The FDA’s recent approval of Zohydro, a powerful new opioid have many people wondering why. Why would the agency tapped with safeguarding the American public from misusing dangerous narcotics introduce a new poisonous player in the cast of deadly high-dose drugs that will contribute to a national epidemic?
There is no mistaking. This drug is potent and it can kill people. According to experts, Zohydro is so strong that someone new to opioids could die of an overdose from just two pills, and a child could die from ingesting just one capsule.
According to the FDA’s web site, its best-known job is “to evaluate new drugs before they can be sold…to prevent quackery… and also provide doctors and patients the information they need to use medicines wisely. The center ensures that drugs… benefits outweigh their risks.”
Quackery. Seems like just the word to describe the FDA’s approval of Zohydro when applied to their own aforementioned guidelines. It seems that sometimes insular entities – some governmental agencies, operate within a vacuum. With the approval of Zohydro, said to be 5 to 10 times the power of Vicodin, this may be one of those instances.
Do they realize we are in the throes of an addiction epidemic? Have they not read what we’ve read, recently in a Forbes article – that the US has seen a jump in deaths – 415 percent in women and 265 percent in men, since 1999 from opiate painkillers? And these aren’t young people illegally obtaining the drugs. 60 percent of the deaths are from FDA-approved prescription medications and many of the victims are middle-aged men and women legitimately prescribed for chronic pain. Do they not recognize that the release of a stronger, higher-dose drug such as Zohydro can increase these nefarious numbers?
Mostly everyone but the FDA and the drug maker understands the danger.
In a strongly worded letter that could be titled “Just Say No to Zohydro” 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 potential to add the growing epidemic of painkiller addiction (Forbes). Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing: “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released.”
The clamoring rings from more than one advocacy group. 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.
|Deval Patrick – Republican File Photo|
One state even decided to place its own ban on distributing the new drug. Declaring a public health emergency, Massachusettts Gov. Deval Patrick last Thursday decided to place an immediate ban on Zohydro. Other states may soon follow suit.
With so many in disagreement and the obvious dangers of releasing yet another tiny pill of plunder, the only thing left to ask to the FDA is… Why?
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