New pneumonia vaccine option for patients over 50

Recalls, warnings, approvals and other regulatory news.

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 health care 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.


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 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.

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 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, multicenter 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.

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% of negative CT scan patients. The scanner is not a substitute for CT, the FDA noted.


The risk that taking selective serotonin reuptake inhibitor antidepressants during pregnancy will lead to persistent pulmonary hypertension of the newborn is still unclear, according to an FDA update. The agency originally advised the public about this risk in July 2006 based on a single study, and since then findings have been conflicting. At this time, the agency advises health care professionals not to alter their current clinical practice of treating depression during pregnancy.

The FDA is evaluating a post-marketing report that one patient with multiple sclerosis died within 24 hours of taking the first dose of fingolimod (Gilenya). At this time, it has not been determined whether the drug resulted in the patient's death; the FDA has said that the drug provides an important health benefit when used as directed and recommends that prescribers follow the recommendations of the approved drug label.

An additional concentration of liquid acetaminophen marketed for infants (160 mg/5 mL) is now available. Until now, liquid acetaminophen marketed for infants was only available in 80 mg/0.8 mL or 80 mg/mL concentrations. This change in the concentration will affect the amount of liquid given to an infant, and to avoid confusion, clinicians should provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given.

A single, shared-system Risk Evaluation and Mitigation Strategy (REMS) has been approved for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medications. Prescribers of TIRF medications for outpatient use are required to enroll in the TIRF REMS Access program, although those who are already enrolled in an individual REMS program for at least one TIRF medicine will be automatically transitioned. In outpatient settings, all prescribers must complete and sign a TIRF REMS Access Patient-Prescriber Agreement Form with each new patient before writing the patient's first TIRF prescription. Clinicians who prescribe the medications for inpatient use only are not required to enroll. The TIRF REMS Access program is the first approved class REMS for drugs in the opioid class, and the FDA is continuing work on another class REMS for long-acting and extended-release opioids.