Medication Monitor

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  • 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    Drotrecogin alfa (activated) is being withdrawn from worldwide markets following release of results of the PROWESS-SHOCK study, which showed that use of the drug did not result in a statistically significant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.

  • 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.

  • July 19, 2011

    Amylin announced that it will stop manufacturing Symlin vials, but will continue to market the SymlinPen pen-injector delivery system. Pharmacists are advised to continue dispensing the existing stock of the vials until inventories have been depleted, and health providers are advised to start transitioning patients over to the pens. It is important to note that when switching patients from the vial to the pen, doses will need to be converted from units to mcg as follows: 2.5 units = 15 mcg, 5 units = 30 mcg, 7.5 units = 45 mcg, 10 units = 60 mcg, and 20 units = 120 mcg.

  • May 1, 2011

    Teva has voluntarily withdrawn its lansoprazole delayed-release orally disintegrating tablets (ODT) after FDA received reports that the tablets clogged and blocked oral syringes and feeding tubes, including gastric and jejunostomy tubes. The ODT tablets reportedly do not fully disintegrate fully when water is added or disintegrate and later form clumps that clog oral syringes and feeding tubes.