Oxy Watchdog

Keeping An Eye On OxyContin

Posts Tagged ‘FDA’

New brand of prescription painkiller oxycodone approved

Posted by Oxy Watchdog on October 23, 2010

A new form of oxycodone hydrochloride, a synthetic opiate like the brand name drug OxyContin, was approved by the U.S. Food and Drug Administration this week, reports this release from the FDA. Lehigh Valley Technologies formulated the brand-name Oxycodone HCI as a morphine-derived painkiller to rival Purdue Pharma’s best-selling brand OxyContin. Purdue has tried to limit production of time-release and generic brands of oxycodone and has been embroiled in several lawsuits to maintain control of its $3 billion-per-year drug. According to its website, Lehigh Valley has developed its own version of abuse-deterrent drugs. In 2009, Lehigh Valley received a warning from the FDA for marketing an unapproved version of morphine, as detailed in this letter from the FDA. Like the brand-name OxyContin, Oxycodone HCI is a Schedule II narcotic and highly prone to addiction.

Read more about Purdue’s suppression of generic forms of oxycodone here.

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New drug for Oxy, heroin addiction approved by FDA

Posted by Oxy Watchdog on October 18, 2010

A new treatment for opioid addiction – which includes heroin and painkillers like OxyContin and Vicodin – was approved by the U.S. Food and Drug Administration earlier this week, according to this article in USA Today. Unlike existing treatments which are essentially low-dose versions of the drug, Vivitrol is a once-monthly injection that blocks the effects of opiate drugs and is non-addictive. Though Vivitrol will sell for about $1,100 per injection, the creators are developing an implant that will last for six months, reports this article in the Washington Post. The article also cites a study by the National Institute on Drug Abuse which found that about 810,000 Americans are addicted to heroin and another 1.85 million to opioid painkillers such as OxyContin.

Read about the drug buprenorphine used in opioid addiction treatment here.

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Pfizer snaps up maker of less-abusable OxyContin

Posted by Oxy Watchdog on October 12, 2010

King Pharmaceuticals, the maker of oxycodone-containing painkillers Remoxy and Acurox, has been bought by Pfizer for $3.6 billion, according to this article in the Washington Post. Remoxy was designed to be an abuse-resistant, control-released form of the opioid painkiller OxyContin, but was rejected by the U.S. Food and Drug Administration in 2008, reports this article from The Street. King also developed Acurox, another abuse-resistant opioid painkiller set to be submitted to the FDA in 2011. According to the Washington Post, with Pfizer at the helm, sales of the drugs could reach $500 million per year. Purdue Pharma, makers of OxyContin, are also developing a less-abusable version of their $3 billion per-year painkiller.

Read about Purdue’s less-abusable version of OxyContin here.

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Watchdog Reports: Panel says doctors, Internet main instigator of prescription drug abuse

Posted by Oxy Watchdog on September 24, 2010

Two large bottles of liquid oxycondone proved a powerful visual for the practice of over-prescribing pain medication that leads to or aids in prescription drug abuse at Wednesday’s panel presentation discussing the growing national trend, hosted by Chico State University in California.

The three-hour panel presentation was put together by Not in our Town Glenn County, managed by Jim Bettencourt and attend by 60 students, parents and community members. OxyWatchdog contributor Esmeralda F. Ramirez was there to hear what the panel had to say.

According to Bettencourt, the irresponsibility of doctors prescribing an excess of a drug is not uncommon and many physicians do not screen patients to see what is in their bodies. When a patient in pain is asking for a large amount of Vicodin, for example, the physician should ask for a simple urine test to check for existing medication in the patient’s system and prescribe the necessary amount of drugs, he said.

When patients want more than what they are prescribed, it’s a sign that they have become addicted, said Salvadore Biondolillo of the U.S. Drug Enforcement Agency, which is sponsoring this Saturday’s Take-Back Day. A classic example, he said, is a patient that has been taking hydrocodone, then switches to oxycodone, then OxyContin, and finally to heroin because it is much cheaper than prescription drugs.

A dangerous online world

If someone with an addiction cannot get enough of their prescription drug of choice from a physician, they go online, according to Biondolillo. Websites are one of the reasons prescription drug abuse has been increasing in the past few years, he said: there are sites that contain a multitude of information for many kinds of prescription drugs, and it is difficult to monitor all of them. Biondolillo refers to the Internet as “the perfect storm” because prescriptions that come from overseas are not approved by the U.S. Food and Drug Administration, or are often placebos, he said.

Drugs next door

Another way addicts find prescription drugs is through friends, family or street sells, Biondolillo said. When physicians prescribe a excessive amount of drugs, there are bound to be leftovers, said Lee Snook, medical director of the Metropolitan Pain Management Consultants Inc. There are a lot of cases in which the leftovers are divided and sold on the street or are given for free to friends and family as experimentation, he said.

A generation of young addicts

The best place to discuss and educate the community about the rising problem of prescription drug abuse is in colleges throughout the U.S., according to Susan Foster, vice president and director of policy, research and analysis at the National Center on Addiction and Substance Abuse at Columbia University (CASA). College is where young people start to experiment, she said, and prescription drug abuse on many college campuses is rampant.

One interesting sidenote: a study by CASA found that in the early 1990s, those that used prescription drugs to get high were people who had already been using illicit drugs such as cocaine or heroin, Foster said. In the early- to mid-2000s, however, the study showed that prescription drug abuse was coming from high school and college students, she said. They were experimenting with those drugs, replacing marijuana as the experimentation drug historically common among younger generations.

There are different reasons why people begin abusing illicit drugs and other substances, Foster noted. But when it comes to prescription drugs, advertising – to which young people are particularly susceptible – plays a role because it creates a mindset that everything can be cured with a pill.

