New dosing for ESAs and oseltamivir, warning on pioglitazone

Recalls, warnings, and approvals.

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 history of bladder cancer.


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.


Rivaroxaban (Xarelto), a once-daily pill to reduce the risk of venous thromboembolic events (VTEs) 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.

Belatacept (Nulojix), a selective T-cell costimulation blocker, to prevent acute rejection in adult patients who have a kidney transplant. The drug is approved for use with other immunosuppressants and carries a boxed warning for an increased risk of developing post-transplant lymphoproliferative disorder.

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.


The FDA released a report highlighting the risks of silicone gel-filled breast implants. While the implants are safe and effective when used as intended, women should know that one in five patients who received implants for breast augmentation will need them removed within 10 years of implantation, the FDA said. The agency recommends that women who have silicone gel-filled breast implants routinely follow up with their health care professionals and get routine MRIs to detect silent rupture.

The concentration of oseltamivir phosphate (Tamiflu) oral suspension has been reduced, and labels and dosing have changed accordingly, the FDA announced. The concentration was been reduced from 12 mg/mL to 6 mg/mL, because the lower concentration is less likely to become frothy when shaken, which helps to ensure an accurate measurement, according to the FDA. The oral dosing device provided with the medication has also been changed to use milliliters instead of milligrams.