Medication Monitor



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  • October 24, 2011

    Jet injector devices should not be used to administer influenza vaccines, according to a FDA communication. Approved influenza vaccines are not labeled to be used with a jet injector. The only vaccine currently approved for administration by jet injector is the measles, mumps, and rubella (MMR) vaccine.

    According to the agency, influenza vaccines are only approved for administration by needle injection or nasal mist sprayer. The injectable influenza vaccines should be administered via the intramuscular, subcutaneous, or intradermal routes in accordance with their labeling using a needle and syringe unless otherwise specified.

    The influenza vaccines have not been evaluated for delivery by jet injection and this method of administration represents a different method of delivery that has the potential to change the characteristics of an approved vaccine. The agency recommends that all approved vaccines, including influenza, be administered in accordance with their labeling and that health care professionals carefully review the Dosage and Administration section of approved vaccine labeling and the product labeling on injector devices prior to any vaccine administration.

  • October 21, 2011

    Additional information regarding the interaction between methylene blue and serotonergic psychiatric medications has been released by FDA. The agency noted that most cases of serotonin syndrome in its Adverse Event Reporting System (AERS) involved patients who were on serotonergic psychiatric medications when they received intravenous methylene blue in doses of 1–8 mg/kg as a visualizing agent during parathyroid surgery. Selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, or clomipramine were generally involved when the serotonin syndrome occurred.

    The agency also noted that it not known whether this risk persists in patients taking serotonergic psychiatric medications who are given methylene blue, an unapproved drug, by other routes (e.g., orally or by local tissue injection) or at intravenous doses lower than 1 mg/kg. The safety update lists serotonergic psychiatric drugs implicated in the AERS cases of serotonin syndrome with methylene blue and other psychiatric drugs with varying degrees of serotonergic activity for which the risk of serotonin syndrome with methylene blue is unclear.

  • October 21, 2011

    Additional information regarding the interaction between linezolid and serotonergic psychiatric medications has been released by FDA. Most cases of serotonin syndrome with linezolid in the Adverse Event Reporting System (AERS) occurred in patients taking selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors, FDA said.

    The risk with other psychiatric drugs with lesser degrees of serotonergic activity is not clear. The safety update lists serotonergic psychiatric drugs implicated in the AERS cases of serotonin syndrome with linezolid and other psychiatric drugs with varying degrees of serotonergic activity for which the risk of serotonin syndrome with linezolid is unclear.

  • October 21, 2011

    A single lot of Nostrilla Nasal Decongestant nasal spray (Lot #11G075, UPC Code 6373673005) is being recalled to the consumer level because it may contain the bacteria Burkholderia cepacia, according to FDA. The recall was initiated following internal investigations that determined the potential presence of a microbial contaminant exceeding the product specifications. Burkholderia cepacia may cause serious infection in immunocompromised patients or those with chronic lung conditions. The chances of an infection in healthy patients is minimal.

    The product was distributed nationwide to retail stores and pharmacies. It is packaged in 0.5-ounce plastic bottles with an expiration date of 05/2014 stamped on the side.

    No illnesses have been reported to date in connection with this problem. Patients who purchased the product are urged to return it and contact the company at 877-546-9059.

  • October 11, 2011

    Dasatinib may increase the risk of of pulmonary arterial hypertension (PAH), according to a safety alert released by FDA today. Since the drug's approval in June 2006, a total of 12 cases of PAH have been identified through the manufacturer’s global pharmacovigilance program and confirmed using right heart catheterization. Patients developed PAH after taking dasatinib for various amounts of time, including use for more than 1 year. No fatalities from the condition have been reported, and in some cases, improvements in hemodynamic and clinical parameters were observed following discontinuation of dasatinib.

    Information about this risk has been added to the Warnings and Precautions section of the labeling. According to the agency, health care providers should evaluate patients for signs and symptoms of underlying cardiopulmonary disease before starting dasatinib and during treatment. If PAH is confirmed, the drug should be permanently discontinued. In addition, patients should be educated on the symptoms of PAH: shortness of breath, fatigue, and swelling of the ankles and legs. Patients who develop these symptoms should notify their health care professional immediately.

    Dasatinib is indicated for the treatment of adults with Philadelphia chromosome–positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy, for the treatment of adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase, and for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Philadelphia chromosome-positive CML with resistance or intolerance to prior therapy.

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