FDA chief defends approval of hydrocodone drug

The head of the Food and Drug Administration says the much-debated painkiller Zohydro fills an "important and unique niche" for treating pain.

Dr. Margaret Hamburg defended her agency's decision to clear the drug during questioning before a Senate committee on Thursday, saying the pill from Zogenix met the government's standards for safety and effectiveness.

Zohydro is the first pure version of hydrocodone, the most abused medication in the U.S. More than a half-dozen lawmakers have criticized the FDA's approval decision, questioning why Zohydro was not formulated to thwart drug abusers from snorting or injecting it.

Hamburg cautioned that such formulations are still in the early stages of development. To date, the FDA has only approved one medication with such features: OxyContin.

"Right now, unfortunately, the technology is poor," Hamburg said.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Sen. Joe Manchin seeks to block new painkiller

Mar 11, 2014

U.S. Sen. Joe Manchin is calling on the government's top health official to overturn the approval of a powerful painkiller, arguing that the pill Zohydro could add to the national epidemic of prescription drug abuse.

US panel opposes pure hydrocodone painkiller

Dec 09, 2012

(AP)—U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone on Friday, questioning the need for a new form of one of most widely abused prescription painkillers.

Potent new painkiller stokes alarm in US

Mar 08, 2014

A potent new painkiller hit the US market this week, despite warnings from top experts that the drug may deliver a deadly setback in America's battle with opioid addiction.

Recommended for you

Boxed warnings are common in novel therapeutics

14 hours ago

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

15 hours ago

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

Perampanel for epilepsy: Still no proof of added benefit

16 hours ago

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...

User comments