FDA Approves Powerful Painkiller Zohydro ER

The U.S. Food and Drug Administration announced that it has approved Zohydro ER, a pure hydrocodone drug.

The drug has no added analgesic such as acetaminophen and is intended for people suffering from severe pain and only when the patients have stopped responding to any other painkiller. The newly-approved drug is manufactured by San Diego-based Zogenix.

Hydrocodone is a widely abused prescription drug. FDA has proposed for strict control over use of hydrocodone-containing drugs. The latest approval is a surprise as last year the drug had received negative reviews from FDA's advisers, The Associated Press reported.

Zohydro ER belongs to a class of medications called extended-release/long-acting (ER/LA) opioid analgesics and carries a significant addiction-risk. The agency said that the drug is only meant for people who have stopped responding to other kinds of treatments for pain.

The drug is classified as a Schedule II controlled substance under the Controlled Substances Act.

"Schedule II drugs can only be dispensed through a physician's written prescription and no refills are allowed. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances," FDA said in a news release.

To study the efficacy of the drug, researchers analyzed 500 people with chronic pain. A majority of the patients showed significant pain relief after using Zohydro ER. The safety of the drug was tested on another set of 1.100 patients.

Common side-effects of using the drug include nausea, drowsiness, headache, vomiting and constipation, the agency said.

The drug approval was criticized by drug safety advocates.                                     

"We're just going to kill more kids and then the FDA is going to come back and say, 'oh, we made a mistake,'" Avi Israel of Buffalo, N.Y., told The Associated Press. Israel began campaigning against painkiller abuse after his son Michael committed suicide while struggling with prescription drug addiction. He is the founder of a group called, 'Save the Michaels of the World.'