FDA Announced New Safety Rules for Prescription Painkillers

prescription painkillerFDA Announces New Regulations to Help Prevent Prescription Painkiller Abuse

On Wednesday, September 11th, the FDA announced that they will make changes to safety labeling and post-market study requirements to help prevent prescription painkiller abuse and addiction, especially with long-acting and extended-release opioid painkillers.

Extended-release and long-acting opioid prescription painkillers are often prescribed to patients who experience moderate to severe persistent pain, and need painkiller treatment for a long period of time.

However, prescription painkiller abuse and addiction is on the rise, and the FDA is attempting to find ways to prevent such problems.

One of the regulation changes would change labeling and wording on labels, to help health care professionals make better prescription decisions for individual patients. The labeling will emphasize that long-acting opioid prescription painkillers should only be prescribed to patients who have pain severe enough to need daily, around-the-clock treatment, when other options are ineffective.

The FDA says the hope is that the improved labeling will indicate that opioid painkillers are addictive, and there is an increased risk of abuse and overdose related to these medications.

The FDA will also change post-market requirements, which means that drug manufacturers must continue to conduct studies and clinical trials into prescription painkillers to determine the long-term risk of prescription painkiller abuse, addiction, and overdose.

Opioid prescription painkiller abuse and overdose led to 15,500 deaths in the United States in 2009, which, according to the FDA, is a 300% increase in fatalities over the last two decades.

“Opioids are important pain relieving medications that provide significant benefits when used appropriately,” Douglas Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research (CDER), said during a press briefing, according to USA Today. “But they have significant risks associated with inappropriate patient selection and improper use, whether accidental or intentional.”

“The change reflects a departure from an indication that was based on a severity scale and transitions to a more specific use,” Throckmorton said, via USA Today. “Patients in pain will not only be assessed by a rating on a pain scale, but a more thoughtful determination of pain.”

Prescription Painkiller Abuse and Overdose is a Serious Problem in the US

A study published in The Lancet in the first week of September showed that opioid prescription painkiller abuse caused 55% of 78,000 drug-related deaths in 2010. Opioid abuse, from prescription painkiller abuse to heroin addiction, caused the greatest global health burden of all illegal drug use. According to the study’s findings, two-thirds of those abusing opioid drugs were men, mostly in the 20-29 age range. In that group, 64% were also addicted to marijuana and/or amphetamines, and 70% were dependent on both opioids and cocaine.

The opioid abuse health burden was primarily in the United States, the United Kingdom, and Australia. The burden in developed countries was 20 times higher than in developing countries.

A federal study released in July of this year showed that women were the fastest-growing demographic for prescription painkiller overdose deaths. The study showed that between 1999 and 2010, the number of prescription overdose deaths among women increased fivefold, especially related to painkiller addiction. Although more men still suffer painkiller addiction and prescription overdose deaths, the rates at which men overdosed on painkillers in the same period only tripled.

The Strom Law Firm Can Help with Prescription Painkiller Abuse Charges

If you have received criminal drug abuse charges, or are suspected of abusing prescription drugs, you are not automatically guilty, and you do not give up any of your rights. The attorneys at the Strom Law Firm can help defend you. We offer free, confidential consultations to discuss the facts of your case. Do not let criminal drug charges such as trafficking or possession ruin your reputation and career prospects. Contact us today. 803.252.4800.

Leave a Reply