The FDA Issues Warning Letter to Vivitrol Manufacturer Alkermes for Omitting Risk Information
In December 2019, the Food and Drug Administration (FDA) sent a warning letter to Alkermes, the manufacturers of the drug Vivitrol, for a print advertisement that misled consumers by omitting important risk information. By failing to admit the potentially fatal consequences of opioid intoxication, the safety of Vivitrol is now being called into question. 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 notify consumers of these risks.
Background of Vivitrol and Risks Associated
Vivitrol, otherwise known as Naltrexone, is an injectable medication to help individuals maintain abstinence during recovery from an opioid or alcohol dependence. Manufacturers of the drug claim that a Vivitrol injection temporarily blocks receptors so an individual will not experience the high from opioids. However, in recent months, Alkermes has been under fire by the FDA for creating a misleading impression of Vivitrol’s safety. During a time where the opioid crisis impacts millions of people and is a prevalent epidemic in our society, safety for consumers and risk of addiction is of utmost concern.
Specifically, marketing materials focused on the benefits of Vivitrol for individuals with a dependence on drugs or alcohol, and excluded the potentially fatal risks associated with the medication.
The FDA’s press release clarifies that Vivitrol is designed to block the effects of opioids for 28 days after injection. Vivitrol has failed to warn or educate patients receiving Vivitrol shots that tolerances may be reduced, leading to a potentially fatal overdose if the patient returns to the same usage after treatment. Furthermore, there is a risk of individuals becoming immune or resistant to the effects of Vivitrol, leading to potential relapse in opioid or alcohol abuse.
Vivitrol is Heavily Supported by the Criminal Justice System
Approved in 2010 after a trial completed in Russia, Vivitrol’s sales have continued to increase to over $200 million per year since 2018. With a cost of up to $1000 per shot, many individuals have found themselves reliant on Vivitrol as a means to achieve sobriety. Based on this report, Vivitrol has been marketed to the criminal justice system as a means of alternative opioid addiction care.
Alkermes Released Media Statement Regarding FDA Warning Letter
In response to the FDA warning letter about Vivitrol, Alkermes released a media statement regarding the allegations and expressed their concern for the safety of their patients. While Alkermes is working alongside the FDA to address the situation, this does not excuse the lack of information present on their advertisements and the potential injuries that may have occurred as a result. Office of Prescription Drug Promotion director Thomas Abrams stated, “this is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population.”
File a Claim with the Help of a Pharmaceutical Liability Attorney at Peter Angelos, P.C.
It is the responsibility of organizations such as the FDA, as well as international corporations like Alkermes, to be transparent in the labeling and associated risks with their products, especially those prescribed to vulnerable populations such as those addicted to opioids or alcohol. If you or a loved one has been adversely affected by Vivitrol during opioid recovery, schedule a free consultation with the Law Offices of Peter Angelos P.C. today.