FDA Requiring Long-term Research of OxyContin Use

UPDATE: Purdue Pharma, maker of OxyContin, has agreed to turn over to California authorities its list of 49 CA doctors suspected of over-prescribing the much-abused opioid pain killer.

Purdue revealed last month that it has been keeping a list of high-prescribing doctors since 2002. There are 1,800 doctors from across the country on the list presently, though Purdue Pharma has said that some of those may no longer be practicing medicine, according to an LA Times report.

Examination of the list by authorities might make more clear the role of physicians in the abuse of OxyContin. In the past, pharmacy break-ins, teen thefts and patients using multiple doctors have been blamed. Considering that Purdue has 1,800 or so suspicious docs, it is odd that they have alerted the authorities about only 154 cases. It’s horrible to think about how many lives have been ruined and how many overdoses have occurred while Purdue sits on its list of doctors. Fortune magazine reported in 2011 that Purdue Pharma made almost $3 billion in 2009 on OxyContin.

California has passed 3 bills (still awaiting the Governor’s signature) to help track overdose deaths back to the doctors and pharmacists where the prescriptions originated. State Sen. Ted Lieu (D-Torrance) said in an interview with FiercePharma Thursday, “We know that legal prescription painkillers kill more people in overdose deaths than heroine or cocaine combined, and the issue of some prescribers who are recklessly or intentionally prescribing high levels of highly addictive narcotics to their patients has been a problem that we’re trying to address in California.”

FDA Requiring Long-term Research of OxyContin Use

September 19, 2013 It’s going to be harder to get OxyContin. The FDA has acknowledged a “crisis of misuse, abuse, addiction, overdose, and death” from extended-release and long-acting opioids (ER/LA opioids). The best known of these drugs is OxyContin, which had $3.1 billion sales last year.

The FDA is requiring changes in labeling and prescribing directions for this class of drugs. The guideline of “moderate to severe” pain will be changed to “the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” Doctors are not to prescribe for use “as needed.” Further studies and clinical trials will now be required of the drug companies that make ER/LA opioids in order to assess the risks of long-term use of these drugs. Constipation and nausea are the most common side effects. Long-term opioid use is associated with a number of adverse consequences in addition to overdose, including decreased cognitive function, constipation, hyperesthesias (increased pain due to the use of opioids), immune suppression, hormonal changes, addiction, and diversion of medication (sale to others). (Source: Mitchell H. Katz, MD)

Men are more likely than women to die of painkiller overdoses. More than 10,000 men and 6.700 women all died of prescription painkiller overdoses in 2010 (the most recent year for which data is available). For every woman who dies, 30 women go to the ER for painkiller misuse or abuse, according to CDC VitalSigns Opioids are highly addictive, nearly as addictive as heroin. Until the late 1990s opioids were only prescribed to those dying of cancer or other painful causes. Addiction and other long-term risks don’t apply in those situations.

However, in the late 1990s an extended-release mechanism was added to an opium product and named OxyContin. The manufacturing company, Purdue, claimed that it was nearly addiction-proof, The FCA accepted that claim and gave approval for OxyContin to be marketed for a wider range of long-term pain relief. In a 2007 plea in a criminal case Purdue acknowledged that its promotional materials had contained misleading or inaccurate data and that its sales force made claims unsupported by science that falsely downplayed the addiction risks. (For more detailed info, see New York Times article.) In 2010 Purdue re-formulated OxyContin into an “abuse-resistant” mechanism. The FDA has given approval to label the new formulation has “properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” Let’s hope that the drug dealers aren’t as quick to find a way to defeat the anti-abuse properties in the new OxyContin as they were in the old formulation. Purdue Pharma is based in Stamford, CT, and makes a small variety of pain management products. Prescription products In addition to OxyContin are: Butrans, Dilaudid, MS Contin and Ryxolt. Non-prescription include some well-known products such as Betadine and Senokot.


Suzanne B. Robotti

Suzanne B. Robotti

Suzanne Robotti founded MedShadow Foundation in 2012. Learn more about Su and her mission.


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