Consumers Lead Fight Against Release of New Opioid, Ask FDA for Backup

Tired of waiting for regulatory changes, consumer groups are now desperately begging the Food and Drug Administration (FDA) to think again before the release of the latest gateway drug to heroin addiction, opioids.  Forty-two advocates have submitted a letter to Dr. Margaret Hamburg of the FDA, begging the FDA to rethink its decision to approve the new drug, Zohydro™ ER (Zohydro). Twenty-nine attorneys general have also submitted a request urging the FDA against releasing Zohydro.

The drug is hydrocodone-based and belongs to a long line of painkillers called opioid analgesics. Last fall, the FDA approved the drug to treat chronic pain, and it is set to become available to patients in March. But as the heroin epidemic reaches new proportions, the thought of adding a newer, stronger drug to the list is harrowing for many. Zohydro is described as being 5 to 10 times stronger than Vicodin, and is so strong experts argue, that someone could die of an overdose in just two pills. A child could die from just one.

Because opioids are prescribed by physicians, people often assume they are safer than illicit drugs. But when these drugs are not taken in the way that they were prescribed or by the individual for whom they were prescribed, there are harsh consequences. Problems such as addiction, overdose and even death may result.

Zogenix, Inc., a pharmaceutical company responsible for marketing the drug, maintains that Zohydro “would allow appropriate DEA registered physicians to treat chronic pain patients using hydrocodone for moderate to severe pain while avoiding acetaminophen-related liver injury.” On October 25, 2013, the FDA approved Zohydro ER as a schedule II controlled substance as the first approved single entity and extended release hydrocodone product.

On February 26, National Public Radio (NPR) hosted a discussion on the dangerous outcomes expected from the drug’s release. Laura Sullivan, an NPR reporter, noted that overdose deaths and addiction rates from prescription painkillers similar to Zohydro have grown dramatically in recent years. Sullivan added that 42 health care advocates are asking the FDA to remove its approval of the drug. She noted that Zohydro is a crushable pill, which means it is also snortable and therefore, more prone to abuse than other drugs such as the newer versions of Oxycontin.

But Dr. Brad Galer, Zogenix’s chief medical officer maintains there’s a lot of misinformation being disseminated by people who don’t have all the facts. According to Galer, Zogenix will introduce a non-crushable version of Zohydro within the next three years. Galer says the company will closely monitor any prescription transfer abuse, but argues that millions legitimately need the drug.

According to the National Institute on Drug Abuse, prescription opioid pain medications such as Oxycontin® and Vicodin® may open the door to heroin abuse.  The Institute reports that nearly half of all young people who inject heroin reported abusing prescription opiods before starting to use heroin. Many individuals reported switching from opioids to heroin because it is cheaper and easier to obtain.

Some pharmacies are already indicating that they will refuse to carry the drug. One Pennsylvania chain is advertising tits refusal to carry the drug. In an interview, pharmacist Brent Ronan says he doesn’t see the need for  another powerful pain narcotic, commenting that “the benefits don’t necessarily outweigh the risks, there’s plenty of options as far as pain relief.”

“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 its letter to Dr. Margaret Hamburg, the FDA commissioner. “Too many people have already become addicted to similar opiod 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.”