Medication Monitor

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  • April 9, 2013


    Treatment of pregnancy-related nausea and vomiting that cannot be managed by changes in diet and lifestyle

    FDA has approved doxylamine succinate–pyridoxine hydrochloride as the only category A drug for nausea and vomiting drug to pregnancy. Doxylamine succinate–pyridoxine hydrochloride is a delayed-release tablet intended for women who have not responded adequately to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications. These modifications include eating several small meals instead of three large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.

    The drug was studied in 261 women experiencing nausea and vomiting due to pregnancy. Study participants in the clinical trial were at least 18 years old and had been pregnant for at least 7 weeks and up to 14 weeks. Women were randomly assigned to receive 2 weeks of treatment with doxylamine succinate–pyridoxine hydrochloride or a placebo. Women taking the drug experienced greater improvement in nausea and vomiting than those taking placebo. Additionally, observational (epidemiological) studies have shown that the combination of active ingredients does not pose an increased risk of harm to the fetus.

    Doxylamine succinate–pyridoxine hydrochloride is taken daily. Tablets must be taken whole on an empty stomach. The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one midafternoon, and two at bedtime).

    Drowsiness or sleepiness, which can be severe, is the most common adverse effect reported. Women should avoid taking the medication when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.

  • January 4, 2016

    FDA approved lesinurad to treat hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI).

    Lesinurad works by helping the kidney excrete uric acid. It does this by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney.

    Safety and efficacy for lesinurad were evaluated in three randomized, placebo-controlled studies in combination with a XOI involving 1,537 participants for up to 12 months. Participants treated with lesinurad in combination with a XOI experienced reduced serum uric acid levels compared with those on placebo.

    The most common adverse reactions in clinical trials were headache, influenza, increased blood creatinine, and gastroesophageal reflux disease.

    Lesinurad has a boxed warning that provides important safety information for health professionals, including the risk for acute kidney failure, which is more common when used without an XOI and with higher than approved doses of lesinurad.

    FDA is also requiring a postmarketing study to further evaluate the renal and cardiovascular safety of lesinurad.

  • October 22, 2015

    Patiromer for oral suspension has received FDA approval for treatment of hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.

    Hyperkalemia typically occurs in patients with acute or chronic kidney disease or heart failure, particularly in those who are taking drugs that inhibit the renin-angiotensin-aldosterone system, which regulates blood pressure and fluid balance in the body.

    Patiromer for oral suspension, a powdered medication that patients mix with water and take by mouth, works by binding potassium in the gastrointestinal tract, decreasing its absorption. In clinical trials, patiromer was effective in lowering potassium levels in hyperkalemic participants with chronic kidney disease on at least one drug that inhibited the renin–angiotensin–aldosterone system.

    In clinical trials, the most common adverse reactions reported by participants taking patiromer were constipation, decreased magnesium levels in the blood, diarrhea, nausea, abdominal discomfort, and flatulence. Use of the agent is not appropriate for rapid correction of severe hyperkalemia because lowering of serum potassium may take hours to days.

    Patiromer has a boxed warning because it binds many other orally administered drugs, which could decrease their absorption and reduce their effects. The warning recommends taking it and any other orally administered medication at least 6 hours apart.

    The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

  • January 12, 2015

    FDA has approved the anticlotting drug edoxaban to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem.

    Edoxaban also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anticlotting drug administered by injection or infusion for 5 to 10 days.

    Safety and efficacy of edoxaban in treating patients with atrial fibrillation not caused by cardiac valve disease was studied in a clinical trial of 21,105 participants.The trial compared two dose levels of edoxaban with the anticlotting drug warfarin for their effects on rates of stroke and dangerous blood clots.

    Trial results showed the higher dose of edoxaban to be similar to warfarin for the reduction in the risk of stroke. While warfarin is highly effective in reducing the risk of stroke in patients with atrial fibrillation, it increases the risk of bleeding. Edoxaban demonstrated significantly less major bleeding compared with warfarin.

    Edoxaban for treatment of patients with DVT and PE was studied in 8,292 participants. The study compared the safety and efficacy of edoxaban to warfarin for treating patients with a DVT and/or PE to reduce the rate of recurrence of symptomatic venous thromboembolism (VTE) events (which includes DVT, PE, and VTE-related death). In the trial, 3.2% of participants taking edoxaban had a symptomatic recurrent VTE, compared with 3.5% of those taking warfarin.

    The most common adverse effects observed in trial participants were bleeding and anemia. As with other FDA-approved anticlotting drugs, bleeding, including life-threatening bleeding, is the most serious risk with edoxaban. No treatment has been proven to reverse edoxaban's anticoagulant effect.

    Edoxaban has a boxed warning that provides important dosing and safety information for health professionals about specific patient groups, including a warning that edoxaban is less effective in atrial fibrillation patients with a creatinine clearance greater than 95 mL per minute. This should be assessed before initiating therapy with edoxaban. Patients with creatinine clearance greater than 95 mL per minute have an increased risk of stroke compared with similar patients given warfarin. Edoxaban should not be used in nonvalvular atrial fibrillation patients with a higher creatinine clearance. Another anticoagulant should be used instead.

    As with other anticoagulants, the boxed warning counsels that premature discontinuation of edoxaban increases the risk of stroke and notes that spinal or epidural hematomas may occur in patients treated with edoxaban who are receiving anesthesia injected around the spine or undergoing spinal puncture.

  • February 3, 2015

    FDA has approved first-in-class empagliflozin/linagliptin tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments.

    It is the first and only diabetes treatment in the United States to combine the dual mechanisms of action of a sodium–glucose cotransporter-2 (SGLT-2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet taken in the morning.

    Approval was based on a Phase III clinical trial that evaluated the efficacy and safety of empagliflozin/linagliptin (10/5 mg and 25/5 mg) compared with the individual components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg) in adults with type 2 diabetes who were also taking high-dose metformin (mean dose 1,889 mg daily). The study randomized 686 adults with type 2 diabetes and hemoglobin glycosylated hemogoblin (A1C) between 7.0% and 10.5% to examine the change from baseline in A1C at 24 weeks.

    As an add-on to metformin, empagliflozin/linagliptin showed statistically significant reductions in A1C compared with empagliflozin and linagliptin alone at 24 weeks. Although not approved for lowering weight, the combination drug provided significant weight loss at 24 weeks compared with linagliptin alone.

    Empagliflozin/linagliptin is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

    The most common adverse effects include urinary tract infections, stuffy or runny nose and sore throat, and upper respiratory tract infections.