Poisonings From Opioids, Sedatives, And Tranquilizers On The Rise

According to an article published by WebMD, a recent research study revealed a dramatic increase in poisonings from prescription drugs such as opioids, sedatives, and tranquilizers. The study, which was published in the April issue of the American Journal of Preventive Medicine, indicates a 65% increase in such poisonings between 1999 and 2006.

Jeffrey H. Coben, MD, the study author noted:

[Certain prescription drugs] are just as powerful and dangerous as other notorious street drugs, and we need to ensure people are aware of these dangers and that treatment services are available for those with substance abuse problems.

After examining data from about eight million hospitalizations a year, the researchers made the following findings:

• Unintentional poisoning is now the second leading cause of unintentional injury death in the U.S.
• In 2005, unintentional poisoning surpassed motor vehicle crashes as the leading cause of unintentional injury death for people 35 to 54.
• Unintentional poisoning deaths have been on the rise for more than 15 years.
• Intentional poisonings from prescription rose 130% during the seven-year period, compared to 53% in intentional poisonings from other substances.
• The largest increase in the number of hospitalizations was caused by benzodiazepines. Hospitalizations from that class of drug increased 39% during the period studied.
• Hospitalizations for poisoning by barbiturates decreased 41% and hospitalizations for poisoning by antidepressants decreased 13%.
• Hospitalizations for poisoning by other drugs, medicinal, and biological substances increased 33%.
• Unintentional poisonings by other substances increased 21%.
• Unintentional drug-poisoning deaths increased 68% between 1999 and 2004, and the majority of the increase has been attributed to deaths associated with prescription opioids.

If you are currently taking opioids, sedatives, or tranquilizers, ask your doctor if these medications are truly necessary. Many of these drugs are highly addictive. If you have developed an addiction, now is the time to step up and seek help. Ask your primary care physician for assistance and information about available resources.

Contributing author: Jon Stefanuca

FDA Law Blog: Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?

Have you ever wondered what the FDA’s authority is to force a change from prescription medication to over-the-counter?  The following blog by the firm of Hyman, Phelps & McNamara just came across on my Tweetdeck – FDA Law Blog: Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?.

Kudos to this firm for a well-written piece on the rule-making authority of the FDA.  It is an instructive piece on the concepts of ‘adjudication’ and ‘rule making’ and how those potential avenues of ‘forced change’ have played out over the decades since the 1951 Durham-Humphrey Amendments to the FDC Act gave FDA the authority to require that drugs be limited to Rx status when they cannot be used safely for OTC use.  “Thus, the underlying presumption (then and now) is that Rx restrictions are the exception, and that if a drug can be used safely and effectively OTC it should be.”

After presenting a detailed history of the amendments to the Act creating the FDA and the various attempts to effect a ‘forced switch,’ the authors conclude:

FDA in its petition decision appears to have determined that informal notice-and-comment rulemaking is the appropriate route to effect a forced switch over an NDA sponsor’s objections, and that administrative adjudication is not necessary.

While FDA rule-making and policies are certainly not one of my areas of expertise, it does make me wonder if all of this talk about health care reform being contingent – at least in part by some – on tort reform is a bit myopic.  Ever wonder about the cost of prescription medications, the Medicare donut (okay – doughnut by some) hole and drug lobbyists on our health care crisis?  Maybe the FDA can start taking charge with the power it has been given to consider a list of drugs that just might make sense to ‘force a switch’ to OTC at a much lesser cost to the consumer.