Senators question FDA over recently-approved hydrocodone painkiller Zohydro

Posted
by Eric Pearson

Three Republican U.S. senators are raising concerns about the FDA’s approval of a powerful prescription painkiller called Zohydro. The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The pill is significantly more potent than currently available hydrocodone combination pills, such as Vicodin. The approval surprised many doctors, since an FDA advisory panel voted overwhelmingly against the drug, citing its potential for abuse.

Republicans Mitch McConnell of Kentucky, Tom Coburn of Oklahoma and Lamar Alexander of Tennessee sent a letter to the head of the FDA on February 12, 2014 asking how the agency will prevent misuse and abuse of Zohydro and similar drugs in development. The letter states:

… FDA has … approved a powerful, extended-release pure hydrocodone product. This decision contradicts the FDA’s own advisory panel, and could undermine the important measures taken by the FDA, lawmakers, and state attorneys general to curb prescription drug abuse across the country unless accompanied by appropriate safeguards and due consideration for the potential for abuse.

Data from the Centers for Disease Control and Prevention (CDC) show that more than 16.000 Americans die from opioid drug overdoses each year. Further, opioid analgesics, including drugs with hydrocodone, comprise approximately 75 percent of all pharmaceutical overdose deaths. We believe the approval of pure hydrocodone products without methods to prevent abuse, misuse, and diversion, including abuse-deterrent formulations, poses a significant danger to our constituents, as it could worsen the drug abuse epidemic in our country.

The Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) noted in its December 2012 report that “as a hydrocodone single-entity, extended-release product, it is expected that this drug (if approved and marketed) will be associated with higher levels of abuse than the hydrocodone combination product. These expected higher levels of abuse are based on what has been observed for oxycodone products.” Given this clear warning from the FDA’s advisory panel, we would like to know what safeguards FDA mandated for the product …

(footnotes omitted).

Specifically, the Senators have asked the FDA to provide answers to the following questions:

  1. What conditions are in place around the production and distribution of this drug, and how were those conditions evaluated to ensure their effectiveness for preventing misuse, abuse, and diversion?
  2. How does FDA balance patient needs with regard to access to safe and effective pain medication with the potential for abuse, misuse, and diversion?
  3. You have previously confirmed that the FDA has the legal authority under the Federal Food, Drug, and Cosmetic Act to require drugs, including generic versions, to have an abuse-deterrent formulation. How docs the FDA plan to use this authority in regards to approving both brand and generic opiates? Please provide examples of the circumstances in which FDA would use this authority.
  4. How docs FDA plan to monitor the abuse, misuse, and diversion of pure hydrocodone products, including overdose rates, and evaluate and update the conditions put in place to prevent such abuse, misuse, and diversion if necessary? Please include any plans to work with law enforcement and stakeholders on implementing the most effective strategies to prevent abuse, misuse, and diversion, such as the standards for and requirement of abuse deterrent formulations.

Prescription Painkiller Overdoses and Medical Malpractice

When doctors overprescribe prescription painkillers to their patients, the results can be deadly. The improper prescription of pain medications can place patients at risk of addiction and dependence. In other cases, doctors may prescribe opioid medications that are too powerful or in combination with other drugs that decrease the activity of the central nervous system, increasing the risk of an overdose.

Despite warnings from the Food and Drug Administration about the danger of opioid painkillers such as hydrocodone, oxycodone, morphine, fentanyl and methadone, doctors continue to prescribe these drugs in ways that put the health and the lives of their patients at risk. Prescription drug overdoses are now the leading cause of accidental death in the U.S., killing tens of thousands of patients each year.

If you or a loved one were the victim of a prescription painkiller overdose, the doctor or hospital who prescribed these medications may be to blame. Patients whose lives have been affected by a painkiller overdose, addiction, or other complications caused by the reckless prescription of these drugs by a physician may be eligible to file a lawsuit and seek compensation for their injuries.

The lawyers at Heygood, Orr & Pearson have represented hundreds of patients who have been harmed by opioid painkillers or other dangerous prescription drugs. Our law firm has the experience to prosecute medical malpractice cases involving a wide array of serious opioid painkillers, including Vicodin, hydrocodone, OxyContin, oxycodone, methadone, hydromorphone, fentanyl, and others. Our attorneys have tried hundreds of cases to verdict, achieving verdicts and settlements for our clients totaling more than $200 million—including more than $50 million in 2010 alone.

For a free legal consultation and to find out if you are eligible to file a lawsuit, contact our law firm by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form.