The U.S. Food and Drug Administration is facing a backlash over a painkiller it approved last year and is now set to go on sale in pharmacies next month.In a petition from dozens of anti-addiction groups to the FDA, the groups are call the newly approved drug, Zohydro, the next OxyContin.
| As deaths from heroin and powerful painkillers skyrocket nationwide, governments and clinics are working to put a drug that can reverse an opiate overdose into the hands of more paramedics, police officers and the people .
Supporters say the opportunity to save potentially thousands of lives outweighs any fears by critics that the promise of a nearby antidote would only encourage drug abuse.
The drug has recently begun to be carried by Buffalo Police, as overdoses rise locally.
Among them is New Jersey, which passed a law last year that allows members of the public to carry naloxone - administered through a nasal spray or injection into a muscle - after getting training.
About 20 people, most of them related to overdose victims or people who currently abuse heroin, crowded into a clinic last weekend in Camden, a drug-plagued city across the Delaware River from Philadelphia, to learn about the antidote. Jane Stiuv, whose daughter survived a heroin overdose in 2011, listened as a nurse described the signs of an overdose and when to administer naloxone.
Stiuv, who found her daughter slumped over the side of a bathtub with a needle in her arm hours after her release from prison, said she wanted to learn how to reverse an overdose should it happen again. Each attendee received a kit containing two syringes, a small vial of naloxone, alcohol swabs and a face shield for rescue breathing.
Naloxone is regarded within the medical community as highly effective when used properly. A study conducted during a state-supported pilot of naloxone distribution and overdose education in Massachusetts showed it was 98 percent effective in attempts to rescue a person who overdosed.
Police in Quincy, Mass., have been carrying naloxone nasal spray since 2010 and said in July 2013 that they used naloxone 179 times, reversing 170 of those overdoses - a 95 percent success rate.
According to the White House Office of National Drug Control Policy, the number of overdose deaths involving prescription drugs increased 21 percent from 2006 to 2010; the number of overdose deaths involving heroin increased 45 percent.
Bills are pending in at least seven states to increase access to naloxone. In Tennessee and Utah, doctors would be allowed to prescribe it, and civil liability for those who administer it would be dropped. A Wisconsin bill seeks to broaden access to naloxone and, as New Jersey also does, provide legal immunity to drug users reporting an overdose.
The White House drug policy office is also urging all first responders to have naloxone on hand. In 2012, the Food and Drug Administration held hearings on making naloxone available over the counter, but it has not yet done so.
But not everyone is sold on the idea of making it more widely available.
In Maine, where heroin overdoses increased fourfold from 2011 to 2012, Gov. Paul LePage opposes a bill that would allow health care professionals to prescribe it and allow more emergency responders to carry the drug.
LePage, who wants to add 14 new drug enforcement agents in the state, cites concerns that it would raise Medicaid costs. He also has said the drug provides "a false sense of security that abusers are somehow safe from overdose if they have a prescription nearby."
An overdose of opiates essentially makes the body forget to breathe. Naloxone works by blocking the brain receptors that opiates latch onto and helping the body "remember" to take in air. The antidote's effects wear off in about a half hour, and multiple doses may be needed.
The drug's backers say it's crucial to train relatives or friends of addicts because the person overdosing is likely sick or unconscious and unable to self-administer the antidote. It also must be given within a certain window; most overdoses occur within a half-hour to three hours after injecting too much of a drug.
The effort includes Avi Israel of Williamsville, who became the local face of a campaign against Painkiller abuse, after he lost his son Michael to suicide as part of an addiction to pain killer medications.
Israel is one of several who signed a local letter to the FDA in protest, and the local advocates are one of several groups nationwide mobilizing against the drug,
"This is a dangerous pill. If a person makes a mistake and takes two pills at the same time, you are not waking up again," Israel said.
They are warning the FDA that, if the drug is released to pharmacies as scheduled early next month, it will lead to more drug addiction and more drug-related death.
"In my opinion it's going to take a few people dying before the FDA changes their mind," Israel said.
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Last October, the FDA approved Zohydro for patients who suffer "pain severe enough to require daily, around-the-clock, long-term treatment."
But the power of a drug like this is the issue. Zohydro is essentially pure hydrocodone, a painkiller similar to OxyContin, and would be given to patients in doses between 10 and 50 milligrams a day - that's up to 10 times the typical dose of hydrocodone now.
One of the physicians asking the FDA to revoke its approval is Dr. Andrew Kolodny. He is the chief medical officer of Phoenix House, a clinic that treats patients for drug addiction. He said, "This is a product that's dangerous even to people who are trying to use it as directed."
Kolodny continued, "Many people are concerned that, as soon as this drug hits the market, many people will die from it. A child who's never taken an opioid before could die from taking just one capsule, and an adult who's not used to taking opioids could overdose on just two capsules."
Supporters of the drug call it essential for patients who suffer non-stop pain from cancer, back problems or arthritis and who don't benefit from less-powerful painkillers. In a statement, Zogenix, the drug's maker, called the drug a "new treatment option" for those patients and said the company was "committed to promoting the appropriate prescribing and use of Zohydro."
Still, FDA approval of the drug was unexpected and some say unprecedented.
In 2012, an FDA advisory panel voted 11-2 against Zohydro, with most of the experts fearing the drug - like OxyContin - would lead to abuse and become a threat to public health.
The FDA told CBS News in a statement that it approved Zohydro because so many patients need it and because "the product's benefits outweigh its risks when used as ... approved." But that's the heart of the controversy, CBS News' Wyatt Andrews reported: Can a drug this powerful can be kept in the box and only be used as approved?
Addiction to prescription painkillers, especially among young adults, is growing at an alarming rate in Western New York. In order to address this epidemic, BlueCross BlueShield of Western New York has formed a community outreach initiative to increase public awareness of prescription painkiller addiction, provide educational resources to schools, students, parents and community groups, and most importantly, to connect those in need with appropriate treatment resources.
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Forty Four percent of all teens say they have a friend or know someone struggling with painkiller abuse and addicition. Across the nation, one person dies from opiate abuse every 19 minutes
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