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Health & Fit FDA issues warning letter to Alkermes over opioid addiction treatment ad

20:05  11 december  2019
20:05  11 december  2019 Source:   reuters.com

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A print advertisement of Alkermes Plc's addiction treatment , Vivitrol, is false or misleading as it omits important risk information associated with its Vivitrol is safe and effective for the prevention of relapse to opioid dependence when used as provided in the FDA -approved product labeling, the FDA said.

A print advertisement of Alkermes Plc's addiction treatment , Vivitrol, is false or misleading as it omits important risk information associated with its Vivitrol is safe and effective for the prevention of relapse to opioid dependence when used as provided in the FDA -approved product labeling, the FDA said.

A print advertisement of Alkermes Plc's addiction treatment, Vivitrol, is false or misleading as it omits important risk information associated with its use, the Food and Drug Administration said in a warning letter to the company.

Users of Vivitrol as a treatment for 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 the treatment, the agency said in the letter dated Dec. 2.

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(Reuters) - A print advertisement of Alkermes Plc's addiction treatment , Vivitrol, is false or misleading as it omits Users of Vivitrol as a treatment for 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

(Reuters) – A print advertisement of Alkermes Plc’s addiction treatment , Vivitrol, is false or misleading as it omits Users of Vivitrol as a treatment for 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

Vivitrol, used to prevent a relapse to opioid dependence following detoxification and to treat alcohol dependence, is one of Alkermes' top-selling drugs and brought in $85.2 million in the latest reported quarter.

It blocks the effects of opioids for about 28 days after administration. But as the blockade wanes and eventually dissipates, patients may respond to lower doses of opioids than earlier, leading to potentially life-threatening intoxication, the FDA said.

Cases of 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 the treatment, the agency said.

Alkermes is committed to working with the FDA to ensure that all promotional materials are fully compliant with applicable laws and regulations, the Dublin-based drugmaker said in an email to Reuters.

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FDA issues warning letter to Alkermes , Inc., for misbranding the drug Vivitrol (an extended-release injection The warning letter posted today reflects the agency’s commitment to protect the public health by There are three drugs approved by the FDA for the treatment of opioid dependence

FDA issued a warning letter to Alkermes , the makers of Vivitrol, for FDA warning letter slams maker of opioid addiction drug for 'misleading' ad that fails to tell patients it could raise overdose risks. In ads , the drug was marketed as being 'a non- addictive , once-monthly treatment option'.

Vivitrol is safe and effective for the prevention of relapse to opioid dependence when used as provided in the approved labeling, the FDA said.

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usr: 1
This is interesting!