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Fentanyl, an extremely dangerous painkiller at the heart of the opioid epidemic in the United States, has been over-prescribed by doctors, according to a report released Tuesday in which health authorities and manufacturers would be accused of Be too lax.
The drug is a synthetic opioid up to 100 times more potent than morphine and widely sold on the black market.
But it is prescribed in some cases of cancer under restrictions supposedly very strict, in the form of lozenges, lollipops or sprays under the tongue. It is supposed to be used only in cancer patients for whom other opioid analgesics have been insufficient.
The report in the Journal of the American Medical Association, or JAMA, said that this was not the case, however.
The survey, conducted by experts at Johns Hopkins University, revealed that of the thousands of patients who had been prescribed fentanyl, between one-third and one-half of them would never have received the drug.
The researchers found that one in five doctors did not know that fentanyl was only supposed to be used by opioid-tolerant cancer patients.
As a result, it has been poorly prescribed for much less serious conditions such as lower back pain or chronic headaches.
"The drug can kill you," said one of the report's authors, Caleb Alexander, co-director of the Johns Hopkins Center for Safety and Efficacy.
"There is no doubt that individuals have died from inappropriate prescription of these products," he said.
"The purpose of this program was to prevent exactly the current use," he said about fentanyl, which became the deadliest drug during an epidemic that killed 70,000 people in the United States in 2016.
The team of researchers has been battling for four and a half years to get 5,000 pages of Fentanyl program documents from the FDA.
Legally, doctors are allowed to prescribe a drug for a condition other than that for which it is indicated. The role of the FDA is to regulate the laboratories that make the drugs, not the doctors.
But as part of their oversight responsibility, the manufacturers "were supposed to monitor and potentially disorganize prescribers who violated the terms of the program, yet no prescriber was identified and uncoiled," Alexander said.
A spokesman for the FDA said the agency shared the concerns expressed in the report.
"The FDA will soon share the next steps planned to ensure that the program is working to mitigate the risks of these drugs and that they are only prescribed to opioid-tolerant patients," said the gatekeeper. Floor-.
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