The FDA’s approval of a new medication is often welcomed, especially by those who would benefit from its use. However, one recently-approved drug, Zohydro ER, is drawing criticism from a coalition of concerned groups, including addiction specialists and emergency room professionals. Critics contend the prescription medication, which is expected to hit the market in the spring of 2014, isn’t safe because it has the potential for abuse, drug addiction, and lethal overdoses.
The active ingredient in Zohydro is the synthetic opioid hydrocodone. Hydrocodone has been used for years to treat pain, often through the familiar medication Vicodin. The difference, however, lies in the formulation. Zohydro delivers up to 10 times more hydrocodone found in any other painkillers. It’s also an extended release pill that treats severe pain for 12 hours.
This extremely potent drug isn’t intended for those who need relief for minor conditions, such as a pulled muscle. Instead, it’s formulated to be used only when other medications or therapies haven’t relieved serious and persistent pain. For example, Zohydro has already been used to treat individuals with metastatic cancer, chronic back pain not helped by surgery, and multiple broken bones.
Why Critics Are Concerned
The FDA approved the drug, even though an expert panel recommended – in an 11 to 2 vote – against approval, citing concerns over the potential for abuse and addiction. The FDA’s action generated a firestorm of controversy from other groups as well. The attorneys general from 28 states, as well as addiction treatment providers, emergency room professionals, and other groups have petitioned the FDA to reconsider approval, naming several concerns:
High Potential for Abuse
Painkiller abuse has risen dramatically in the United States. Nearly 75% of prescription drug overdoses today are by opioid pain relievers, according to the Centers for Disease Control and Prevention (CDC). The problem is increasingly prevalent among women. Deaths from prescription painkiller overdose in women have spiked 400% since 1999. Critics argue the high level of hydrocodone found in Zohydro will contribute to this growing drug abuse problem.
High Potential for Addiction
Even when taken as prescribed, Zohydro is a powerful drug that increases the risk of addiction. Like other opioids, it causes a tolerance build-up over time, so a person requires increasingly larger doses to feel its pain-relieving effects. Furthermore, addiction risk increases when the drug is taken in a way other than prescribed. When taken properly, Zohydro slowly releases hydrocodone over 12 hours. However, the drug comes in a pill form that is easily crushed, making it simple for a person to then snort or inject Zohydro. As a result, the drug abuser absorbs the full dose at once, creating an intense high that can all-too-easily lead to a very dangerous drug addiction.
Concerns about addiction and Zohydro use extend beyond the drug itself. People addicted to prescription opioid painkillers are more likely to start abusing heroin. Abuse of this illicit drug has risen substantially in recent years, increasing by as much as 80% between 2007 and 2012. Part of the increase is believed to stem from the rise in prescription pain pill addiction. Some painkiller addicts transition to heroin when the prescription drugs become too expensive or when it becomes too hard to obtain them from a physician. Zohydro ER addiction will likely add to the growing number of heroin addicts.
One of the challenges with Zohydro use is that there’s little room for error when it comes to dosing. Doctors have warned that the drug is so powerful that just two pills have the potential to kill an adult, while a single pill may prove lethal to a child. Even a patient using the medication as prescribed might make an error that leads to a fatal overdose. In addition, those who abuse Zohydro by snorting or injecting it will be subjected to very high doses of hydrocodone. If they’re not accustomed to taking the drug at those levels, the risk of overdose or death increases substantially.
Despite concerns, advocates contend that Zohydro ER, when prescribed by a physician and used as intended, has a legitimate place in medicine. The drug can bring much needed relief to individuals debilitated by chronic pain who haven’t been helped by other pain management strategies. In trials, people taking Zohydro reported significantly improved pain relief over placebo. Additionally, it was generally well tolerated in those who received the drug.
According to makers of Zohydro, the potent painkiller offers round-the-clock pain management without the liver toxicity linked to other painkillers, such as Vicodin, which also contain acetaminophen. In fact, acetaminophen overdose has become a serious problem, spurring the FDA to issue a warning to limit its daily use. Liver damage can easily happen, especially when a person combines medications containing the potentially toxic substance. Zohydro ER reduces the risk that a patient will take too much acetaminophen.
Making Zohydro ER Safer
Addiction experts argue that Zohydro’s manufacturer hasn’t done enough to reduce the risk for abuse. For example, the producers of other drugs with abuse potential have formulated pills that break into big chunks when crushed, making them harder to inject or snort. Others have created pills that turn into a thick, uninjectable sludge when mixed with liquid. Although such changes would make Zohydro less attractive to those looking for a fast and powerful high, they still wouldn’t reduce the risk of abuse, addiction, and lethal overdose in pain patients taking the drug as prescribed.
Zohydro ER will likely offer needed relief for those who haven’t been helped by other pain medications or treatments. However, legitimate concerns about its current formulation remain, including an elevated risk for overdose, abuse, and drug addiction.