Painkiller Overdoses Target of New FDA Safety Measures

Federal drug regulators have unveiled a new plan that they hope will cut back on prescription painkiller overdoses, which have increasingly become a serious health concern in the United States. 

On July 9, the FDA announced new safety measures for extended-release and long-acting opioid medications, like OxyContin, which includes new educational courses for patients and prescribing doctors.

The program is part of a Risk Evaluation and Mitigation Strategy (REMS), which is typically put in place when a drug has been deemed dangerous but necessary.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The REMS plan requires more than 20 companies that make opioid painkillers to provide access to education programs that will be built on an FDA-approved model. The strategy also requires that the companies provide new educational material for patients.

The brand-name drugs affected by the strategy include Duragesic, Palladone, Dolophine, Avinza, Kadian, MS Contin, Oramorph, Embeda, OxyContin, Opana ER, Exalgo and Butrans. The generic drugs affected by the strategy include fentanyl, methadone, morphine, and oxycodone.

Education Targets Doctors and Patients

Doctors will be taught how to choose patients appropriately, how to teach their patients safe use of powerful painkillers and what signs to look for in order to spot abuse and addiction.

Through the program, patients will be provided with updated medication guides and other documents that instruct them on the proper care of the drugs, signs of overdose, advice on how to store the drugs safely and emergency contact information.

Opioid painkillers, also known as opioid pain relievers (OPRs) are a class of analgesics that includes methoadone, oxycodone and hydrocodone, among others. They are controlled substances that are supposed to only be obtained through prescription for the alleviation of pain. However, abuse of the drugs has increased steadily through the years.

The new FDA program does not provide a plan for dealing with prescribing doctors who intentionally run what have been called “pill mills,” where they supply a steady stream of patients with powerful painkiller prescriptions with no questions asked. However, the program requires both companies and the FDA to periodically review how well the REMS is performing.

The FDA estimates that the new education programs will begin to be available by March 1, 2013. However, there is no mandatory requirement that doctors participate.

According to the FDA, long-acting and extended-release painkillers were prescribed 22.9 million times last year. The prevalence of the drugs has led to prescription painkiller overdose deaths surpassing the number of deaths linked to abuse of illegal substances like cocaine according to an overdose report last year by the U.S. Centers for Disease Control and Prevention (CDC). The CDC notes that there were 15,597 opioid overdose deaths in 2009; four times the number of such deaths recorded in 1999.

1 Comments

  • AliyeAugust 30, 2012 at 6:05 am

    Nice of you to join us! It is an EPIDEMIC of wide proportion!!! It is the naoitns worst enemy! Get rid of the Dr. That are handing them out like pez candy and just maybe #1 people will hit off their lazy ass to work and stop taking disability and welfare. (stop playing their game!) # 2 save lives, but we need caring resources for long term help! (these people can no longer function in society)[Show More]Nice of you to join us! It is an EPIDEMIC of wide proportion!!! It is the naoitns worst enemy! Get rid of the Dr. That are handing them out like pez candy and just maybe #1 people will hit off their lazy ass to work and stop taking disability and welfare. (stop playing their game!) # 2 save lives, but we need caring resources for long term help! (these people can no longer function in society) It is not just the surface we are looking at. I know my niece has been handed drugs for 10 years from doctors! They know she is an addict .rotten teeth, no brain! I have friends whom families have been ruined because the resources have taken every penny. Just saying .it is a terrible, terrible disease! Please help!

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery
Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery (Posted today)

A federal magistrate judge is forcing Uber to hand over potentially hundreds of thousands of incident files involving reports of passengers who suffered sexual misconduct or sexual assault at the hands of the rideshare service's drivers.

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted yesterday)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted 2 days ago)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.