Powerful Narcotic Painkiller Up For FDA Approval

(Getty Images)

(Getty Images)

by Rob Stein, NPR

The Food and Drug Administration is trying to decide whether to approve a powerful new prescription painkiller that’s designed to relieve severe pain quickly, and with fewer side effects than other opioids.

While some pain experts say the medicine could provide a valuable alternative for some patients in intense pain, the drug (called Moxduo) is also prompting concern that it could exacerbate the epidemic of abuse of prescription painkillers and overdoses.

An FDA advisory committee is holding a daylong hearing Tuesday to decide whether to recommend that the agency approve the drug.

“This is a product that is very easy to misuse, very easy to crush and snort or crush and inject,” says addiction specialist Andrew Kolodny.

Moxduo for the first time combines morphine and oxycodone in one capsule. It’s designed to provide quick relief to patients suffering severe pain from accidents or surgeries, such as knee replacements, back surgeries or cancer operations, says Ed Rudnic, COO of QRxPharma, the company that makes Moxduo.

The drug allows patients to take lower doses of the two narcotics than they’d need if they took either of the medicines alone, Rudnic says.

“We believe that we’ve achieved some benefit in reducing the risk of some of the respiratory complications of these strong opioids,” he says.

Suppressed breathing and other respiratory complications are the most serious risks of these drugs — the main reason people die from taking too much.

Some pain experts think the idea behind Moxduo is a good one. A lot of patients can’t take enough morphine or oxycodone to ease their discomfort because of the risk to breathing and other side effects, such as nausea, vomiting, dizziness and severe itchiness.

Continue reading

DEA Investigating CVS Over 37,000 Missing Pain Pills



Drug enforcement officials are investigating several CVS pharmacies in California over missing prescription painkillers – pills state officials fear may have ended up on the black market.

The company could face up to $29 million in fines as a result of the investigation.
Investigators in the Sacramento office of the Drug Enforcement Agency are specifically interested in finding out what happened to more than 37,000 tablets of hydrocodone, a narcotic typically sold under brand names like Vicodin and Norco. The pills were reported lost or stolen by four CVS stores in Fairfield, Dixon, Turlock, and Modesto, according to the DEA’s warrant applications.

“Investigators believe there will be numerous record keeping violations related to the dispensation of controlled substances within CVS,” wrote Brian Glaudel, the DEA investigator who requested the four warrants, which were served on the stores last May. “The requested inspection is warranted to protect the public health and safety.” Continue reading