Originally published July 17 2008
Painkiller Patch Fentanyl May Have Killed 3,500 People, Warns FDA
by David Gutierrez, staff writer
(NaturalNews) The popular patch version of the pain killer fentanyl is suspected in more than 3,500 deaths, and the FDA has issued a new warning about its use.
The fentanyl patch is designed for patients with chronic pain, especially those who have trouble swallowing pills. The patch steadily releases the drug over the course of three days.
But the FDA warns that heat and exercise can cause the patch to release the drug at a faster and potentially lethal rate. Echoing the warning it issued in 2005, the FDA has told patients on fentanyl to avoid taking hot showers or using heating pads while wearing the patch. Patients who experience breathing problems while on the patch should call their doctors immediately, because high doses of the drug can cause the respiratory system to shut down.
The FDA also instructed doctors to only issue the patch to patients whose pain is not expected to improve and who are already safely taking pain killers in the morphine (opioid) family.
In order to strengthen the 2005 warning, which even the FDA acknowledges was insufficient, the agency has instructed drug makers to send out brochures that explain the dangers of the drug in plain language.
A 2006 study identified fentanyl as the responsible drug for more accidental deaths than any drug other than oxycodone, with 3,545 deaths linked to fentanyl between 1998 and 2005. According to lead author Thomas J. Moore, the patch form was "by far the largest contributor."
Many safety advocates have criticized the FDA's most recent warning as insufficient, noting that fentanyl has killed far more people than the 932 deaths attributed to Vioxx, which the FDA has withdrawn from the market
"I think there is more that needs to be done, or else we're just going to see this [warning] happen again another two years from now," said Michael Cohen, president of the Institute for Safe Medication Practices. "The deaths are going to continue."
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