Handheld hematoma scanner, new indication for pneumonia vaccine approved

Details on new approvals and more.

Recalls and warnings

An advisory and recall related to potential mix-ups of some prescription opiate medications and over-the-counter non-opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health. A stray pill of one medication may have ended up in the bottle of another product. The FDA advises patients and healthcare professionals to examine opiate medicines made by Endo and ensure that all tablets are the same. The agency also expects shortages for these products and is working with the manufacturer to minimize the impact. Recalled products include Excedrin, NoDoz, Bufferin and Gas-X.

Photo by Thinkstock
Photo by Thinkstock.

A label revision on dronedarone (Multaq) based on a review showing that it increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The drug should not be prescribed to patients with permanent AF, and patients who do receive the drug should receive appropriate antithrombotic therapy and an electrocardiogram at least once every three months. Dronedarone is indicated to reduce hospitalization for patients with paroxysmal or persistent AF.

A recall of certain lots of Motrin IB from retailers after product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.

A Class I recall of Riata and Riata ST Silicone Defibrillation Leads due to externalized conductors. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur. No blanket recommendation has been made regarding patients who have these leads, so physicians may choose to individualize the approach to management based on individual patient characteristics.

A Class I recall of Ikaria INOmax DS Drug Delivery systems because erratic nitric oxide monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals. Adverse consequences may include inadequate hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome, neurological deficits or death.

A recall of Bivona Neonatal, Pediatric and Flextend tracheostomy tubes because some customers have experienced difficulty disconnecting accessories from the connectors of the affected tubes, which in some cases led to the need for an emergency tracheostomy tube change.

A revision of a previous change to the dose limitation for simvastatin when it is co-administered with amiodarone. In June 2011, the FDA recommended that the maximum dose for simvastatin taken with amiodarone be decreased from 20 mg to 10 mg. The agency now says that change was made in error and that the dose limitation should be 20 mg. Drug labels for simvastatin products (Zocor, Vytorin) have been updated to reflect this correction.


The Infrascanner Model 1000, the first handheld device intended to aid in the detection of intracranial hematomas. The device uses a scanner that directs near-infrared light into the skull and then detects differences in optical density and transmits the information wirelessly to a display on a handheld computer. Approval was based on a comparison with 383 CT scans in which the new scanner found nearly 75% of hematomas detected by CT and found no hematoma in 82% negative CT scan patients. The scanner is not a substitute for a CT, the FDA noted.

A new indication for a pneumococcal 13-valent conjugate vaccine (Prevnar 13) to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae in people ages 50 years and older. The vaccine was already approved for use in children ages 6 weeks through 5 years. In trials of patients 50 and over, it induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

A new indication for raltegravir (Isentress) for use with other antiretroviral drugs to treat HIV-1 infection in children and adolescents ages 2 to 18. It was approved for adults in October 2007 and the new indication is based on a single, multi-center clinical trial of 96 children and adolescents in which after 24 weeks of treatment, 53% had an undetectable amount of HIV in their blood. The most common side effects were insomnia and headache.