By Ashly Ibarra
The parents of a 26-year-old California man are suing the Waltham, Massachusetts manufacturer of Vivitrol. They decided to sue after their son died of an opioid overdose from the medication that was treating his addiction.
The family is suing for wrongful death since the manufacturer,Alkermes, allegedly did not warn about the high risk of overdose when patients stop taking Vivitrol and relapse into opioid use. The company stands by “the efficacy and safety of Vivitrol and will vigorously defend the matter.”
Vivitrol is one of the three new medications that treat opioid addiction. The suit against Alkermes is also for the way they marketed Vivitrol. In December, the FDA accused Alkermes of “misbranding” Vivitrol by not putting a warning about the risk of overdose.
The medication is unique because it is a once a month injection that blocks opioid effects in the brain. In order to take the medication, one must be clear of all opioids in their system. If the patient misses one month of the Vivitrol shot and relapse they are now at risk of overdose because their opioid tolerance level was reduced.
Vivitrol was approved to treat opioid addiction in 2010 but it did not gain popularity right away. Leading Alkermes to market Vivitrol as a drug that is nonaddictive and non-opioid treatment. But patients who take the medication often wait until the shot wears off to resume drug use. This places them at a high risk of overdose.