Medical experts are urging the Federal Food and Drug Administration to reverse its approval of a new hydrocodone painkiller which they say could lead to an epidemic of addiction and overdoses. Known as Zyohydro ER, the new painkiller was approved by the FDA in Fall 2013 and is set to go on sale in March 2014. In an open letter sent to the agency, a coalition of more than 40 health care, consumer, and addiction treatment groups urged FDA Commissioner Margaret Hamburg to revoke the agency’s approval of Zohydro.
According to statistics from the Centers for Disease Control and Prevention, deaths from opioid painkiller overdose have more than quadrupled over the last 10 years—rising from 4,030 deaths in 1999 to more than 16,000 in 2010. Experts fear that the potency and abuse potential of Zohydro may cause that number to climb even further after the drug is released.
According to one doctor who signed the letter—Dr. Andrew Kolodny, president of the group Physicians for Responsible Opioid Prescribing—Zohydro is “a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it’s released.”
Experts Concerned About Abuse, Addiction Potential of Zohydro
Expert concerns about the danger of Zohydro are due, in part, to the high potency of the drug. At its highest doses, a single pill of Zohydro will contain five to 10 times as much hydrocodone as drugs such as Vicodin and Lortab. According to the open letter to the FDA, patients taking Zohydro could suffer a fatal overdose from as few as two pills.
Concerns about Zohydro have also been raised about the abuse potential of the drug. Unlike some other opioid painkillers, Zohydro does not contain abuse deterrent features that would make the drug harder to crush. As a result, experts fear that Zohydro will suffer a fate similar to OxyContin, another potent opioid painkiller that is commonly abused by addicts.
A letter of concern about the FDA’s approval of Zohydro was also sent to the agency by 29 state attorneys general in December 2013. One month earlier, several members of Congress also asked the FDA to review its decision to approve Zohydro.
Surprisingly, the FDA’s approval of Zohydro comes at a time when the agency is trying to curb the number of cases of overdose, addiction, and death caused by opioid painkillers. In October 2013—the same month that it approved Zohydro—the FDA announced plans to reclassify hydrocodone drugs from its Schedule III to Schedule II category, which would mean stricter dispensing and prescribing rules for these products. Critics expressed confusion about the FDA’s decision to approve Zohydro in light of this decision, stating that the release of the drug would contribute to the very problem that the new FDA rules about hydrocodone drugs were trying to address.
Heygood, Orr & Pearson fights for victims of opioid overdoses
If you or a loved one has been the victim of overdose caused by opioid painkillers, the manufacturer of the drug—or the doctor or hospital who prescribed them—may be to blame. Many doctors who prescribe opioid painkillers to patients have little to no experience with pain management. As a result, they may prescribe drugs that are too powerful or in doses that exceed what a patient requires. Sadly, many of these physician errors lead to addictions, overdoses, or deaths that could have been prevented.
Heygood, Orr & Pearson has represented numerous patients who have suffered complications from excessive painkiller prescriptions by a doctor or hospital. The lawyers at our firm have handled more cases involving the powerful fentanyl pain patch than all other law firms in the country combined.
Our partners—Michael Heygood, Eric Pearson, and myself—have each been selected by their peers as Super Lawyers in the state of Texas for several years in a row.* Our firm has also been given the highest possible rating for law firms by the nation’s leading law firm rating service, Martindale-Hubbell.
For more information about an opioid painkiller lawsuit and to find out if you qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form located on this site.
* Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2014.