SHAHEEN RAISES CONCERNS ABOUT POWERFUL NEW PAINKILLER WITH FDA, ASKS FOR REVIEW AND SURVEILLANCE

(Washington, DC) – As part of her ongoing efforts to help combat New Hampshire’s heroin and prescription drug public health crisis, U.S. Senator Jeanne Shaheen (D-NH) sent a letter today to the Food and Drug Administration (FDA) raising concerns over a recently approved, controversial and potent narcotic – Zohydro ER (hydrocodone bitartrate)—that has been banned or limited in some states. 

In a letter to FDA Commissioner Margaret Hamburg, M.D., Shaheen said she is “concerned that Zohydro will contribute to the ongoing epidemic of opioid drug abuse and overdose,” which killed more than 22,000 Americans in 2011, according to the Centers for Disease Control (CDC).

Zohydro, which the FDA approved last fall, is an extended-release hydrocodone tablet that belongs to the family of medicines known as “opiates” or “opioids,” which includes morphine, heroin and oxycodone, the painkiller in OxyContin. Since the drug, which can contain up to five times the amount of narcotic hydrocodone previously available in pills, became available on the market last month, numerous law enforcement and public health officials have expressed worry that the potent Zohydro could lead to more drug addiction and more drug-related death.

“I believe that there is a public health risk from Zohydro and ask that you review the approval of doses of Zohydro greater than any existing available dose for hydrocodone containing compounds,” Shaheen said, asking the FDA commissioner to implement a detailed post-market surveillance program that closely monitors and documents all cases of Zohydro abuse and overdose. 

Shaheen continued,  “I do not believe we need to add to our existing problems, but rather, we need to appropriately monitor the currently available narcotic prescriptions, provide treatment for individuals suffering from addiction, and help law enforcement prosecute those who illegally procure and sell opioid prescription drugs.”

The letter sent today is the most recent effort by Shaheen to fight New Hampshire’s growing heroin and prescription opioid abuse epidemic. Last week, Shaheen convened a roundtable with top law enforcement and public health officials in New Hampshire to identify ways federal, state, and local officials can partner to address the issue and she plans to hold similar forums. Shaheen has also urged U.S. Attorney General Eric Holder to partner and collaborate with state and local law enforcement to comprehensively prevent and address heroin and prescription drug addiction within New Hampshire communities and has called on Senate Appropriations Committee leadership to direct sufficient federal investments to support New Hampshire law enforcement and public health officials to end the drug abuse epidemic.

The full text of Senator Shaheen’s letter is here and below.

April 11, 2014

Commissioner Margaret Hamburg, M.D.
The Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg:

I write to express my concern about the Food and Drug Administration’s October 2013 approval of Zohydro ER (hydrocodone bitartrate). The FDA approved this potent narcotic despite its own advisory panel’s warnings that Zohydro lacked any deterrent against abuse and that it would “be associated with higher levels of abuse than hydrocodone combination products.”

As you know, prescription narcotic drugs are the number one cause of overdose deaths in the United States. In 2011, the Centers for Disease Control (CDC) reported that over 22,000 Americans died of prescription drug related overdoses. Among these prescriptions, narcotic prescriptions killed more Americans than benzodiazepines, anti-depressants, and other sedatives combined.

In 2011, the New Hampshire Center for Excellence, a public-private initiative of the New Hampshire Bureau of Drug and Alcohol Services and the New Hampshire Charitable Foundation, reported that there were 200 prescription drug related overdose deaths. Eighty percent of these overdose deaths were related to opioid pain relievers.

I am concerned that Zohydro will contribute to the ongoing epidemic of opioid drug abuse and overdose. In a recent decision, citing overdose risks, the FDA withdrew approval for products containing higher doses of acetaminophen. Similarly, I believe that there is a public health risk from Zohydro and ask that you review the approval of doses of Zohydro greater than any existing available dose for hydrocodone containing compounds. Further, if Zohydro is brought to market, I ask that you require a detailed post-market surveillance program that closely monitors and documents all cases of Zohydro abuse and overdose.

I do not believe we need to add to our existing problems, but rather, we need to appropriately monitor the currently available narcotic prescriptions, provide treatment for individuals suffering from addiction, and help law enforcement prosecute those who illegally procure and sell opioid prescription drugs.

I urge you to address the safety concerns surrounding Zohydro ER and to take the appropriate action to limit any potential abuse. 

Sincerely,

Jeanne Shaheen

United States Senator