described previously ( 19 , 23 , 39 ), also detected no significant changes in voice, body hair, or facial hair.
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