echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > False propaganda can be fatal! FDA warning

    False propaganda can be fatal! FDA warning

    • Last Update: 2019-12-13
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    On December 2, the U.S Food and Drug Administration (FDA) sent a warning letter to arkermes, Massachusetts Today, the FDA issued a notice and released the specific content of the warning letter, saying that the company missed the warning of the most serious risks related to the drug in the publicity materials, thus misleading the use of vivitrol (a sustained-release injection of naltrexone) Vivitrol has been approved to prevent the recurrence of opioid dependence It is well known that drug-assisted therapy, the use of drugs like vivitrol, combined with counseling and behavior therapy, is effective in the treatment of opioid use disorder (oud), which can help some people maintain recovery Thomas Abrams, director of the FDA prescription drug promotion office of the FDA drug evaluation and Research Center, said in the announcement: "one way for FDA to protect public health is to ensure that the prescription drug information disseminated by drug sponsors is true, balanced and accurate We do this by reviewing prescription drug advertisements and publicity labels to ensure that the information contained in these publicity materials is not false or misleading, and vivitrol's promotion method does not fully display important risk information in a true and non misleading way From a public health point of view, this is worrying, because in this vulnerable group of patients, there may be fatal opioid overdoses " The following is the specific content of the warning letter: Dear Mr pops: the office of prescription drug promotion (opdp) of the U.S Food and Drug Administration (FDA) has reviewed a print advertisement (print ad) (viv-003460-v2) for vitrol (naltrexone for extended release injectable suspension) for internal use (vital) submitted by Alkermes, Inc (Alkermes) under cover of Form FDA 2253 The print ad is false or misleading because it omits important risk information associated with the use of Vivitrol Thus, the print ad misbrands Vivitrol within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative 21 U.S.C 352(n); 321(n); 331(a).  See 21 CFR 202.1(e)(5).  This violation is concerning from a public health perspective because it creates a misleading impression regarding the overall safety of  Vivitrol.  Opioid dependence and misuse is a significant public health concern and a national crisis that impacts millions of lives in the United States.  When used as provided in the FDA
    approved product labeling, Vivitrol is safe and effective for the prevention of relapse to opioid dependence, following opioid detoxification. However, those utilizing Vivitrol for the treatment of opioid dependence should be made aware of the vulnerability to potentially fatal overdose at the end of a dosing interval, After missing a dose, or after discontinuing vivitrol treatment Attempts to achieve blockade may also lead to fatal overdose Printed advertising has false or misleading information because it ignores important risk information related to the use of vivitrol As a result, he printed the wrong advertisement of vivitrol within the scope of FD & C law and made its sales illegal From a public health point of view, this violation is worrisome because it gives a misleading impression of the overall safety of vivitrol Opioid dependence and abuse is a major public health problem and a national crisis affecting the lives of millions of people in the United States When used in FDA approved product labeling, vivitrol is safe and effective in preventing relapse of opioid dependence and opioid detoxification However, those who use vivitrol to treat opioid dependence should be aware of the potential risks at the end of the dosing interval, after missed administration, or after discontinuation of vivitrol treatment Attempts to overcome dependence can also lead to fatal overdoses Background below is the indication and the summary of the most serious and most common risks associated with the use of vivitrol (this information is for background purposes only and does not necessarily represent risk information that should be included in the promotional products described in this letter.) Treatment with vitamin should be part of a comprehensive management program that includes psychosocial support Vitamin is indicated for the treatment of alcohol dependence in patients who are able to remain from alcohol in an outpatient setting Prior to initiation of treatment with videtrol Patients should not be actively driving at the time of initial videtrol administration Videtrol is indicated for the prevention of relapse to opioid dependency, following opioid distraction Vivitrol is suitable for alcohol dependent patients who abstain from alcohol in the clinic before starting treatment with vivitrol Patients should not take the initiative to drink when using vivitrol for the first time It can prevent the relapse of opioid dependence after the treatment of opioid drugs Vivitrol is contraindicated in patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent.  The PI for Vivitrol includes warnings and precautions regarding vulnerability to opioid overdose, injection site reactions, precipitation of opioid withdrawal, hepatotoxicity, depression and suicidality, when reversal of Vivitrol blockade is required for pain management, eosinophilic pneumonia, hypersensitivity reactions including anaphylaxis, intramuscular injections, alcohol withdrawal, and interference with laboratory tests.  The most common adverse reactions observed with Vivitrol therapy in opioid-dependent patients were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, Patients receiving opioid analgesics, current physiological opioid dependence, acute opioid withdrawal, failure of naloxone provocation test or positive opioid urinalysis test, and patients previously allergic to naltrexone are not allowed to use vivitrol, PLG, carboxymethylcellulose or any other components of diluent Vivitrol's PI includes preventive measures to warn and prevent opioid overdose, injection site reaction, opioid precipitation, hepatotoxicity, depression and suicide When vitamin blockers are needed to reverse pain, eosinophilic pneumonia and anaphylaxis include anaphylaxis, intramuscular injection, alcohol withdrawal and laboratory examination interference The most common side effects of vivitrol in the treatment of opioid dependent patients are liver enzyme abnormality, injection site pain, nasopharyngitis, insomnia and toothache False or misleading risk presentation: promotional materials misbrand a drug if they are false or misreading with respect to risk The determination of which promotional materials are misreading includes, along other things, not only representations made or suggested in promotional materials, but also failure to If the propaganda material is false or misleading in the side effects, the propaganda material will give the wrong expression to the drug Determine whether the promotional material is misleading, including statements made or recommended in the promotional material, and the possible consequences of failure to use the drug as recommended or recommended in the statements or materials The print ad contains claims and representations about the benefits of Vivitrol.  However, the print ad fails to communicate information from the WARNINGS AND PRECAUTIONS section of the PI concerning vulnerability to opioid overdose, a potentially fatal risk Specifically, the PI states that after opioid detoxification, patients are likely to have reduced tolerance to opioids.  Vivitrol blocks the effects of exogenous opioids for approximately 28 days after administration.  However, as the blockade wanes and eventually dissipates completely, patients who have been treated with Vivitrol may respond to lower doses of opioids than previously used, just as they would have shortly after completing detoxification This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment Furthermore, There is also the possibility that a patient who is treated with vivitrol could come over the opioid blockade effect of vivitrol Patients should be told of the series sequences of trying to come over the opioid blockade However, the print ads failed to convey some of the warning and prevention messages from the PI about opioid overdose, a potentially fatal risk Specifically, PI indicates that patients may be less tolerant to opioids after detoxification The effect of exogenous opioids was blocked approximately 28 days after vivitrol administration However, with the decrease of dependence, patients treated with vivitrol may respond to lower doses of opioids If a patient uses a previously tolerated dose of opioids, it may lead to potentially life-threatening opioid poisoning (respiratory failure or cessation, circulatory failure, etc.) Cases of opioid overdose and death have been reported in patients who used opioids at the end of the dosing interval, missed a predetermined dose or stopped treatment In addition, patients treated with vivitrol may overcome the opioid blocking effect of vivitrol Patients should be told to try to overcome the serious consequences of opioid dependence By omitting this serious and potentially fatal risk, the print ad fails to provide mat
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.