“We have to change the culture of this disorder,” Foster said.

Pills as life-threatening as guns

Although the choice is always up to the individual, parents play a big role in helping their children stay away from prescription drugs, according to Snook. Prescription drugs are like guns, he said. They both kill, and they both need to be locked away from children and disposed of properly if they are not needed anymore.

Snook, for his part, tries to help people recover because he himself is a former addict and understands the hardships associated with addiction.

“I see Satan’s eyes in the person I’m trying to save,” Snook said.

By Esmeralda F. Ramirez, exclusive to OxyWatchdog

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Flushing, trashing unused prescription drugs poses environmental threat

Posted by Oxy Watchdog on September 21, 2010

The effects of Saturday’s Prescription Drug Take-Back Day won’t just be felt by people – the environment may also reap the rewards. According to press releases from the Environmental Protection Agency and the U.S. Fish and Wildlife Service, the improper disposal of medications may have adverse effects on the ecosystem. While the Food and Drug Administration recommends flushing unused prescriptions down the toilet to prevent abuse, such practices cause contamination to the nation’s waterways.

According to this report from Illinois-Indiana Sea Grant, flushed drugs kill the bacteria that break down waste in sewage plants, damaging septic systems. In fact, a 2008 Associated Press investigation found pharmaceuticals in the drinking water of at least 41 million Americans in 24 major metropolitan areas, the IISG reports. According to Ecolocalizer.com, some medicines have even been associated with altering the sex characteristics of fish.

During one of the national take-back events this Saturday, once the drugs are handed in to law enforcement personnel  they will likely be incinerated at high temperatures.

Read more about the take-back initiative here.

Find a collection site near you here.

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Purdue to pay $16 million for suppressing generic brands of OxyContin

Posted by Oxy Watchdog on September 8, 2010

Purdue Pharma, manufacturer of prescription pain pill OxyContin, will pay $16 million to direct purchasers of the drug who claim Purdue obtained patents through misleading information, according to this article in the Wall Street Journal. Since the patents were filed in the 1990s, purchasers of the drug accused the pharmaceutical company of using invalid patents to sue companies making generic versions of OxyContin, thereby delaying the FDA approval process for those generics, reports Law 360. Purdue has already settled the majority of 57 similar cases.

Read about other cases against Purdue from makers of generic OxyContin here.

Posted in Litigation, Pharmaceutical Industry | Tagged: , , , | 1 Comment »

Ind. opiate abuse increasing faster than national average

Posted by Oxy Watchdog on August 29, 2010

According to figures released by the Centers for Disease Control and Prevention, fatal overdoses of opiates – including OxyContin – outnumber those caused by other drugs. In Indiana, the Journal Gazette reports that compared to the national average, the abuse of prescription drugs is climbing higher faster than that of illegal drugs. In 2008, the use of OxyContin alone had increased by a whopping 712 percent in the state. One major cause for the change, according to the paper: unlike “street drugs” such as cocaine and marijuana which are smuggled in from other countries, prescription narcotics are readily available at local pharmacies. The abuse is also being fueled by the perception that because drugs like Oxy are prescription medicines and approved by the U.S. Food and Drug Administration, they are safer than illegal drugs, the paper says.

To read about the national trend of increased prescription drug abuse, go here.

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FDA OKs less-abusable Oxy

Posted by Oxy Watchdog on April 6, 2010

The U.S. Food and Drug Administration has approved a new formulation of controlled-release OxyContin that is intended to make the powerful painkiller harder to abuse. The new formulation will most likely result in less abuse by inhaling or injection, but can still be abused or misused by ingesting larger doses than are recommended, the agency said.

Purdue Pharma LP, OxyContin’s maker, admits that “there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction.”

Posted in Pharmaceutical Industry, Policy & Regulation | Tagged: , , , , | 3 Comments »

FDA unveils new prescription drug abuse stats

Posted by Oxy Watchdog on November 4, 2009

 In 2007, 5.2 million Americans 12 years and older reported using a 
prescription pain reliever for a non‐medical use in the last month— resulting in more than 165,000 emergency department visits related to non-medical use of hydrocodone, oxycodone, and methadone-containing products alone, according to new statistics just released by the U.S. Food and Drug Administration.

Per the FDA: “Today, tens of millions of people in the United States depend on prescription and [over-the-counter] medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, and some die as a result of preventable medication errors..many of these medication-related risks are manageable if parties committed to the safe use of medications work together.”

Read more about the FDA’s Safe Use Initiative here.

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FDA panel, with concerns, backs “tamper-resistant” Oxy

Posted by Oxy Watchdog on October 5, 2009

pillsoverdoseA panel of the U.S. Food and Drug Administration has thrown its weight behind Purdue Pharma’s latest version of OxyContin, which the drug maker says is reformulated with a plastic-like coating that makes it harder to crush and snort or inject. But the panel – which voted 14-4 in favor of greenlighting the company’s application – also recommended Purdue be required to conduct a follow-up study of whether the drug is actually less likely to be abused. The Wall Street Journal reports that several panel members said they gave their approval only because voting the application down would keep the current easy-to-tamper-with OxyContin on the market.

Purdue says it won’t market the drug as more resistant to tampering, but critics have been expressing concerns since last year that the new formulation will be perceived as safer even if that’s not necessarily the case.

Did Purdue learn its lesson after being slapped with a $635 million fine over its past marketing antics? Stay tuned.

One final note: Watchdog speculates that “tamper-resistant,” let alone “tamper-proof,” is ultimately a pipe dream when it comes to drugs like OxyContin. Never underestimate the power of human ingenuity.

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