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FDA to Require Stricter Labels for Certain Painkillers

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Jarod Cassidy4 years ago

The U.S. Food and Drug Administration (FDA) announced Tuesday that it will be requiring stricter labels for some painkillers and will be require the drugs’ producers to conduct addition health safety research.

Changes to Painkiller Labels to take Effect by the End of the Year

“We can’t possibly prescribe these drugs knowledgeably unless we know what the incidence is of serious and fatal complications” – Dr. Nathaniel Katz, Tuft University School of Medication as published by the New York Times.

  • According to ABC, about 20 long-lasting painkiller previous labeled for use  for  “moderate to severe pain,” will require new labels stating that the drugs should only be prescribed for pain so severe it requires daily, around the clock treatment that is unable to be managed by over-the-counter drugs, immediate release opioids, or other safer alternatives.
  • The medications will also require box warnings informing of fetal risks that may arise from misuse or abuse of the medication.
  • The FDA is also requiring that the manufacturers of these medications conduct research to determine the effectiveness of these drugs and what risks may arise from long-term use.
  • Included in the drugs listed for label changes are OxyContin, Morphine and fentanyl.
  • The FDA hopes the label changes and additional research will curb the rising numbers of painkiller abuse and deaths that has occurred over recent years.

Dangers of Painkiller Abuse and Misuse

  • According to an article published in the New York Times, prescription drug abuse kills more Americans than car accidents or gunshot wounds.
  • The Washington Post alleges that increased abuse has occurred due to prescription drug companies downplaying the risks associated with opioids.
  • The Centers for Disease Control and Prevention (CDC) reports that sales of strong painkillers has risen by 300 percent between 1999 and 2010. Risks are especially high above women as painkiller overdose deaths among women rose by 400 percent over the same time span.
  • In 2008, 14,800 people died as a result of prescription painkillers every year, according to the same source.
  • For every death, there are 10 people treated for abuse, 32 emergency room visits for misuse or abuse, 130 people who are dependent painkiller abusers, and 825 non medical users.
  • The CDC states that in 2010, 2 million people admitted to having used prescription painkillers recreationally for the first time within the previous year – that equates to 5,500 first time recreational users a day.
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If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.


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