The first part of this article series, Sober Living News: FDA Approves Stronger Painkiller Called Zohydro ER (Part One), introduced a new drug called Zohydro ER, which the FDA recently approved. However, there are some dangers and serious concerns being raised around the country including those in sober living communities.
First, unlike other painkillers Zohydro ER is not available in an abuse-resistant formula. There are plans to develop one. Meanwhile, the makers of the drug, Zogenix, are making available pill bottles with combination locks on the caps and lockboxes for storing the drug.
In response to the criticism that the FDA is receiving for approving the drug, they have announced that they felt an obligation to approve Zohydro ER to provide other treatment options for those who live in chronic pain. Over 100 million Americans living in pain are required to consistently take pills throughout the day, as mentioned in the first article of this series. This new drug provides them with the option of an extended release medication formula.
Nonetheless, the powerful nature of Zohydro ER puts those who have been or still are in sober living facilities recovery from addictions at risk for relapse. For those who are in chronic pain and are also attempting to break through an addiction, this is a dangerous drug.
It should be noted that the FDA is doing their best to restrict access to the drug and prevent addiction. The following are the measures they have put into place to avoid abuse and addiction in those who take Zohydro ER:
- Eliminated automatic refills.
- Strengthened the language on warning labels.
- Approved a prescription medication that can be used as an injection.
- Monitoring abuse, addiction, overdoses and deaths.
- Monitoring a reaction called hyperalgesia, a condition that makes users of painkillers even more sensitive to pain over time.
Those members of the FDA who voted against approving the drug said that they were not only considering the large number of drug overdoses and lives lost but also the red flags raised during the clinical trials of Zohydro. For instance, apparently there were not significant reductions in the levels of pain reported by trail participants. And, some participants felt that a 12 week trial was not long enough to determine whether the drug was effective or not. A number of patients had to leave the study because they had serious adverse side effects or didn’t comply with the terms of the trial. Many could not account for all of the pills they had been given.
Furthermore, it should be pointed out that many experts do not recommend opioids for chronic pain. One doctor, anesthesiologist and FDA committee member, Dr. Vesna Jevtovic-Todorovic, said, ““When you talk to pain specialists in our field, they will all tell you one indisputable fact — opiates are lousy drugs to treat chronic pain.”
Despite the FDA approval, there were five deaths in the trial of the drug and many participants did not make it through the year of testing the drug. Of those who died, two lost their lives to serious terminal illnesses; one participant committed suicide, one died of a toxic mix of drugs, and another committed suicide 13 months after the study ended.
Of course, the most vocal group that opposes the drug are parents who have already lost children to the abuse and addiction to painkillers. And at the same time, there are many people who live with chronic pain who are happy with the option of an extended release medication formula. For those who didn’t make it to a sober living program and lost their lives to painkillers, the approval of the drug is another danger. And for those who are in chronic pain, the approval of the drug is a blessing.
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