Groups Want Painkiller Zohydro to be Revoked by FDA

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Zohydro Pill

Addiction experts, physicians and more than 40 other health care officials, are urging the Food and Drug Administration to revoke approval of the prescription drug Zohydro.

The FDA approved the medication last fall to treat chronic pain, and it is set to become available to patients in March.

The opioid drug contains a potent amount of an active ingredient that could be lethal to new patients and children and is not safer than other current pain drugs, the groups told the Food and Drug Administration.

“Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” they wrote in a petition to FDA Commissioner Margaret Hamburg, dated Wednesday.

“You’re talking about a drug that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” said Dr. Stephen Anderson, a Washington emergency room physician. “I’m five times more concerned, solely based on potency.”

“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,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg. “Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” added Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”

The same concerns are seen by the entire coalition group, mostly about the drug’s potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will increase already-rising overdose numbers.

Zohydro can contain as much as 10 times the amount of the narcotic hydrocodone as other painkillers such as AbbVie Inc’s Vicodin or UCB Inc’s Lortab, advocates said in their petition.

“Zohydro is not safer,” they wrote.

“This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider the approval.

According to the Centers for Disease Control and Prevention, prescription opioid deaths more than quadrupled since 1999 — there were 4,030 deaths involving the drugs in 1999, compared with 16,651 in 2010.

Both Zohydro’s maker, Zogenix, and the FDA believe the drug’s benefits outweigh its risks.

“We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids,” said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail to CNN. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”

Anti-addiction groups push FDA to revoke approval of Zohydro

In a petition to the U.S. Food and Drug Administration, anti-addiction groups call the newly-approved drug Zohydro the next Oxycontin and they are warning if it is released to pharmacies as scheduled, it will also lead to more addiction and drug-related deaths.

FDA approves addictive opioid 10X stronger than Vicodin

The FDA just approved a controversial, highly addictive painkiller known as Zohydro. It’s 5-10 times stronger than Vicodin and retains its potency even when crushed, making it an easy target for abuse.

Related Stories:

Hydrocodone Without Acetaminophen & 10 Times Stronger Than Vicodin Being Created
Oxycodone and Hydrocodone Prescriptions On the Rise, Addiction Epidemic
Generic OxyContin Banned by FDA Until Reformulated to Help Abuse
Prescription Painkiller Deaths Across New York City Increased by 65% in 6 Years

5 COMMENTS

  1. What about the people suffering from intractable pain? People can whine and cry about the deaths of the abusers. But, abusing is their choice. The abusers know the risk. Unless a person has had a serious injury or debilitating disease, I think it is pretty hard for them to understand just how important this pain killer is for the suffering. As far as the addicts are concerned, they are more an example of our failed mental health system. They will still be addicts with or without this pain killer. They have few options for getting off drugs and the facilities that exist are underfunded and overloaded. Don’t punish the suffering people just because you think you represent the moral high ground. You aren’t fixing anything.

    • One doctor said “did our pain become so much worse in the past 20 years that we have to keep making stronger, more addicting drugs?” Well of course not! The FDA needed to get into the action of drug dealing. It’s very profitable for them! Stop fooling yourself! The governement makes more money when people become addicted. I think your attitude would change if you had someone you loved become addicted to one of the FDA’s new money makers or if your child or grandchild accidentally got into it and died. They are drug dealers and killers with a license to do so! They will kill people, they will destroy lives! They will cause more addiction, sadness and crime! By the way, it’s not really all their choice, it the pushers choice too. The FDA just gets away with being a pusher. They’ve been warned by experts and they don’t care. The only people excited about this drug are the FDA and people who are already addicted and the doctors that just keep writing prescriptions unecessarily for the money!

  2. This is very unfortunate that they are trying to ban this medication. It all comes down to uneducated doctors prescribing medicine to people who do not need them or lying people. When someone who is in chronic pain and absolutely miserable can not walk into their doctor’s office and obtain medication without the doctor being overly cautious it makes normal law abiding citizens lives miserable. Let the drug addicts and dealers die of this medicine because people who actually need it shouldn’t be left in pain. I can not pick up my two year old son anymore because my RA is so bad I can no longer concentrate on normal tasks and thanks to druggies I can’t get the pain relief needed. Please go die quickly and stop caring about them because I am tired of being in misery. Simple Vicodin just doesn’t cut it 🙁 especially when you have a disorder that makes food and medicine absorption about 10% that of a normal person.

    • Hydrocodone is still better than Oxycodone as far as instant addictions go. I don’t think it would bring NEW users in, so I don’t see what the big deal is. And I don’t know why these people think the FDA cares about people’s health! The only way they’d remove it, is if these groups can match the money given by the pharmaceutical industry.

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