Senator Joe Manchin Calls For Government Ban Of Painkiller Zohydro

Earlier nowadays, Senator Joe Manchin (D-W.Va.) submitted a bill demanding that the Food and Drug Administration (FDA) rescind its approval of the painkiller Zohydro, which a increasing coalition of critics believes could turn out to be the next Oxycontin in the epidemic of prescription painkiller addiction.

The “Act to Ban Zohydro,” as Manchin referred to as his bill, delivers a 13-stage argument as to why the drug is merely as well unsafe and the FDA’s approval must be overturned.

Why Are Professionals Concerned About Zohydro?

Zohydro ER is a potent extended release formulation of hydrocodone, the opiate that’s the main ingredient in Vicodin amongst other drugs.

The difference is that Zohydro is ten times as powerful as any other hydrocodone-primarily based opiate painkiller available – critics contend that two capsules could be fatal to someone with out a higher tolerance for opiates, and a single pill could kill a child. If brought to market place, it would be the only drug that utilizes hydrocodone alone to deal with continual soreness.

Senator Joe Manchin (D.-W.Virginia) urges a ban of super potent opiate painkiller Zohydro – prior to it is brought to industry. (Photo: public domain)

Senator Joe Manchin (D.-W.Virginia) urges a ban of super potent opiate painkiller Zohydro – prior to it’s brought to market place. (Photograph: public domain)

Between Manchin and colleagues’ major factors:

• Deaths from prescription opioids have quadrupled in 10 many years from more than 4,000 in 1999 to 16, 651 in 2010.


• The FDA itself has announced that death and addiction from prescription painkillers has grow to be a national epidemic.


• Zohydro’s time-release formula could easily be altered by abusers to obtain a “heroin-like impact.”


• The FDA’s own advisory committee recommended against approval of Zohydro.


• The CDC has announced that lowering deaths from painkiller overdose and abuse is a primary objective for 2014.


• The public burdens that Zohydro would impose “outweigh its therapeutic potential” given that there are many other hydrocodone-based mostly painkillers – and other discomfort prescription drugs and ache control approaches – offered.
  
  

Two weeks in the past, I reported on the expanding movement among physicians, lawmakers, addiction professionals, and law enforcement specialists calling themselves Fed Up to flip close to the FDA’s approval procedure primarily based on Zohydro’s prospective for abuse and addiction. In what I termed a Just Say No to Zohydro campaign, more than forty specialists wrote a letter to FDA Commissioner Margaret Hamburg arguing that the FDA was mistaken in approving Zohydro ER,  the growing epidemic of painkiller addiction.

My story also obtained an onslaught of comments from chronic soreness sufferers arguing that they want Zohydro, and their opinions are well worth reading as well.

In the previous two weeks, Manchin and Senator Charles Schumer (D.-New York) have named on Wellness and Human Providers chief Kathleen Sibelius in letters to overturn the FDA’s approval.

In Senate hearings nowadays, FDA Commissioner Margaret Hamburg fought back, calling Zohydro “unique” and saying the drug’s positive aspects in treating continual soreness treat ache need to outweigh fears of its prospective for abuse.

The motion to ban Zohydro is a bipartisan effort – the Fed Up letter to Hamburg was signed by three Republican senators, Mitch McConnell (R-Kentucky), Lamar Alexander (R-Tennessee), and Tom Coburn (R-Oklahoma). McConnell is Senate Minority Leader and Alexander is a ranking member on the Health Committee.

A Senate overturn of an FDA approval for Zohydro would have a variety of dramatic longterm consequences, such as setting a precedent for this kind of action. There would also be enormous consequences for Zogenix, Inc., the maker of Zohydro, which noticed its stock drop in relation to the preceding skilled protest campaigns.

Zogenix’ techniques in winning approval for Zohydro have also come below fire.

A number of weeks ago, according to blog TheHill, Manchin and Senator David Vitter (R-Louisiana) began hunting into expenses of undue influence by the pharmaceutical sector right after complaints started surfacing that sector lobbyists contributed much more than $ ten,000 to acquire meetings with the FDA to discuss Zohydro.

Just a week ago, Zogenix, Inc. announced that it would commence providing Zohydro to a limited variety of pharmacies. Shares of Zogenix closed up 4.6 % at $ 3.67.

For much more news about Zohydro and other health topics, stick to me here on Forbes.com, on Twitter, @MelanieHaiken, and subscribe to my posts on Facebook.

Senator Joe Manchin Calls For Government Ban Of Painkiller Zohydro

Is Zohydro, The Super Potent New Opiate Painkiller, Just Too Unsafe?

