Medication Monitor

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  • August 18, 2011

    McNeil Consumer Healthcare announced that it is recalling, at the retail and wholesaler levels only, certain lots Tylenol Cold Multi-Symptom Nighttime Rapid Release Gels and Tylenol Cold Multi-Symptom Rapid Release Gels Day/Night. Lots were distributed in the United States and Puerto Rico. Some products may contain higher-than-expected levels of  (CPAA), the company said.

    McNeil noted that no safety concerns have been associated with CPAA, a compound that forms normally from two product ingredients. It is unlikely to cause adverse reactions. Patients who have the product can continue to use it. A specific list of product lot numbers and UPC codes can be accessed on the website.

  • August 16, 2011

    As part of the requirements of the Risk Evaluation and Mitigation Strategy (REMS) program for ticagrelor, AstraZeneca sent a letter to health providers and professional organizations informing them of increased bleeding risks with this new antiplatelet agent. A copy of the full prescribing information and Medication Guide were also included with the letter.

    Within the letter, the increased risk for bleeding and a unique warning about appropriate aspirin dosing were communicated. According to the warning, maintenance doses of aspirin exceeding 100 mg/d reduce the effectiveness of ticagrelor and should be avoided. Counseling points for patients and the process for reporting adverse drug events were also included in the letter.

    Ticagrelor is approved to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome, including those with unstable angina, non-ST elevation myocardial infarction (NSTEMI), and STEMI.

  • August 9, 2011

    FDA released an update to its December 2010 safety communication  regarding a possibly increased mortality risk associated with use of somatropin, recombinant human growth hormone. After reviewing results from the SAGhE (Santé Adulte GH Enfant) study and other available information from the published literature and the agency's Adverse Event Reporting System, FDA determined that the evidence supporting an increased risk of death with this product is inconclusive.

    The agency said it will continue to review this safety issue and expects to receive additional SAGhE data in spring 2012.

  • August 5, 2011

    A nationwide voluntary recall 17 different lots of vasopressin injection has been issued by American Regent because of concerns that some drug vials may not maintain their potency throughout their self-life resulting in reduced effectiveness. Products affected include 5 lots of Vasopressin Injection, 20 units/mL (200 units/10mL), 10 mL Multiple Dose Vials (NDC # 0517-0410-10); 11 lots of Vasopressin Injection, 20 units/mL, 1 mL Multiple Dose Vials (NDC # 0517-1020-25); and 1 lot of Vasopressin Injection, 10 units/0.5 mL, 0.5 mL Multiple Dose Vials (NDC # 0517-0510-25).

    The lots are being recalled for the time period of January 1, 2009 to July 27, 2011. When the recall was announced, American Regent had received no reports of adverse events related to reduced effectiveness of vasopressin injection. These products were distributed to wholesalers and distributors nationwide.

  • August 5, 2011

    FDA has approved updated labeling for all pioglitazone-containing products to include new safety information about the risk of bladder cancer when these products are used for more than 1 year. This action comes after numerous safety alerts released by FDA in recent months regarding this risk. Specific recommendations include not using pioglitazone in patients with active bladder cancer and using the drug cautiously in those with a prior history of bladder cancer.

    In addition, patients on pioglitazone should be counseled to contact their health provider if they experience any signs of potential bladder cancer: blood in urine, worsening urinary urgency, or pain on urination.