Do we really need a new highly addictive opioid analgesic on the market to treat chronic pain, especially considering the high rates of drug addiction in the U.S?
The drug Zohydro is set to be marketed come March and its approval is sparking a firestorm from consumer, drug addiction and medical groups. The president of Physicians for Responsible Opioid Prescribing, Dr. Andrew Kolodny, predicts Zohydro will kill people “as soon as it’s released.” He calls it hydrocodone delivered in an easy-to-crush capsule.
A coalition of more than 40 groups together has urged the FDA to stop the approval of Zohydro, reports CNN. The group wrote a letter to FDA Commissioner Dr. Margaret Hamburg reminding her that this country is in the middle of an epidemic of overprescribing of opioids and does not need another powerful opioid on the market.
Zohydro was approved by the FDA last fall and is hydrocodone-based and prescribed to patients suffering from chronic pain from cancer, back surgeries or orthopedic fractures, among other maladies. It is reported to be five times more potent than any other drug currently on the market.
This is not the first controversy swirling around Zohydro. Twenty-nine state attorneys general have questioned the FDA about its approval. Last November members of Congress also asked the FDA to review, if not revoke, the approval of Zohydro.
Predictions are that we will see high numbers of overdoses and that Zohydro will become the next OxyContin.
The real question is why did we need another powerful opioid? In recent years the number of opioid-related deaths has quadrupled to 16,651 in 2010 compared to just over 4,000 in 1999, according to the Centers for Disease Control and Prevention (CDC).
A person is reported to die every 19 minutes from a drug overdose which now exceeds car crashes as the leading cause of accidental deaths in the U.S. Unfortunately pain pills become less effective with more use so patients increase their dose. An overdose of pain medication can cause the body to stop breathing, especially if mixed with alcohol.
Drugmaker Zogenix insists the benefits outweigh the risks and apparently the FDA agrees. The company plans to work with doctors so only those who receive much oversight prescribe to patients in pain. However, the company has a lot riding on a new drug and research and development does not come cheap. It is only a matter of time before patients ask for the newest and strongest drug on the market. It is only a matter of time before some doctors comply with the request opening the avenues to abuse.
The FDA plans to more closely regulate hydrocodone-based drugs to Schedule II from Schedule III.
That would mean more oversight in dispending these drugs. That plan was announced the day before the FDA announced it had approved the sale of Zohydro, which will fall into the Class Schedule II.