FDA-approved drug faces backlash

The backlash continues to grow over what critics say is a highly-addictive prescription drug that the Food and Drug Administration (FDA) approved late last year. 

Two weeks after three Republican senators urged the FDA to withdraw support for Zohydro, dozens of health organizations are joining the fight to get the drug banned. It is chemically similar to opium drugs like heroin and morphine, experts say.

{mosads}The FED UP! Coalition, which includes health experts, drug prevention specialists, and consumer advocates, wrote to FDA Commissioner Margaret Hamburg on Wednesday, arguing that the agency’s decision to approve Zohydro requires “urgent revision.”

“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” the coalition wrote. “We urge you to exercise your authority and responsibility to protect the public’s health by keeping Zohydro off the market.”

Zohydro is the first FDA-approved drug that uses pure hydrocodone to treat chronic pain, while other combination drugs mix hydrocodone with weaker, non-addictive painkillers such as aspirin to balance out the effects.

The FDA approved Zohydro last October, contrary to the recommendation of one of its own advisory panels a year earlier, which warned against it, because of the high levels of hydrocodone contained in the drug.

But the health groups say they are concerned the FDA’s decision could increase prescription drug overdose rates and lead to abuse of the painkiller. Addiction is particularly high among middle-aged people who are prescribed opioids for chronic pain, but then become addicted, the coalition said.

Hydrocodone is one of the most commonly abused medicines in the United States, according to the Drug Enforcement Administration. In fact, this country consumes more than 99 percent of the world’s hydrocodone supply, but makes up only about 5 percent of the population, the coalition said.

Doctors say the numbers speak for themselves.

“There is no need for another high-dose, single-entity opioid,” the coalition wrote.

The three senators also said the Zohydro poses a “significant danger” to the public and “undermines” their efforts to curb prescription drug abuse.

“This decision contradicts the FDA’s own advisory panel, and could undermine the important measures taken by the FDA, lawmakers, and state attorneys general to curb prescription drug abuse across the country,” wrote Senate Minority Leader Mitch McConnell (R-Ky.), Sen. Lamar Alexander (R-Tenn.), ranking member on the Health Committee, and Sen. Tom Coburn (R-Okla.).

Zohyrdo is scheduled to hit the market in March.