Tag Archives: ARPO

FDA unveils new labeling rules for opioids

pill bottlesUnder pressure from activists and other critics, the U.S. Food and Drug Administration on Tuesday announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin.

According to the agency, the changes are aimed at combatting “the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities.”

The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.

The FDA’s move was met with skepticism by some activists who were concerned the changes do not go far enough. Pete Jackson, the president of Advocates for the Reform of Prescription Opioids, said the development could be viewed as either a step in the right direction or as “another smokescreen put out by the FDA to make it look like they are doing something.”

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

For Purdue’s ‘poster children,’ Oxy led to addiction, death

The Milwaukee-Wisconsin Journal Sentinel has produced an investigative report following up with the “poster children” of OxyContin – a group of seven people who were featured in a promotional video for the painkiller that was put out by Oxy maker Purdue Pharma in the late 1990s. Fourteen years later, it’s a mixed bag. Two of the seven patients have died: one man flipped his car after falling asleep at the wheel, high on OxyContin, while a second man was found dead in his apartment of apparent heart failure. Both men were active opioid abusers at the time of their deaths. A third patient became addicted to Oxy but was able to quit after realizing she was headed for an overdose. Three patients still say the drug helped them cope with their pain and improved their quality of life, while the seventh patient declined to answer questions.

The doctor who enlisted his patients for the video – a pain specialist who was also a paid speaker for Purdue at the time – told the Journal that his statements urging physicians to consider prescribing opioids more often went too far, and that success stories may be “quite rare.” In the video, the doctor had claimed that the rate of addiction among pain patients was much less than 1 percent, but he told the Journal that figure did not come from long-term studies of chronic pain patients.

Posted in Informational, Pharmaceutical Industry, Trends | Tagged , , , , , , , , , , , , , , , , , , | 2 Comments

New Vicodin draws activist fire amid opioid abuse epidemic

San Diego-based Zogenix Inc.’s bid for FDA approval to begin marketing Zohydro – a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin – has prompted some activists to appeal to the agency not to rubber-stamp more opioid drugs in the midst of an out-of-control epidemic. Proponents of extended-release versions of opioids – such as Purdue Pharma’s recently reformulated OxyContin, OP – claim the drugs are safer because they are “abuse-resistant,” but others point out that many opioid-addicted people simply swallow the pills whole. (Addicts are also already finding their way around allegedly tamper-proof versions.)

One group, Advocates for the Reform of Prescription Opioids, has launched a letter-writing campaign urging the FDA not to sign off on more opioids. According to ARPO president Pete Jackson, the approval of extended-release hydrocodone will only exacerbate the opioid addiction epidemic, which killed nearly 15,000 Americans in 2008, surpassing the number of deaths due to car accidents. “It boggles the mind that, with the steadily rising toll of death and addiction from prescription opioids that has gone on unabated for more than ten years, we could be facing the approval of still more potent narcotic pain relievers in the form of pure, extended-release hydrocodone,” Jackson says. “It makes NO sense for the FDA to approve more deadly opioids at a time when they have not figured out how to stop the carnage from the opioids already on the market. This will add thousands to the annual death toll.”

Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends | Tagged , , , , , , , , , , , , , , , , , , | 3 Comments