Medication Monitor



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  • December 5, 2012

    The 32-mg single I.V. dose of ondansetron has been pulled from the market, FDA announced yesterday, because of concerns related to cardiac adverse events. In June, the agency warned that the 32-mg dose should be avoided because of the risk of QT interval prolongation, which can lead to torsade de pointes. Preliminary results of a study ordered by the FDA found a maximum mean difference in QTcF of 20 ms after the 32 mg intravenous dose, compared with a QTcF difference of 6 ms for the 8 mg intravenous dose.

    FDA noted that removal of the 32-mg dose should not contribute to a potential ondansetron shortage, as this dose only made up a small percentage of the current market. The agency also noted that it will continue to recommend an I.V. regimen of 0.15 mg/kg administered every 4 hours for three doses to prevent chemotherapy-induced nausea and vomiting. Oral ondansetron was also discussed as an effective alternative for the management of chemotherapy-induced nausea and vomiting.

  • October 5, 2012

    FDA has released an update reporting that Budeprion XL 300 mg is not therapeutically equivalent to GlaxoSmithKline’s Wellbutrin XL 300 mg. This update is based on data from an agency-sponsored study which concluded that Budeprion XL 300 mg tablets failed to release bupropion into the blood at the same rate and to the same extent as the branded product. FDA conducted this study in response to numerous reports that patients who switched from Wellbutrin XL 300 mg to the generic product were experiencing reduced efficacy.

    Based on these data, Impax has requested that the FDA withdraw approval of Budeprion XL 300 mg extended-release tablets and has stopped shipping the product. In addition, it has issued detailed information to patients about this product withdrawal. This update does not apply to the 150-mg dose of Budeprion XL or to the other four generic bupropion extended-release products made by other manufacturers.

    FDA noted that it has not conducted bioequivalence studies of the other four generic versions of Wellbutrin XL 300 mg, but has recently asked each of the other manufacturers—Anchen, Actavis, Watson, and Mylan—to conduct their own studies to assess the bioequivalence of their 300-mg extended-release bupropion tablets to Wellbutrin XL 300 mg. Data from these studies are to be submitted to the agency no later than March 2013.

    Patients taking Budeprion XL 300 mg as a substitute for Wellbutrin XL 300 mg should talk with their health provider if they have questions about taking this medication, the agency advised.

  • September 23, 2011

    As reported earlier this year in Pharmacy TodayPrimatene Mist, the only FDA-approved OTC inhaler for temporary relief of occasional symptoms of mild asthma on the U.S. market, is being withdrawn after December 31 of this year. 

    FDA is concerned that current users of the product may be self-treating their conditions. Since all other currently available products for asthma require a prescription, Primatene Mist users need to act now to see a prescriber and obtain the medications they need. In addition, the agency is concerned that many of these patients are likely uninsured and may have financial difficulties in seeing a prescriber and paying for prescription products.

    Primatene Mist uses chlorofluorocarbon (CFC) as its propellant, and the U.S. is phasing out CFC use because of obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. The phaseout of CFC-containing inhalers was announced by FDA in 2008, and many manufacturers of prescription inhalers have already converted their propellants to environmentally friendly hydrofluoroalkane (HFA).

    FDA said during a September 22 news conference that two prescription inhalers will be withdrawn from the market on December 31, 2013, if they are not reformulated with HFA or another acceptable propellant. They are Combivent Inhalation Aerosol (albuterol/ipratropium—Boehringer Ingelheim) and Maxair Autohaler (pirbuterol—Graceway Pharmaceuticals).

    Pharmacists should advise patients currently using OTC inhalers to contact their health provider to have symptoms evaluated and obtain prescription asthma medications if needed. FDA has provided several helpful counseling tips for patients currently using OTC epinephrine inhalers. These include telling patients to ask a family member, friend, or co-worker about a doctor they use and would recommend, helping patients with payment options and company assistance plans, and educating patients on use of their new prescription inhalers once they are transitioned to these products. The last point is especially important, an FDA official said, as the replacement products may taste and feel different.

  • October 27, 2011

    In today's MMWR, CDC announced that on November 30 it will stop providing the investigational pentavalent (ABCDE) botulinum toxoid (PBT) for vaccination to workers at risk for occupational exposure to botulinum serotypes. The agency cited evidence of declining immunogenicity, decreased product potency, increased occurrence of injection site-related adverse reactions, and the age of the product in explaining its decision. For recent vaccinees who need to complete the primary series, the investigational new drug application will remain in effect through May 31, 2012.

    CDC summarized data showing that protective antibody levels against all toxin serotypes decline rapidly and that revaccination was required at 6 months, after the initial primary series of 0, 2, and 12 weeks, and that an annual booster was also needed to obtain adequate protection. Those data prompted a change in the initial primary series in 2004 to include vaccinations at 0, 2, and 12 weeks, and 6 months as the the new primary series with a required annual booster to acheive a robust enough immune response.

    As a result of this modified schedule, moderate local skin reactions rose from 12.4% in 2005 to 31.0% by 2010. No increase in severe local reactions was observed.

    Once this investigational product is discontinued, no replacement botulism vaccine will be available in the U.S. A recombinant botulism vaccine is being developed by the Department of Defense Chemical Biological Medical Systems Joint Project Management Office.

  • October 25, 2011

    Drotrecogin alfa (activated) is being withdrawn from worldwide markets following release of results of the PROWESS-SHOCK study, which showed that use of the drug did not result in a statistically significant reduction in 28-day all-cause mortality in patients with septic shock, according to a Lilly news release. Timothy Garnett, MD, Lilly's Senior Vice President and Chief Medical Officer, stated in the release, “While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit–risk profile of Xigris and its continued use. Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients."

    Drotrecogin alfa was originally approved in the United States in November 2001 for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (e.g., as determined by APACHE II). Heath providers with questions about the removal of drotrecogin alfa from the market are directed to contact the Lilly Answer Center at 800-LillyRx or visit the company online. In the United States and Puerto Rico, BioCritica, Inc. has had sales and marketing rights for Xigris.

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