A new opiate painkiller with five to 10 instances the energy of Vicodin, set to hit the marketplace in March, could trigger a disastrous spike in overdoses and deaths, says a effective coalition of doctors, lawmakers, and addiction specialists.

In a strongly worded letter that could be titled “Just Say No to Zohydro” far more than 40 experts urged the Food and Drug Administration (FDA) to reconsider its approval of Zohydro ER, a potent extended release formulation of straight-up hydrocodone, citing its prospective to include to the increasing epidemic of painkiller addiction.

“In the midst of a significant drug addiction epidemic fueled by overprescribing of opioids, the really final thing the nation needs is a new, dangerous, substantial-dose opioid,” the authorities wrote, addressing FDA Commissioner Margaret A. Hamburg, MD.

One member of the letter-writing coalition, Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, was more blunt: “It’s a whopping dose of hydrocodone packed in an straightforward-to-crush capsule. It will kill men and women as quickly as it is released.”

This isn’t the very first group of professionals to beg the FDA to reconsider. A coalition of Congressional representatives and state Attorney Generals has also urged the FDA to listen to its own advisory panel, which voted 11 to 2 against approving Zohydro.

What’s all the fuss about? Plenty. Zohydro is so strong that an individual new to opioids could die of an overdose from just two pills, the professionals say. And a little one could die from ingesting just 1 capsule. In accordance to the FDA’s evaluation, the relief – or the substantial – of Zohydro can last up to 12 hrs per dose.

An ad for Zohydro ER, which professionals say is as well dangerous and ought to not have obtained FDA approval.

The CDC’s data on opioid painkiller deaths speaks for itself, exhibiting that deaths quadrupled in a 10 12 months period. Among 1999 to 2010, the number of U.S. drug poisoning deaths involving an opioid analgesic went from 4,030 to almost 17,000, now topping people from heroin and cocaine mixed. CDC data display that prescriptions for painkillers have nearly tripled above the previous two decades, and 5 million Americans are dependent on the painkillers.

There is no disagreement that we’re in the middle of an epidemic of painkiller abuse. Given that 1999, the U.S. has seen deaths from opiate painkillers jump by 415 percent in ladies and 265 percent in men. And this isn’t just black-marketplace drugs – the biggest victims are middle-aged men and women legitimately prescribed the medication for persistent pain, the experts say. Nearly 60 percent of all drug overdoses are from FDA-accredited prescription drugs, not illegal drugs. In accordance to Forbes’ personal Robert Pearl, MD, three in four drug overdose deaths are due to an opioid painkiller such as oxycodone, hydrocodone or methadone.

The question, professionals say, is do we want a new opiate painkiller at all, given that we seem to be unable to avoid the ones we already have from ending up in the wrong hands? A drug this sturdy has huge likely for abuse, and the U.S. does not have a good track record in avoiding that from taking place. The death of Philip Seymore Hoffman put a spotlight on the possible of oxycodone, Vicodin, and other painkillers to set folks up for heroin addiction, which has also been on a quick rise in the U.S. above the previous number of many years.

The U.S., with just 5 percent of the world’s population, now accounts for 84 percent of global oxycodone (Oxycontin) consumption and a lot more than 99 % of hydrocodone (Vicodin, Lortab) consumption. That is a great deal of painkillers.

Zohydro ER was authorized by the FDA on October 25, 2013. Pharmaceutical professionals have expressed shock that  Zohydro was accredited with no an “abuse-deterrent” formulation, which implies a formulation like additives like naloxone or niacin that cause undesirable side effects when the drug is snorted or injected but are tolerable when taken orally as prescribed.

The primary issue that sets Zohydro apart – other than its strength – is that it doesn’t contain acetaminophen, as Vicodin does, and it is on this basis that its maker, Zogenix, has argued that it is safer than the options. That’s simply not true, argue its opponents, who stage out that there are lots of other opiate painkillers already on the industry that don’t include acetaminophen. Zohydro is anticipated to be accessible as early as March.

In addition to Kolodny, the coalition, which calls itself Fed Up, unites medical professionals, pharmaceutical business professionals, advocacy groups, and addiction professionals, including G. Caleb Alexander, MD, Co-director of the Johns Hopkins Center for Drug Security and Effectiveness Stuart Gitlow, MD, President of the American Society of Addiction Medication Daniel Busch, MD, of the Feinberg College of Medication at Northwestern University.

In response to previously expressed concerns, Zogenix has established a secure-use board of specialists outdoors the company to help in overseeing “appropriate use” of the drug.

For more overall health information, comply with me here on Forbes.com, on Twitter, @MelanieHaiken, and subscribe to my posts on Facebook.

Is Zohydro, The Super Potent New Opiate Painkiller, Just Too Unsafe?