FDA Approved Prescription Painkiller Described as “Genuinely Frightening”

The FDA recently reclassified hydrocodone-based prescription painkillers from Schedule III to Schedule II – a classification that would mean patients would have to revisit their doctor every time they needed a refill. This change in classification would, hopefully, help prevent prescription painkiller abuse, a drug epidemic sweeping the nation.

However, the FDA also recently approved an incredibly strong prescription painkiller – Zohydro, which critics worry is so strong it could negate any headway made in the war against prescription painkiller abuse.

“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.”

“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”

Zohydro was approved for use as a prescription painkiller last fall, and is expected to reach the US drug market in March.

The drug was also approved despite a December 2013 letter signed by 29 attorneys general in various states, asking the FDA to review its decision. The month before, Congress also asked the FDA to review the approval.

The FDA has not done any review on the prescription painkiller’s approval.

“This could be the next OxyContin,” says a petition, asking the FDA to reconsider. OxyContin and oxycodone drugs are the most abused prescription painkillers on the market today.

“You’re talking about a drug that’s somewhere in the neighborhood of five times more potent than what we’re dealing with now,” said Dr. Stephen Anderson, a Washington emergency room physician who is not part of the most recent petition to the FDA about the drug. “I’m five times more concerned, solely based on potency.”

However, advocates for better treatment of chronic pain are less concerned with Zohydro’s potential addictiveness.

“We know that a person with pain is not a person who abuses medications,” said Paul Gileno, founder and president of the U.S. Pain Foundation, a group that receives some funding in unrestricted grants from the pharmaceutical industry. “A person with pain is a person suffering to get pain relief in order to live a fulfilling life.”

The prescription painkiller’s manufacturer, Zogenix, cited several examples of those with chronic pain who might benefit: a woman with metastatic breast cancer who suffers diffuse pain, a man with chronic leg and back pain that remained uncorrected by surgery, and a woman with multiple orthopedic fractures.

While prescription painkillers are usually prescribed with good intentions, the fact that so many people suffer chronic pain has allowed drug addicts to easily find a quick fix. Prescription painkillers can be stolen off those who genuinely need them, or addicts can “doctor shop,” receiving multiple prescriptions to treat their chronic pain.

Some states have created strict databases to monitor patients’ prescriptions, in an attempt to stem prescription painkiller abuse. Other states carefully monitor doctors’ prescriptions, charging “pill mills” for profiting from drug addiction.

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.