(NEW YORK) — A new opiate painkiller approved by the U.S. Food and Drug Administration has come under fire from health care advocates who say the medication may be too dangerous to be on the market.
The painkiller Zohydro is said to be 10 times more potent than Vicodin. As a result, the drug has made many health care advocates nervous about the possibility of an increase in overdoses and addiction related to opioids.
In December, 28 state attorneys general wrote to FDA commissioner Margaret Hamburg asking her to reconsider the approval of the drug or to impose additional restrictions on it to deter drug abuse.
“State attorneys general do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed,” the attorneys general wrote in their letter.
The drug was approved in October of last year.
ABC News’ chief medical correspondent Dr. Richard Besser said that the drug pitted doctors treating patients with chronic pain and those treating patients with addiction against each other.
“There are millions of people with chronic pain and the FDA says this gives them another tool for people who aren’t being well handled by the existing drugs,” said Besser on Good Morning America. “The addiction community is very concerned because prescription pain medications are the gateway to heroin.”
However, while other opiates, including a reformulated OxyContin, have abuse deterrent qualities that make them harder to crush and snort, Zohydro has not been reformulated.
A grassroots group called Fed Up, which is made up of family members who have lost loved ones to opioid overdose, started a Change.org petition to get the FDA to reverse their approval of the drug.
“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” reads the petition on Change.org.
The FDA could not be immediately reached for comment.
Health officials have had an increasingly difficult time handling opiate abuse as addiction and overdose rates have skyrocketed in recent years.
The U.S. Centers for Disease Control found that the number of overdoses related to opiates quadrupled from 4,030 in 1999 to 15,451 in 2010.
In 2010, nearly 60 percent of drug overdose deaths (22,134) involved pharmaceutical drugs. Of these fatal pharmaceutical overdoses, three out of every four included some kind of opioid.
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Tamsyn Valentine, FamilyShare
Lina de Florias, CNN Newswire