Tag Archives: FDA

FDA shutters rogue Internet pharmacies in massive crackdown

computerpillsFederal regulators have launched a massive crackdown on Internet pharmacies that are selling unapproved and potentially dangerous prescription medicines that could pose significant public health risks. The U.S. Food and Drug Administration said it has shut down 1,677 websites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards. Regulators have also seized more than $41 million worth of illegal medicines and arrested 58 people, while a number of additional websites have received regulatory warnings, according to the FDA.

Several sites had interfaces and names that could easily be confused with legitimate pharmacy retailers, such as Walgreens-Store.com, which imitated the well-known drugstore chain’s website, which is actually Walgreens.com, the agency said.

The crackdown marks the largest Internet-based action of its kind, the agency said, adding that prescription medicines, including those purchased online, should only be used with a valid prescription and under the supervision of a licensed health care provider.

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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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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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N.Y. imposes stricter controls on hydrocodone

purplepillsIn New York, Attorney General Eric Schneiderman has issued a letter to doctors, pharmacists and other medical professionals alerting them that the widely abused prescription painkiller hydrocodone is now a Schedule II controlled substance under new regulations recently passed by the state. In the letter, Schneiderman calls the drug “highly addictive,” noting that statewide prescriptions for hydrocodone filled increased from 3.8 million to 4.5 million from 2007 to 2009, an increase of 18.4%, while those for oxycodone have increased 82%. In many regions of the state, hydrocodone is the most commonly prescribed controlled substance, according to the letter.

The changes apply only to New York state, although the FDA is currently considering whether to reclassify hydrocodone-containing painkillers from Schedule III drugs to the more restrictive Schedule II on a federal level. In January, an expert panel voted 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

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Painkillers drive up drug OD deaths for 11th straight year

pillsoverdoseDrug overdose deaths increased for the 11th consecutive year in 2010, and most of those deaths were accidents involving addictive painkillers, according to new federal data. In 2010, there were 38,329 drug overdose deaths nationwide, and medicines – mostly prescription drugs – were involved in nearly 60 percent of overdose deaths, surpassing deaths from illicit narcotics, according to a study by the CDC published in the Journal of the American Medical Association. Opioid drugs such as OxyContin and Vicodin were the biggest problem, contributing to 3 out of 4 medication overdose deaths.

Last month, the FDA began considering whether more controls need to be placed on opioid prescribing. The agency is also considering reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II.

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FDA mulls stronger controls on opioid prescribing

PillsLast week, the U.S. Food and Drug Administration held a two-day hearing to determine if more controls need to be placed on opioid prescribing. The hearing was the result of a citizen’s petition filed by the Physicians for Responsible Opioid Prescribing (PROP) and other advocates.

The petition asks the FDA to change the indication on opioid analgesics like OxyContin from “moderate to severe pain” to “severe pain” and to include a suggested duration of 90 days of continuous use. Current labels on opioid analgesics simply indicate that opioids are to be used for “moderate to severe pain,” without further qualification.

The FDA is still taking comments before it makes its decision regarding this issue, and you can let it know what your views are here.

To hear impact statements from those who testified at the meeting, go here.

Separately, the FDA is considering reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II. In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

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FDA panel backs stricter controls on Vicodin

The U.S. Food and Drug Administration may be set to reclassify hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, with an expert panel voting 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

The FDA usually, but not always, follows the advice of its advisory panels.

The misuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the Centers for Disease Control and Prevention.

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FDA mulls hydrocodone reclassification

This week, the U.S. Food and Drug Administration is set to conduct a two-day hearing on whether hydrocodone products such as Vicodin should be more highly regulated like other narcotics like OxyContin and morphine, this article reports. FDA researchers said in recent briefing documents that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction, the article says. But critics say hydrocodone is potent and highly addictive, and that updating the drug’s classification could help bring the prescription drug addiction epidemic under control, according to the article.

Last year, pharmacy interest groups defeated an amendment to the FDA Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II.

Combination hydrocodone products such as Vicodin and Norco are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would have rescheduled hydrocodone from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone.

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