DALLAS, Texas (CBSDFW.COM) – A powerful new opiate has been approved by the FDA and will hit the market next month, but some Doctors are already sounding the addiction alarm.
Zohydro ER (extended release) is said to be the purest form of hydrocodone and is estimated to be five to ten times stronger than anything currently on the market. But what makes this drug different from other opiates is that it doesn’t contain acetaminophen.
Mark Feehery CEO of Memorial Hermann Prevention and Recovery Center says the potential for overdose with only two pills of Zohydro ER is greater than with any other opiate based drug.
“Unlike other forms of hydrocodone or oxycontin, this drug has no acetaminophen (Tylenol) so it is in it’s purest form” says Feehery “The idea behind it is that acetaminophen is not good for your liver – which some think makes it not as harmful to you. The reality is that it will be easier to abuse. It’s another opioid being added to the painkiller market that we do not need.”
Despite a vote of 11 to 2 by an FDA panel to reject the powerful new drug, it was eventually given approval by the FDA for release.
Both Zohydro’s maker, Zogenix, and the FDA assert the drug’s benefits outweigh its risks.
“We do not expect the introduction of Zohydro ER to increase the overall use of opioids,” said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, in an e-mail to media outlets. “In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market.”
Feehery’s main concern for the strong new drug is the potential for abuse that can possibly lead to death.
“There are more deaths from prescription pain relievers in this country than from cocaine and heroin combined. The potential for overdose on just two pills is greater with this drug than other opiate-based pain medications” says Feehery.
“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,” a coalition of more than 40 health care, consumer and addiction treatment groups wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.
Galer said Zogenix will focus its commercial efforts on a small group of doctors with good experience prescribing opioids, so that only appropriate chronic pain patients would receive the drug.
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