Potent new painkiller stokes alarm in US
March 08, 2014
Zohydro ER can contain 10 times the amount of hydrocodone as the most popular prescription painkiller, Vicodin, and is easily crushable so it could be snorted, bearing none of the recent safeguards added to pills like OxyContin (oxycodone).
In a nation where some 15,000 people die annually from prescription painkiller use, the drug's approval has raised alarm among doctors, lawmakers and relatives of those lost to overdose.
Two senators have launched an investigation into practices by the US Food and Drug Administration, amid allegations that pharmaceutical companies eager for a chunk of the $9 billion painkiller market may have paid to influence regulators' decisions.
"It's almost unheard of," said Andrew Kolodny, president of the group Physicians for Responsible Opioid Prescribing.
"For FDA to approve a drug that is going to make a serious problem worse, it is pretty shocking."
Zohydro was approved in October 2013, even though a panel of FDA-convened experts voted against 11-2. The FDA is not obligated to follow the advice of its advisory committees, but it typically does.
An FDA spokesman told AFP the decision was made "after careful consideration," and "the product's benefits outweigh its risks when used as intended."
Zohydro contains pure hydrocodone in a range of doses, including time-release options that are much stronger than competitor products.
It does not contain acetaminophen, which can cause liver damage and death in high doses and is included in most other prescription opioids.
The drugmaker, California-based Zogenix, said in a statement that the "acetaminophen-free formulation of extended release hydrocodone is an important therapeutic option for certain chronic pain patients."
