Several private individuals, consumer groups and public officials are very much worried over the approval of a new controversial painkiller called Zohydro, which may bring about potential addiction and overdose among users and may contribute further to the now prevalent abuse of prescription drugs.
An extended-release version of the earlier approved hydrocodone drug, Zohydro contains the much widely used opioid and slowly releases pain-killing medication into the user's body over a 12-hour period. It is available in as extremely high dosage as 50 milligrams, which is about five times the quantity found in narcotic hydrocodone pills.
A report in 2013 by the Trust for America's Health reveals that 6.1 million of Americans misuse or abuse prescription drugs.
Concerned health officials explain the painkiller could pose a possible problem of abuse or misuse because anyone can crush it easily and then inject or snort it. Aside from that, the lack of abuse deterrents and the extremely high dosage also pose a great risk for public health.
Another thing, while opioids help in minimizing the pain, at the same time, it brings about brain stimulation, which in turn pushes further activity of neurotransmitter dopamine. This gives a sense of euphoria that lures users to get addicted to it.
"...And when the brain receives a message over and over from these opiate medications, the brain changes to adapt to that reward and that drug. So the first change in the brain is tolerance," explains licensed professional counselor Ray Isackila, who is also team leader of the addiction recovery services at the UH Case Medical Center based in Cleveland, Ohio.
Isackila says users run the risk of physical dependence, overdose and, worst, respiratory failure from the abuse. He elaborates that opioids conquer the brain area that is responsible for keeping us breathing and become all the more dangerous when mixed with alcohol and other substances.
Zogenix, the company responsible for the drug, reveals an abuse-deterrent form of Zohydro is in the works. The U.S. Food and Drug Administration (FDA), meanwhile, reasons out that there is a need for the drug because it helps ease severe pain of patients as well as minimizes the threat of acquiring liver toxicity that hydrocodone-acetaminophen combination drugs such as Lortab and Vicodin give. Zohydro is said to be 10 times stronger than Vicodin.
With the obvious lack of abuse-deterrent versions of Zohydro, Representative Hal Rogers interrogated FDA commissioner Margaret Hamburg on the reasons why the FDA didn't delay the approval of the drug during a March hearing over the budget of the agency. Hamburg's response to the House Appropriations Committee chairman was the lack of guarantee that these abuse-deterrent versions will work.
Regardless, addiction experts believe the potential dangers of the painkiller outweigh the arguments of the FDA.
"I treat addiction, and see countless young people come in - a lot of guys in their late 20s, early 30s - who had a sports injury and were given an opiate. I'm seeing them years later, and it's devastated their lives," Dr. Dana Jane Saltzman says to FoxNews.com.
Dr. Saltzman, who is a licensed addiction specialist and acupuncturist, likewise says if the opioids were not that available, many young people would not have been addicted.
Public officials, such as Massachusetts Governor Deval Patrick, Senator Richard Blumenthal of D-Conn. and Senator Patrick Leahy of D-Vt., also called the attention of the FDA and the federal government to rush the review of the anti-abuse properties of Zohydro, believing that the approval of the drug would worsen the abuse of painkillers.
"Given their potency and ease of abuse, we have little doubt that pure opioid products may lead more Americans to addiction, some even to heroin," Blumenthal and Leahy say in a letter on Monday to Hamburg.
On the other hand, some states are planning to ban the use of Zohydro, but the court is preventing them from doing so. For instance in Massachusetts, Judge Rya W. Zobel of the US District Court ruled out that the state government couldn't restrict the use of the drug that is considered effective and safe by the FDA. Gov. Patrick, however, isn't giving up the fight as he slapped further restrictions on the drug. It remains to be seen if this would result to another court discussion.
Vermont Gov. Peter Shumlin made similar steps to ban the use of the controversial drug, while Ohio state is said to be looking at the possibility of a similar ban. Many others are taking similar steps and even introducing bills to ban the said drug.
Even Fall River Mayor William Flanagan is appealing in a letter to President Barack Obama to intercede in the approval of the drug, asking the latter to instruct Hamburg to either command the complete removal of the drug from the market or for the drug manufacturer to reformulate the painkiller.
Close to four dozens of anti-addiction and consumer groups also signed a letter addressed to Hamburg asking for her reversal of the earlier approval of Zohydro.
