FDA Requires Changes to Painkiller Warning Labels

The FDA issued a new requirement that stronger warning labels be included on extended-release opioid painkillers, such as: 

  • Vicodin;
  • OxyContin; and
  • morphine.

Overdose injuries and deaths from painkillers is becoming a serious issue, as many abuse and misuse them. The new label will warn patients and doctors about these potential fatal risks.

The label will stress that long-acting opioids should be prescribed to patients who don’t benefit from immediate-release opioids or other over-the-counter (OTC) pain medications. They are intended for individuals who experience nonstop pain.

The hope is that changes to warning labels will increase awareness of the dangerous risks and reduce the rate of misuse. Measures taken in the last couple of years to warn about the dangers has done little to reduce overdose fatalities. The number of deaths increased by 12 percent between 2008 and 2010.

Drug Labeling Requirements

Proper labeling of both prescription and OTC medications is an important component to drug safety. The FDA has both recommendations and rules regarding the correct way to label a medication.

One example is a boxed warning that must specifically address risk of serious adverse reactions. For instance, nonsteroidal anti-inflammatory drugs warn of cardiovascular events, ulcers and gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs) warn of increased risk of suicide in children and adolescents.

Get Legal Help if Injured by a Poorly Labeled Drug

If a drug fails to warn of adverse reactions and a patient suffers injury, the drug manufacturer may be liable for damages. Those injured can consult an attorney at Gacovino, Lake & Associates to discuss taking legal action. Call 800-246-4878 to set up a consultation.

Related Posts