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    Drotrecogin alfa (activated) is being withdrawn from worldwide markets following release of results of the PROWESS-SHOCK study, which showed that use of the drug did not result in a statistically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

  • January 5, 2016

    FDA is advising consumers not to purchase or use the following products promoted and used for sexual enhancement on various websites and in some retail stores because they contain undeclared ingredients that may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

    Rhino Big Horn 3000 contains desmethyl carbodenafil and sildenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, a prescription drug for erectile dysfunction (ED). 

    Rhino 7 Blue 9000 contains tadalafil, the active ingredient in the prescription drug Cialis, used to treat ED.

    OrgaZen 3500 contains tadalafil. 

    OrgaZen 3000 contains tadalafil. 
    Eros Power Zone 1900 contains desmethyl carbodenafil and dapoxetine. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

    Triple MiracleZen Plus 1500 mg contains sildenafil, tadalafil, and dapoxetine. Sildenafil and tadalafil are the active ingredients in Viagra and Cialis, respectively. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

    Triple MiracleZen Gold 1750 mg contains sildenafil, tadalafil, and dapoxetine.

    Triple MiracleZen Extreme 1750 mg contains sildenafil, tadalafil, and dapoxetine. 

    Diamond 3500 contains sildenafil and tadalafil.

    Xtra Zone 2600, contains sildenafil and tadalafil.

    Xtra Zone 2400 contains sildenafil and tadalafil. 

    Triple Power Zen Plus 2000 contains sildenafil and tadalafil.

    Triple Power Zen Gold 2000 contains sildenafil and tadalafil.

  • March 26, 2018

    Biogen and AbbVie are voluntarily withdrawing daclizumab, a multiple sclerosis (MS) drug, from the global market, noting concern about the drug’s evolving benefit/risk profile.

    FDA announced it is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States and to ensure that health professionals have the information they need to carefully transition their patients using daclizumab to another treatment. No new patients will start taking daclizumab or participate in clinical studies.

    The company has begun notifying health professionals and patients, and the drug will be available for patients as needed until April 30, 2018.

    Patients using daclizumab should not stop their medication without talking with their doctor and should contact their doctor immediately if they have any new and unexplained symptoms. Any questions or concerns about the withdrawal can be directed to the manufacturers’ service center at 800-456-2255 or the manufacturer’s website at www.zinbryta.comdisclaimer icon. FDA stated that it understands that this may be a difficult situation for some patients and will continue to work closely with the manufacturers throughout the withdrawal process.

    The complex safety profile of daclizumab has been recognized since the time of FDA approval. The drug’s safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more MS drugs, to a boxed warning about the risk of liver injury and of other immune-mediated disorders, and to a Risk Evaluation and Mitigation Strategy making the drug available only through a restricted distribution program.

    FDA has continuously monitored adverse events associated with use of daclizumab and has updated product labeling as new information became available.

    Recently, the European Medicines Agency announced a recall of daclizumab following 12 reports of serious inflammatory brain disorders worldwide. FDA is aware of these reports and is conducting a review of similar events. As the manufacturers move forward the withdrawal plan, any additional important information will be made available to the public. 

    FDA asks health professionals and consumers to report any adverse reactions or quality problems to FDA’s MedWatch program at

  • November 20, 2015

    FDA has approved naloxone hydrochloride as a nasal spray under the trade name Narcan. It is the first FDA-approved nasal spray version of naloxone, a life-saving medication that can stop or reverse the effects of an opioid overdose.

    Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.

    Narcan nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This prescription product can be used on adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

    However, it is important to note that it is not a substitute for immediate medical care, and the person administering Narcan nasal spray should seek further immediate medical attention on the patient’s behalf.

    The FDA granted fast-track designation and priority review for Narcan nasal spray. Narcan is being approved in less than 4 months, significantly ahead of the product’s prescription drug user fee goal date of January 20, 2016.

    In clinical trials conducted to support the approval of Narcan nasal spray, administering the drug in one nostril delivered approximately the same levels or higher of naloxone as a single dose of an FDA-approved naloxone intramuscular injection, and achieved these levels in approximately the same time frame.

    The National Institute on Drug Abuse (NIDA) played a critical role in the development of Narcan nasal spray as well, forming a public–private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. NIDA then worked with its private sector partners to obtain FDA approval.

    Use of Narcan nasal spray in patients who are opioid dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.