FDA Warns Of Potential Complications From Vivitrol

Specifically, the FDA said the warning label for Vivitrol notes that ... health perspective because of the potential for fatal opioid overdose in this.... FDA warns Alkermes over Vivitrol misbranding. ... injection formulation of naltrexone) by omitting warnings about the most serious risks ... labeling, including vulnerability to opioid overdose, a potentially fatal risk, said the FDA.. The active ingredient in VIVITROL (naltrexone for prolonged-launch injectable suspension) naltrexone works as a blocker. medication revia attaches to.... FDA issues warning letter to Alkermes, Inc., for misbranding the drug Vivitrol (an ... of naltrexone) by omitting warnings about the most serious risks associated ... including vulnerability to opioid overdose, a potentially fatal risk.. response to an FDA Warning Letter issued on December 2, 2019: ... recognize the importance of accurately communicating the benefits and risks of our medications. ... setting prior to initiation of treatment with VIVITROL. ... could result in potentially life-threatening opioid intoxication (respiratory compromise.... The FDA has issued an alert to healthcare professionals about the risk of adverse skin ... The FDA warned that the drug should not be injected subcutaneously, ... made that much harder do to the adverse side effects of the injection of V. ... to review your comments and contact you about a potential case.. The FDA takes issue with a print advertisement for Vivitrol that fails to ... its drug naltrexone in promotional materials regarding the most serious risks ... to opioid overdose, a potentially fatal risk, the FDA said in a statement.. Alkermes omitted warnings about serious risks from taking the drug. ... FDA warned Alkermes for misbranding Vivitrol, ... listed in the product labeling, including vulnerability to opioid overdose, a potentially fatal risk, FDA said.. Here, the pharmaceutical liability attorneys at Peter Angelos, P.C. discuss the potential risks of Vivitrol and the consequences to Alkermes for allegedly failing to.... Vivitrol official prescribing information for healthcare professionals. ... This makes the blockade produced potentially surmountable, but overcoming ... Patients should be warned of the risk of hepatic injury and advised to seek.... FDA warns Alkermes about leaving overdose, other Vivitrol risks out of ads ... including vulnerability to opioid overdose, a potentially fatal risk... If you are pregnant only take Vivitrol if the potential benefits outweigh the potential risk to the fetus. ... You may report side effects to FDA at 1-800-FDA-1088.. This could result in potentially life-threatening opioid intoxication (respiratory ... OPDP said it's concerned that Alkermes continues to promote Vivitrol in a manner that ... In response to the warning letter, FDA is seeking by next Monday ... of accurately communicating the benefits and risks of our medications.. and patients are vulnerable to potentially fatal overdose at the end of a ... See 17 for PATIENT COUNSELING INFORMATION and FDA-approved ... WARNING: To reduce the risk of a needlestick: ... Patients should be made aware of the risks.. Alkermes's long-acting addiction medication, Vivitrol, leaves some former users ... The company's ad should warn them, the FDA says. ... does not warn users that they are more vulnerable to a potentially fatal ... one of the most serious risks of using the product: the increased chance of an opioid overdose.. FDA blasts Alkermes for underselling the risks of opioid addiction ... to warn patients and doctors of the serious risks associated with the drug.. The Washington Post: FDA Warns Company Over Ad That Leaves Out ... Vivitrol does not warn users that they are more vulnerable to a potentially fatal overdose ... Stat: FDA Blasts Alkermes For Underselling Risks Of Vivitrol. Alkermes Receives FDA Warning Letter About Misbranding Vivitrol ... of naltrexone) by omitting warnings about drug-related risks from ... from a public health perspective because of the potential for fatal opioid overdose in this.... The Food and Drug Administration (FDA) has issued a warning letter to ... claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, ... This could result in potentially life-threatening opioid intoxication.... FDA warns of potential complications from Vivitrol. By Alaric DeArment - 08/13/2008. Get great content like this right in your inbox. Subscribe. WASHINGTON The...

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