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New boxed warning on opioids combined with benzodiazepines

The FDA has warned healthcare providers that the growing use of opioids with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious adverse reactions associated with serious risks, including slowed or difficult breathing and death. In an effort to decrease the use of opioids and benzodiazepines or opioids and other CNS depressants together, the agency is adding its strongest warnings (boxed warnings) to drug labeling of prescription opioid pain, prescription opioid cough medications, and benzodiazepines.


The FDA is requiring several changes to reflect these risks in opioid and benzodiazepine labeling and new or revised patient medication guides. These changes include the new boxed warnings and revisions to the warnings and precautions, drug interactions, and patient counseling information sections of the labeling.


The agency is recommending that healthcare professionals limit prescribing opioid pain medications with benzodiazepines or other CNS depressants only to patients for whom alternative treatment options are inadequate. In addition, healthcare providers should avoid prescribing prescription opioid cough medications for patients taking benzodiazepines or other CNS depressants, including alcohol.


If the medications are prescribed together, the FDA advises limiting the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. Furthermore, healthcare providers should warn patients and caregivers about the risks of slowed or difficult breathing and/or sedation, and the associated signs and symptoms.


For a list of all approved prescription opioid pain and cough medications, and benzodiazepines and other CNS depressants, visit


AAP, CDC recommend against using nasal spray flu vaccine

The American Academy of Pediatrics (AAP) issued an updated policy statement indicating that the live attenuated influenza vaccine (LAIV), also known as the nasal spray flu vaccine, is not effective and should not be used in the 2016 to 2017 flu season. The policy statement is in agreement with a recommendation by the CDC in June 2016 not to use LAIV in the upcoming flu season because its effectiveness among children ages 2 to 17 was only 3% during the 2015 to 2016 flu season, compared with 63% for injected vaccines (

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LAIV is marketed as FluMist Quadrivalent. It is currently the only noninjection-based flu vaccine on the market. The CDC noted that data from recent flu seasons suggest that LAIV accounts for about a third of all flu vaccines given to children.


FDA approves Flonase prescription-to-OTC switch

The FDA has approved Flonase Sensimist Allergy Relief (fluticasone furoate 27.5-mcg spray) for nonprescription treatment of symptoms associated with seasonal and perennial allergies. The product was previously available only by prescription as Veramyst. Veramyst and Flonase Sensimist are both products of GlaxoSmithKline.

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Flonase Sensimist is indicated for adults and children age 2 and older for nasal allergy relief and helps block six allergic substances (histamine, prostaglandins, cytokines, tryptases, chemokines, and leukotrienes) to provide 24-hour relief of nasal and ocular allergy symptoms in a nondrowsy formulation. The product is scent- and alcohol-free and will be available nationally in early 2017.