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.
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.