Massachusetts Bans Sale of Powerful Prescription Painkiller Zohydro

Officials in Massachusetts agreed to block the sale of the controversial, but FDA-approved, prescription painkiller, Zohydro.

Governor Deval Patrick announced the ban on the prescription painkiller on Thursday, March 27th, and formally declared prescription painkiller abuse and overdose a public health emergency in New England.

Zohydro’s manufacturer, Zogenix, said in a statement on Thursday that the state’s ban “only serves to unfairly restrict patient access,” and that “the ban on the prescription medication will add to patient suffering in the state.”

The company pointed out that Zohydro, unlike its leading competitors Vicodin and Lortab, does not contain acetaminophen, which is often added to opioid painkillers to help control pain. However, acetaminophen can cause allergic reactions and liver damage, so in theory Zohydro could be a good alternative to other painkillers because it would not damage the liver as much.

Proponents of the prescription painkiller say that allowing Zohydro onto the market will help people that suffer from chronic pain. By having access to a potent opioid, chronic pain sufferers can take smaller doses or have alternatives when some types of pain medication don’t work.

However, public objections to the FDA approval of Zohydro have not centered on the active ingredients, but on the rapidly-growing epidemic of prescription painkiller abuse in the US.

“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg. “Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

“Once/if the Purdue product is approved, possibly in 2015, FDA could then rule that Zohydro is not as safe as the abuse-deterrent product and either pull the drug’s approval or ask Zogenix to withdraw it voluntarily,” Rob Cox, an analyst with Capital Alpha Partners, said earlier this week.

FDA Chief Defends Zohydro Despite Public and Lawmaker Concerns

In the face of the new potential legislation, FDA Commissioner Dr. Margaret Hamburg defended the FDA’s choice to approve Zohydro.

Dr. Hamburg told Senators that the painkiller fills an “important and unique niche” to treat chronic pain.  She said that, because the drug is just hydrocodone and nothing else, there is much less potential for liver failure related to taking the pain medication. Other opioid pain painkillers, when taken regularly at high doses, increase the risk of liver toxicity or failure as a side effect.

Hamburg added that tamper-resistant ingredients are also in the early stages of development. To date, the agency has only approved one medication with such features – OxyContin, a strong but popular opioid painkiller prescribed to treat a variety of chronic pain.

“It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor,” Hamburg said.

The Strom Law Firm Can Help with Charges of Prescription Painkiller Abuse

If you have received criminal drug abuse charges, or are suspected of abusing prescription painkillers, you are not automatically guilty, and you do not give up any of your rights. The attorneys at the Strom Law Firm can help defend you. We offer free, confidential consultations to discuss the facts of your case. Do not let criminal drug charges such as trafficking or possession ruin your reputation and career prospects. Contact us today. 803.252.4800.