Wednesday, September 10, 2014

New England Governors Call on Federal Government to Rescind Zohydro Approval
September 9th, 2014/

The governors of five New England states have asked the U.S. Department of Health and Human Services (HHS) to rescind approval of Zohydro ER, a pure form of the opioid hydrocodone.

The governors of Massachusetts, Vermont, New Hampshire, Rhode Island and Connecticut said in a letter to HHS Secretary Sylvia Mathews Burwell that Zohydro should be removed from the market because of an epidemic of opioid addiction in their states, The Wall Street Journal reports.

The Food and Drug Administration (FDA) approved Zohydro ER in October 2013 for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other medications. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high.

The governors noted Zohydro’s manufacturer, Zogenix, plans to seek approval to sell a version of the drug with abuse-deterrent features.

“As our federal partner, we urge you to overturn the FDA’s erroneous decision,” the governors wrote. “The likelihood of abuse, as well as the anticipated availability of an alternative [drug] are reasonable grounds for the FDA to rescind its approval. Our states do not need another high risk drug that will only contribute to the current epidemic of prescription drug abuse.”

In March, Massachusetts Governor Deval Patrick tried to ban Zohydro in his state. A federal judge ruled the state cannot ban the drug. In April, Vermont Governor Peter Shumlinannounced an emergency order to make it more difficult for doctors to prescribe the drug.

No comments:

Post a Comment