FDA Actions
FDA Actions
The FDA is requiring a boxed warning on sodium phosphate bowel-cleansing products because of the risk of acute phosphate nephropathy associated with use of these products. Sodium phosphate cleansing products are most commonly used as bowel preparation for procedures such as colonoscopy. According to the warning, the products Visicol® and OsmoPrep® should be used with caution in people older than age 55; those suffering from dehydration, kidney disease, colitis, or delayed bowel emptying; and people taking other medications that may affect kidney function. These products should also not be used in conjunction with other oral laxatives containing sodium phosphate, and over-the-counter products, such as Fleet® Phospho-Soda®, should also be used with caution if given in a high dose to the patient population at risk.
The FDA is requiring a warning on all anti-epileptic drugs regarding the risk of suicidal thoughts and behavior. The warning is based on review of nearly 200 studies that showed that patients on anti-epileptic drugs were at almost twice the risk of suicidal behavior or thoughts compared to patients on placebo. Along with the warning, the agency is also requiring a Medication Guide for patients as part of its Risk Evaluation and Mitigation Strategy. Over 20 drugs will be required to change their labeling including the commonly used agents phenytoin, carbamazepine, divalproex, gabapentin, lamotrigine, primidone, and topiramate.
The FDA is considering a ban on the long-acting beta agonists salmeterol (Serevent®) and formoterol (Foradil®) for the treatment of asthma. An expert committee comprised of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee voted unanimously to withdraw the indication for the treatment of asthma for the two drugs based on evidence from meta-analyses showing increased risk of death associated with use of long-acting beta agonist when not paired with a steroid inhaler. The committee did not vote to ban Advair® or Symbicort®, inhalers that combine a long-acting beta agonist with a steroid. If the FDA follows the subcommittee's recommendations, the drugs would no longer be indicated for treatment of asthma but would remain on the market to treat chronic obstructive pulmonary disorders. The FDA has not indicated when it will act on the subcommittee's recommendations.
The FDA has approved fenofibric acid (Trilipix™) for use with a statin for the treatment of dyslipidemia. This is the first fibrate approved for use with statins. The approval is based on a large trial in which the drug was used in combination with rosuvastatin (Crestor®), atorvastatin (Lipitor®), and simvastatin (Zocor®). There have been safety concerns about using fibrates and statins together, particularly gemfibrozil, but the newer generation fibrates appear safer. Abbott, the manufacturer of Trilipix, is collaborating with AstraZeneca to develop a fenofibric acid/rosuvastatin fixed combination product within the next year.