Experts concerned over FDA approval of potent new pain pill

John Roberts reports from Atlanta, Georgia


A coalition of experts is pushing the U.S. Food and Drug Administration (FDA) to revoke its approval of a new, highly addictive painkiller, Counsel and Heal reported.

Zohydra, a hydrocodone-based drug that is part of the group of drugs known as opioid analgesics, was approved by the FDA last fall. In March the drug will be available to patients suffering from chronic pain – despite the fact that opioid analgesics have proven to be addictive.

Now, FED UP!, a coalition of more than 40 health care, consumer and addiction rehabilitation groups is expressing concern that the drug – which contains a high dose of hydrocodone and is easy to crush – may be too easy to abuse.

"In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid," the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg, as reported by CNN. "Too many people have already become addicted to similar opioid medications, and too many lives have been lost."

The FDA and drug-manufacturing company, Zogenix, have stated that the drug’s benefits outweigh the risks. Zohydra will be sold with warnings regarding abuse, addiction and misuse but doctors are still concerned.

"The technology is out there to make this a safer pill. They just chose not to use it," Dr. Charles Reznikoff, of the Hennepin County Medical Center, told Fox 9 News. "I would never prescribe it or recommend that it be prescribed. I would also recommend that the insurance companies not make it available to patients."

Click for more from Counsel & Heal.

Click for more from My Fox Twin Cities.