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FDA ignored expert objections and its own advisory panel and approved deadly new painkiller

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(NaturalNews) Over the objections of its own advisory panel, the FDA has approved another killer drug which hit pharmacy shelves in March - a powerful new painkiller named Zohydro which is 10 times stronger than Vicodin. In approving the drug, the FDA ignored an overwhelming 11 to 2 vote against approval by the advisory panel and dire warnings and objections from state attorneys general and a coalition of health care, consumer and addiction treatment groups.

Zohydro set to become the king of the opiods

Zohydro is a super concentrated time-release opioid. Despite being packaged in time-released form, experts warn that the potential for abuse is huge, since the drug can easily be crushed and then either snorted or dissolved and injected.

The new drug belongs to a family of medicines known as opioids because they mimic the active ingredient found in the opium poppy plant. Others opioids include morphine, oxycodone, codeine and methadone.

The FDA approved Zohydro in October, making it the first single-ingredient hydrocodone drug ever cleared for U.S. patients. The pill uses an extended release formulation that is reportedly five to 10 times more potent than currently available hydrocodone combination pills, such as Vicodin. The approval surprised many doctors, coming after the FDA advisory panel previously voted overwhelmingly against the drug, citing its potential for abuse.

The FDA and San Diego-based Zogenix, who makes Zohydro, justified the drug by maintaining that it is needed to help patients who are unable to find enough relief from current medications. However, doctors and other experts have warned that the risks do not outweigh the benefits, noting that the new drug is so strong that only two capsules could be fatal for an adult and a single capsule could kill a child.

Objections to approval of Zohydro

Attorneys general from 28 states plus the territory of Guam have written the FDA objecting to the new drug and a coalition of more than 40 health care, consumer and addiction treatment groups sent a letter to the FDA warning that the release of the drug will result in dire consequences.

"In the midst of a severe drug epidemic fueled by over-prescribing 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."

One addiction expert who signed the letter was even more explicit in his warning.

"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."

The use and deadly abuse of opioids in the U.S.

Hydrocodone is the most prescribed medicine in the country, with more than 131 million prescriptions having been written in 2011. Hydrocodone is also consistently ranked among the most-abused medicines in the U.S., according to the Drug Enforcement Administration. Data from the International Narcotics Control Board found Americans consume more than 99 percent of the world's supply of hydrocodone supply. The U.S. also consumes 84 percent of the world stock of oxycodone.

According to data from the Centers for Disease Control and Prevention (CDC), drug overdose was responsible for 38,329 deaths in the US in 2010, having increased 11 successive years. In 2010 and for the third year in a row, the number of US citizens whose deaths were drug related exceeded the number of auto fatalities (32,885). Opioid overdoses have claimed 125,000 US lives in the last decade.

Sources for this article include:




About the author:
"See more articles by Tony Isaacs"

Tony Isaacs, is a natural health author, advocate and researcher who hosts
The Best Years in Life website for those who wish to avoid prescription drugs and mainstream managed illness and live longer, healthier and happier lives naturally. Mr. Isaacs is the author of books and articles about natural health, longevity and beating cancer including "Cancer's Natural Enemy" and is working on a major book project due to be published later this year.

Mr. Isaacs also hosts the Yahoo Oleandersoup group of over 3000 members and the The Best Years in Life Radio Show" on BlogTalk Radio.

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