Anti-addiction groups to FDA: Reverse approval of new painkiller

Anti-addiction groups push FDA to revoke appr... 02:36

The U.S. Food and Drug Administration is facing a backlash over a painkiller it approved last year and is now set to go on sale in pharmacies next month.

In a petition from dozens of anti-addiction groups to the FDA, the groups are call the newly approved drug, Zohydro, the next OxyContin. They are warning the FDA that, if the drug is released to pharmacies as scheduled early next month, it will lead to more drug addiction and more drug-related death.

Last October, the FDA approved Zohydro for patients who suffer "pain severe enough to require daily, around-the-clock, long-term treatment."

But the power of a drug like this is the issue. Zohydro is essentially pure hydrocodone, a painkiller similar to OxyContin, and would be given to patients in doses between 10 and 50 milligrams a day - that's up to 10 times the typical dose of hydrocodone now.

One of the physicians asking the FDA to revoke its approval is Dr. Andrew Kolodny. He is the chief medical officer of Phoenix House, a clinic that treats patients for drug addiction. He said, "This is a product that's dangerous even to people who are trying to use it as directed."

Kolodny continued, "Many people are concerned that, as soon as this drug hits the market, many people will die from it. A child who's never taken an opioid before could die from taking just one capsule, and an adult who's not used to taking opioids could overdose on just two capsules."

Supporters of the drug call it essential for patients who suffer non-stop pain from cancer, back problems or arthritis and who don't benefit from less-powerful painkillers. In a statement, Zogenix, the drug's maker, called the drug a "new treatment option" for those patients and said the company was "committed to promoting the appropriate prescribing and use of Zohydro."

Still, FDA approval of the drug was unexpected and some say unprecedented.

In 2012, an FDA advisory panel voted 11-2 against Zohydro, with most of the experts fearing the drug - like OxyContin - would lead to abuse and become a threat to public health.

The FDA told CBS News in a statement that it approved Zohydro because so many patients need it and because "the product's benefits outweigh its risks when used as ... approved." But that's the heart of the controversy, CBS News' Wyatt Andrews reported: Can a drug this powerful can be kept in the box and only be used as approved?