Rivaroxaban approved, warning issued on pioglitazone

Details on approval of rivaroxaban, a warning about pioglitazone and bladder cancer, and more.


Recalls and warnings

A warning on pioglitazone (Actos) about the medication's possible association with bladder cancer. The FDA recommends that clinicians not use pioglitazone in patients with active bladder cancer and use it cautiously, weighing risks and benefits, in patients with a prior history of bladder cancer.

Photo by Comstock
Photo by Comstock.

A recall of one lot of indomethacin for injection, 1 mg single-dose vials, as it may contain particulates of the drug, which may provoke an immune reaction and/or lead to microinfarcts that could be serious and life-threatening.

A recall of one lot of risperidone (Risperdal) 3-mg tablets and one lot of risperidone 2-mg tablets stemming from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2, 4, 6-tribromoanisole (TBA) used in pallets for transporting the drug.

A warning added to varenicline (Chantix) about a possible small increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. Clinicians should weigh the known benefits of the drug against potential risks when deciding whether to use it in smokers with cardiovascular disease.

A change in dosing guidelines for erythropoiesis-stimulating agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD), because of the increased risks of cardiovascular events. Until now, product labels for ESAs recommended dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL in patients with CKD. The modified package insert removes the concept of a target hemoglobin range.

A recall of specific lots of butalbital, acetaminophen, and caffeine tablets (USP 50 mg, 325 mg, 40 mg) and hydrocodone bitartrate and acetaminophen tablets (USP 7.5 mg, 500 mg) by Qualitest because the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone. Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea and patients with an allergy to butalbital could experience a hypersensitivity reaction.

A recall of oxycodone/acetaminophen tablets (Endocet) because some bottles may contain different strength tablets, which could result in larger than intended acetaminophen doses, potentially leading to liver toxicity.

A recall of calcium gluconate injection from American Regent because some vials may contain silicone particles. Potential adverse events include disruption of blood flow within small blood vessels in the lung, localized inflammation and granuloma formation.

A recall of one lot of Tylenol extra strength caplets, 225-count bottles, due to reports of an uncharacteristic odor thought to be TBA.

A new warning on valproate sodium and related products (valproic acid and divalproex sodium) that taking the drug during pregnancy may increase children's risk of lower cognitive test scores compared to children exposed to other anti-seizure medications. The FDA warned the public in December 2009 about the risk of neural tube birth defects after exposure to valproate products during pregnancy.

Approvals

Rivaroxaban (Xarelto), a once-daily pill to reduce the risk of venous thromboembolic events (VTE) following knee or hip replacement surgery. In trials of more than 6,000 patients, 9.7% of patients undergoing knee replacement who took rivaroxaban had VTE compared with 18.8% of patients who received enoxaparin. In a hip replacement study, 1.1% of the rivaroxaban group had VTE compared with 3.9% of those on enoxaparin. Patients undergoing a knee replacement should take the medication for 12 days and patients undergoing a hip replacement procedure should take it for 35 days.

Influenza vaccines for the 2011-2012 season, containing three strains: A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus), A/Perth /16/2009 (H3N2)-like virus and B/Brisbane/60/2008-like virus.

The first generic versions of levofloxacin (Levaquin), to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate and certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.