Medication Monitor



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  • July 11, 2011

     

    The concentration of oseltamivir suspension will be changed from 12 mg/mL to 6 mg/mL, FDA has announced. This lower concentration is less likely to become frothy when shaken and will help with accurate measurements of the liquid, the agency said. Additional changes include the measurements on the oral dosing device, which will be switched from mg to mL; a change in the dosing table to include a column for dosing (mL) based on this new concentration; revised container and carton packaging; and compounding instructions for preparation of a 6 mg/mL oral suspension in emergency situations when the commercially marketed product is unavailable. 

     

    The 12 mg/mL concentration will no longer be marketed once the current supply runs out, and Genentech has instituted a voluntary Take Back Program for wholesalers, distributors, and pharmacies to remove product of the older concentration from the market. FDA notes that both concentrations may be available in the pharmacy for the 2011-12 influenza season, and health providers must be aware of this issue and to take steps to avoid medication errors as a result of confusion between the two concentrations.

  • July 8, 2011

     

    A National Safety Alert for Serious Medications Errors has been released by the American Society of Heath-System Pharmacists (ASHP) and the Institute for Safe Medication Practices (ISMP) regarding misdosing of the antibiotic colistimethate, resulting in fatal errors. Colistimethate is a prodrug that is converted to an active moiety in the body.  In the U.S., all FDA-approved labeling and dosing information is in terms of the base drug colistin, not the prodrug. The problem has been that some Internet sources and journal references give dosing information based on the prodrug (colistimethate), resulting in overdoses if the prodrug dose is confused with the colistin dose.

    In a recent case, a physician mistakenly ordered a dose of colistimethate as the prodrug, but the amount was dispensed as the colistin base. The patient received this high dose and developed acute renal failure and later died. The alerts gives recommendations on steps to prevent misdosing of colistimethate, including developing dosing limits, restricting prescribing to infectious disease specialists, and monitoring patient’s renal function.

  • July 1, 2011

    In late June, FDA’s Oncologic Drugs Advisory Committee voted unanimously that FDA withdraw its approval of bevacizumab for use in metastatic breast cancer. Bevacizumab is currently approved for use in combination with paclitaxel chemotherapy for previously untreated HER2-negative metastatic breast cancer. A review of data from 5 randomized clinical trials with more than 3,500 patients showed that none of these trials demonstrated a significant improvement in overall survival or quality of life. In addition, none of these subsequent studies confirmed the magnitude of benefit seen in the original trial (E2100 trial), which provided the evidence for accelerated approval of bevacizumab for metastatic breast cancer in 2008.

    Given the risks of bevacizumab, such as intestinal perforation and hemorrhage, the committee concluded that bevacizumab has not been shown to present a clinical benefit that justifies the risks associated with use of the product for this indication and that it should not remain approved while Genentech designs and conducts additional studies to verify the drug's benefit. The FDA Commissioner will make a final decision on whether bevacizumab should remain approved for metastatic breast cancer.   

  • June 30, 2011

    FDA has released a safety communication warning of cognitive delay in children whose mothers used valproate, valproic acid, or divalproex sodium during pregnancy. Evidence from epidemiologic studies showed that children exposed to valproate in utero tended to score lower on cognitive tests, compared with children exposed to other antiepileptic drugs (AEDs) or no AEDs, at age 3 and ages 5 to 16. The long-term effects on cognitive development from exposure to these agents are currently unknown and the effects in offspring with only limited exposure to these agents in utero, such as during the first trimester only, is also unknown. Information about the risk of lower cognitive test scores will be added to the labeling of these products and to the Medication Guides. FDA recommended that when feasible, "alternative medications that have a lower risk to the fetus of birth defects and adverse cognitive effects should be considered in pregnant women and women of childbearing age. If the decision is made to use valproate in women of childbearing age, effective birth control should be used.” 

  • June 28, 2011

    McNeil Consumer Healthcare has initiated a voluntary recall at the retail level of a single lot (#ABA619) of Tylenol (acetaminophen) Extra Strength Caplets, 225 count bottles, UPC code 300450444271. This recall was initiated because of a small number of musty, moldy odor reports that has been linked to trace amounts of 2,4,6-tribromoanisole (TBA). The risks of serious adverse events with TBA are remote, but exposure may be associated with mild gastrointestinal symptoms in some patients. This product was manufactured in February 2009, and 60,912 bottles were distributed in the United States. Consumers who purchased this product should be told to contact the manufacturer for a refund or product coupon.    

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