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New drug raises concerns

By Ashley B. Craig, Police Reporter

CHARLESTON, W.Va. -- A new prescription painkiller is causing some concern among law enforcement before it has even hit the shelves in West Virginia.

It’s called Zohydro, a new product from the San Diego-based pharmaceutical company Zogenix. The drug is hydrocodone without acetaminophen, the ingredient that leads to liver damage with extended use.

The drug won approval from the Food and Drug Administration in October but has yet to hit the market. Critics, including Massachusetts Gov. Deval Patrick, who tried to ban the drug outright in his state, and Sen. Joe Manchin, D-W.Va., who introduced a bill in the Senate to ban the drug, claim it will add to the prescription pill epidemic.

Charleston Lt. Eric Johnson, commander of the Metro Drug Unit, has the same concern.

Johnson admits he’s still learning about the medication, but said he and other officers have “serious concerns.”

“It all depends on how it’s prescribed and to whom and what quantities, and that is on the medical community,” he said.

He was under the impression that the drug was similar to the original Oxycontin pills. The drug is said to be a time-release pain reliever, but he said even that was something an addict could easily overcome.

“There’s definitely the potential for severe abuse on these,” Johnson said.

A study released last year by the Trust for America’s Health, a D.C.-based health policy organization, showed West Virginia had the highest drug overdose rate in the country.

“The number of drug overdose deaths — a majority of which are from prescription drugs — increased in West Virginia by 605 percent since 1999 when the rate was 4.1 per 100,000,” the organization said in a statement.

“Nationally, rates have doubled in 29 states since 1999, quadrupled in four of these states and tripled in 10 more.”

Patrick told the Associated Press Tuesday he was disappointed after a federal judge ruled that the state could not ban the drug. The ruling came after Zogenix filed a lawsuit claiming the ban was unconstitutional.

“Today’s legal ruling was a positive step forward for Massachusetts patients,” Roger Hawley, chief executive officer of Zogenix, said in a statement on the company’s website. “We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment.”

Patrick said the ruling placed commercial interests above public health.

“Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn’t tamper proof,” Patrick said in a statement. “We will turn our attention now to other means to address this public health crisis.”

The FDA approved the drug even though the administration’s Anesthetic and Analgesic Drug Products Advisory Committee voted 11 to 2 against moving the drug forward in the approval process.

Manchin sent letters to the FDA and to Kathleen Sebelius, former Secretary of Health and Human Services, with his concerns about the authorization process of “highly addictive drugs, including the approval of Zohydro,” according to a statement regarding the drug on his website.

“Because of this painkiller’s high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country,” Manchin said in a statement last month. “The prescription drug abuse epidemic has already damaged and destroyed the lives of far too many individuals and families, and hydrocodone is one of the most abused substances out there.

“The last thing we need is a drug on the market with 10 times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual in just two tablets.”

Zogenix maintains that in terms of hydrocodone potency, a 10-milligram dose of Zohydro is the same potency as a 10-milligram dose of Vicodin.

“There are also many marketed opioids that are more potent than hydrocodone such as oxymorphone, methadone, hydromorphone and fentanyl,” the company said in an April 2 statement titled “Let’s get the facts straight about Zohydro ER.”

The drug is aimed at patients in severe chronic pain needing daily long-term relief.

It was set to be released early this year, but it wasn’t clear when the drug would hit pharmacy shelves.

Contact writer Ashley B. Craig at ashley.craig@dailymailwv.com or 304-348-4850.

New drug raises concerns


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