The heads of over 40 different organizations have affixed their signature to a letter that asks the US Food and Drug Administration (FDA) to keep a new opioid painkiller called Zohydro off the shelves, on account of it being addictive and lethal.
Zohydro is a high-dose, single-entity hydrocodone formulation whose highest available dosage contains up to 10 times more hydrocodone than Vicodin or Lortab. This level is enough to kill a child. Two capsules could kill an adult who lacks tolerance for opioids. In addition, it can be easily crushed, especially by those who abuse painkillers, and in its crushed state, the drug can be especially lethal.
The letter which was addressed to FDA Commissioner Dr. Margaret Hamburg, was signed by some of the most prominent addiction-treatment centers in the United States, such as Hazelden, Caron, and Phoenix House. CASAColumbia, the American Society of Addiction Medicine, Blue Cross Blue Shield, and Public Citizen, the consumer advocacy group, also signed the letter. The signatories are all members of "A Coalition to End the Opioid Epidemic."
Opioids are narcotics that contain heroin, which is an addictive drug all by itself. Opioids are often prescribed for managing pain and easing suffering at the end of life, and are very effective in the short-term treatment of severe acute pain. However, it is not meant to be taken on a daily basis over months and years, because people develop a tolerance for the drug, and this can cause an addiction, which will require increasing doses.
"Over the past 15 years, prescriptions for opioids have skyrocketed. The United States, with about 5 percent of the world's population, is now consuming 84 percent of the world's entire oxycodone supply and more than 99 percent of the hydrocodone supply," the letter stated.
Even the Centers for Disease Control and Prevention has said that prescriptions for painkillers in the country have nearly tripled over the past 20 years, and the United States' rate of abuse is 20 times greater than those of other countries with lower incomes. The CDC stated that in 2010 alone, 16,651 people died due to these drugs, compared with 4,030 in 1999.
This prompted the Physicians for Responsible Opioid Prescribing to write a petition to the FDA in 2012 asking the FDA to regulate the labeling of opioid analgesics.
With the FDA's recent approval of Zohydro for sale in the US market, the Coalition has questioned the FDA's basis for the said approval. It said that if the approval of the drug was based on FDA policies, then those policies must be revised, and the FDA must take into account recent history of deaths due to opioids like Zohydro.
"According to the CDC, the sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths. Since 1999, overdose deaths have skyrocketed, especially among middle-aged individuals prescribed opioids for chronic pain. Opioid analgesic overdose deaths have increased by 415 percent in women and 265 percent in men," the letter explained.
In the clamor for the FDA to reverse its approval of Zohydro, there is a FED UP! Rally in Washington, D.C. on September 28. The rally is being organized to provide a channel of expression and communication for people who are fed up by the FDA's history of allegedly putting the interests of opioid manufacturers ahead of public health.
"I'm not optimistic about our chances of keeping Zohydro off the market. But with a Senate investigation and a large turnout at the September FED UP! rally, we may be able to keep the next Zohydro-like opioid off the market. And we can finally hold FDA leadership accountable for more than a decade of disastrous opioid policies," said Dr. Andrew Kolodny, Chief Medical Officer of Phoenix House and President of Physicians For Responsible Opioid Prescribing, who wrote the letter to FDA in 2012.
