Tag Archives: Purdue Pharma

FDA OKs controversial form of Vicodin

pills and pill bottlesThe U.S. Food and Drug Administration has approved Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. The move comes amid criticism from those who say the FDA should not be approving any additional opioids given the current prescription drug addiction epidemic. An advisory panel last year voted against approving Zohydro, citing concerns about the danger of addiction posed by the opioid drug class.

Unlike other hydrocodone-containing drugs like Vicodin, Lortab and Norco, Zohydro is not buffered with acetaminophen or some other over-the-counter medication. The drug also lacks an abuse-deterrent feature such as the ones used in new formulations of drugs like OxyContin.

Hydrocodone is currently the second most-abused medicine in the U.S. behind oxycodone.

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Nv. medical board eyes over-prescribing doctors

RXNearly two dozen doctors in Nevada are under investigation by the state’s medical board for allegedly over-prescribing the powerful painkiller OxyContin. The crackdown comes after Sen. Richard “Tick” Segerblom (D-Las Vegas) asked OxyContin maker Purdue Pharma to reveal the names of physicians contained in a database that includes some 1,800 doctors who showed signs of dangerous prescribing.

The Nevada medical board of examiners then met with Purdue and was provided with a list of doctors throughout the state who are suspected of criminal activity, according to this article.

Purdue claims it no longer promotes its product to the doctors at issue, the article says.

The company has taken the stance that the painkiller addiction epidemic was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets, but has admitted that a small number of physicians might account for a “substantial portion” of the nation’s black-market supply of prescription painkillers,

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Lawmakers seek reckless prescribing info from Purdue

DRUG BANNEDIn the wake of a Los Angeles Times report describing a decade-long effort by Purdue Pharma to identify potentially problematic prescribers of OxyContin, two state lawmakers are requesting that the company turn over the names of doctors it suspects recklessly prescribed the pills to drug dealers and addicts.

Sen. Richard “Tick” Segerblom (D-Las Vegas) and California state Sen. Ted Lieu (D-Torrance) want Purdue to reveal the names of physicians contained in a database that includes some 1,800 doctors who showed signs of dangerous prescribing, according to the LA Times.

Purdue has taken the stance that the painkiller addiction epidemic was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets, but has admitted that a small number of physicians might account for a “substantial portion” of the nation’s black-market supply of prescription painkillers, the article says.

According to the article:

Beginning in 2002, Purdue trained its sales representatives to report “red flags” in doctors’ offices, such as young patients, long lines, people nodding off in waiting rooms and frequent cash transactions. Purdue attorneys review their reports, and if a doctor’s practice is deemed too risky, the company bars sales representatives from marketing to the physicians. The suspect doctors are removed from the company’s numbered sales territories and assigned to the database, known as “Region Zero.”

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Staten Island Oxy supply dwindles, opening door to heroin

DRUG BANNEDAs the prescription drug epidemic in New York’s Staten Island gets more attention, addicts and criminals are discovering it increasingly difficult to get doctors here to write new prescriptions for oxycodone, or find pharmacies willing to fill those scripts for new patients, which is pushing people elsewhere to obtain the painkiller, according to this article. An analysis of state health department data showed that in 2012, borough residents received 141,481 prescriptions for the drug; Staten Island physicians were responsible for writing out 110,327 of those prescriptions, meaning at least 31,000 of Islander’s scripts, possibly more, come from off-Island doctors, the article says.

Similarly, pharmacies in the borough filled out 122,048 oxycodone prescriptions in 2012, indicating that residents went off-Island to fill at least 19,400 of their scripts, the article says.

By comparison, Manhattan residents received just 264,271 prescriptions for oxycodone last year, but doctors there wrote out nearly twice as many scripts there — 514,819 in total, according to the article.

And unfortunately, the dwindling supply of pills may start to push people towards other dangerous opiates, according to one treatment director quoted in the article:

Everybody who’s been using for the past 10 years, they aren’t going to stop. They’re going to heroin.

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Generic Opana to remain on the market: FDA

PillsThe U.S. Food and Drug Administration said Friday it will continue to allow sales of the generic version of the painkiller Opana that does not include an abuse-resistant feature.

