The FDA in the United States are seeking to ban the opioid drug, Opana ER from the market in a bid the reduce the harmful effects of such drugs on the public.
In a statement FDA Commissioner Scott Gottlieb, M.D. said: “We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse”. He added that “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Opana ER has been on the market since 2006 when it was approved as a treatment for moderate-to-severe pain. However, the FDA now believes that the drug may be causing more harm than good.
The United States is currently experiencing a major crisis in deaths from opioids. Opioids were involved in more than 33,000 deaths in 2015 and opioid overdoses have quadrupled since 1999, according to the Centers for Disease Control and Prevention.
Public health officials have called the current opioid epidemic the “worst drug crisis in American history”. The National Institute for Drug Abuse estimates that there 2.1 million people in the US who suffer from the effects of opioid addiction. Prescriptions for opioids have been growing year-on-year since the 1990s. The Institute has identified some key factors, which they believe to have driven a rise in the opioid crisis in the US. They believe that there is a greater social acceptance for using prescription medicine for a multitude of problems, a drastic increase in the number of prescriptions written and dispensed, and aggressive marketing by pharmaceutical companies.
There are many harrowing stories from across the United States as to impact that opioid drugs are having on individuals. In Philadelphia, librarians have become accustomed to the know the sound of an overdose in the bathrooms of public libraries by the sound of a body hitting the floor. In Utah, former industrial towns have been ravaged by opioid abuse, supplied to workers of mines and power plant facilities. Many of the victims of opioid abuse hail from white, middle class, suburban and rural towns. Now, middle-aged white Americans are 45% more likely to die than middle-aged Germans.
Such startling statistics have pushed the FDA into tackling the problem head-on. The organisation has said that they will continue to examine the risk-benefit of all approved opioid medicines and take further action if they believe that the public’s health is at risk.