Dangers of Zohydro causing concerns in West Virginia

Last updated: March 14. 2014 11:17AM - 1270 Views
Fred Pace fpace@civitasmedia.com

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According to a 2013 report from the Trust of America’s Health, West Virginia has the highest drug overdose mortality rate in the United States, an increase of 605 percent since 1999.

In McDowell County alone, 12 people die from prescription drugs every month, according to the report.

In 2011, Boone County ranked second among West Virginia’s 55 counties in prescription drug abuse.

“These are not just statistics – they are parents, children, friends, family members and lives torn apart,” Tennant wrote.

Now, a potentially deadly new prescription painkiller, known as Zohydro, is scheduled for release soon by the U.S. Food and Drug Administration (FDA).

West Virginia Secretary of State Natalie Tennant and U.S. Senator Joe Manchin (D-W.Va.) called on the FDA to halt the release of Zohydro.

Secretary Tennant invited the FDA to come to West Virginia and answer to local families who have lost loved ones to prescription drug addiction before releasing Zohydro on the market.

“West Virginians are working hard to combat the prescription drug epidemic. Introducing a dangerous and potentially deadly new drug into the market flies in the face of their efforts,” Secretary Tennant wrote. “I ask you, please, work with us, not against us. Come to West Virginia and see the consequences of prescription drug abuse for yourself. Look in the eyes of families who have lost loved ones, and hear their stories. Honor the FDA mission to protect the public health and halt the release of Zohydro.”

In December 2012 the FDA’s own advisory council voted 11-2, against recommending Zohydro, citing a high risk for abuse and addiction. Despite this, the FDA approved Zohydro in October 2013 against the recommendation of public officials, advocates, law enforcement and medical personnel.

Zohydro was scheduled for release at the beginning of March.

In her letter to FDA Commissioner Margaret Hamburg, Secretary Tennant highlighted the dangerous potential of Zohydro, which is five to ten times more potent than painkillers currently available to the public, and can be easily crushed and snorted.

Secretary Tennant also cited questions raised recently by West Virginia U.S. Senator Joe Manchin over so-called ‘pay-to-play’ circumstances surrounding the approval of Zohydro. Senator Manchin has requested additional information from the FDA, and Tennant said Zohydro should not be released before all parties involved comply with Manchin’s request for information.

Manchin sent a letter to the U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius to overturn the Federal Drug Administration’s (FDA) approval of the powerful and highly addictive opioid drug, Zohydro Extended Release (ER).

Senator Manchin expressed his concerns with FDA’s approval given that the FDA’s own expert advisory panel voted against the approval of Zohydro ER by a vote of 11-2 and health experts have repeatedly warned of the potential increase in prescription drug abuse if this highly addictive painkiller becomes publicly accessible.

Manchin urged Sebelius to act as swiftly as possible to keep this dangerous drug off the market.

Meanwhile, other West Virginia leaders are asking government officials to do more to help in the battle against prescription drug abuse.

Attorney General Patrick Morrisey said his office sent a letter to Michele Leonhart, Administrator of the Drug Enforcement Administration, supporting the agency’s rescheduling of hydrocodone combination products from Schedule III to Schedule II.

As a Schedule II drug, hydrocodone combination products, such as painkillers Lortab and Vicodin, would be harder to prescribe.

According to the Controlled Substance Act, Schedule II drugs usually require handwritten prescriptions with no refills as well as other restrictions. Schedule III drugs, on the other hand, may be written or called in to a pharmacy and be refilled five times within six months.

Drugs that are classified as Schedule II are defined as drugs that have a medical use but also have a high potential for abuse and dependency. Schedule II drugs are considered more dangerous than Schedule III drugs.

“We believe this will represent another small step in combating the prescription drug epidemic in our state,” Attorney General Morrisey said. “Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl.

“Sadly, we’re painfully aware of the consequences of the drug epidemic in this state, and especially hydrocodone abuse,” Morrisey said. “I hope the DEA acts as quickly as possible with this rulemaking so West Virginia will be able to have more tools to help combat this serious and devastating epidemic. This is a serious problem, and it demands urgent action.”

Last month, Morrisey announced that his office will partner with local law enforcement agencies across the state to expand access to secure disposal locations for unwanted or expired prescription drugs.

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