Opana’s manufacturer, Endo Pharmaceuticals, had submitted a petition to the agency asking it to ban generic forms of the painkiller, which Endo has reformulated as “Opana ER” to make it harder to abuse. That petition was denied by the FDA, which said Endo’s reformulation was not significantly safer than the original version:

While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.

Endo’s petition came after Purdue Pharma successfully asked the FDA to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make it more difficult to crush, break, or dissolve.

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Painkiller market to reach $8.4B by 2017: WSJ

pill money signPrescription painkiller sales are set to increase by 15% and hit $8.4 billion by 2017, due in part to the U.S. Food and Drug Administration’s recent decision to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse. Experts are predicting a race across the pharmaceutical industry to create a market where all opioids have abuse-deterrent properties, according to the Wall Street Journal.

According to the FDA, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”

OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.

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FDA bans copycat versions of original Oxy amid abuse concerns

DRUG BANNEDThe U.S. Food and Drug Administration said Tuesday it will not approve any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse.

According to the agency, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”

OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.

The FDA’s decision came on the same day that Purdue’s patent on the original OxyContin expired, which normally opens the door for generic drug makers to launch their own cheaper versions of a product. Now, these generic companies will have to develop their own abuse-deterrent designs, preserving Purdue’s monopoly on the OxyContin market for the time being.

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Generic Oxy in N.Y. will enable abusers: Schumer

pillsscatteredNew York Sen. Charles Schumer is calling for added safety features to be imposed on generic forms of the prescription painkiller OxyContin that are set to hit the market in April. The lawmaker says he fears that these copycat versions, which do not include anti-abuse protections that cause them to turn into gels or chunks when crushed, could enable abusers, according to this article.

Many popularly abused prescription painkillers, including OxyContin, have been reformulated in recent years to allegedly make them abuse-resistant. But generic manufacturers are bringing their own versions of such drugs to market that don’t include tamper-proof properties.

The reformulation of OxyContin has prompted painkiller addicts across the country to switch to other opiates as well as heroin, recent research has shown.

Oxycodone prescriptions in Staten Island — which ranks third in oxycodone prescriptions per capita in the state — have remained relatively steady, with 141,022 written last year, compared to 142,059 in 2011, according to the article.

Overdose is now the leading cause of accidental death in New York, where almost 22.5 million prescriptions for all types of narcotic painkillers were written in in 2010, according to a recent report issued by the state’s attorney general.

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Fentanyl, hydromorphone replacing Oxy in Canada

PillsTighter controls on the popularly abused painkiller OxyContin in Canada have had positive results, but experts say the country’s massive pill addiction problem is still spiraling out of control: in 2010, for the first time, Canada surpassed the United States to become the highest opioid-consuming country, per capita, in the world, according to this article.

Moreover, in 2011, twice as many Ontarians were killed by opioid overdoses as drivers killed in car accidents, and addiction treatment programs are overflowing with people addicted to publicly funded drugs, the article adds.

As you may remember, OxyContin manufacturer Purdue Pharma replaced the painkiller last March in Canada with OxyNEO, an alternative billed as “tamper-resistant” because it is harder to crush. Today, Ontario’s OxyNEO prescriptions are about 60% what OxyContin prescriptions were a year ago; in Newfoundland, they’re 22%; in B.C., 67%, according to the article.

But other long-acting opioids such as fentanyl and hydromorphone — including Hydromorph Contin, also made by Purdue — are now among the fastest-growing causes of Ontario’s opioid overdose deaths, the article says.

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How did we get here?

pillflagThe numbers are staggering: in the United States, the number of overdose deaths from prescription opioids has more than tripled in the past decade, resulting in nearly 15,000 fatalities in 2008 alone and now accounting for more than 40 deaths every single day – not to mention the fact that estimated annual health care costs from this epidemic are as high as $72.5 billion.

How did we get here?

In the latest issue of Emergency Medicine News, Dr. Leon Gussow, a physician and editor of The Poison Review blog, examines how opioid analgesics – once feared as dangerous medications with high risk for addiction and overdose – became the drug class most frequently prescribed in the U.S., with four million patients a year receiving scripts for these powerful medications.

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