FDA Cracks Down on Opioid ManufacturersMarch 4, 2013 Addiction Treatment
The Food and Drug Administration cracks down on opioid manufacturers saying on Monday, that they have issued letters to companies that make opioid drugs, including morphine, oxycodone and methadone requiring that they develop plans to reduce the misuse of their painkillers, which cause hundreds of deaths each year. The FDA has issued a number of warnings on the drugs in recent years and some companies already have plans to manage the drug’s risks.
These drugs are normally used by people already taking narcotics, such as cancer patients, to treat severe flare-ups of pain. Despite their ability to relieve chronic pain, the drugs can be highly addictive and are often abused for their euphoric effects.
Dr. John Jenkins, FDA’s chief of new drugs said, “Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade.” According to FDA, about 21 million prescriptions for opioids were dispensed in 2007.
Let us hope the message finally comes across, Stop the Abuse!
On March 3, the Food and Drug Administration plans to meet with 16 drug makers to discuss risk-management plans for the medications. Such plans can include bolstered warning labeling, restrictions on patients who can receive the drugs and cautionary letters to physicians.
Companies asked to attend include makers of generic pills as well as brand-name products, like those from Johnson & Johnson, King Pharmaceuticals and Purdue Pharma.
The continuing deaths from these drugs are being blamed on abuse by patients and inappropriate prescribing by physicians. The Food and Drug Administration has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, an unapproved use. The FDA said patients will also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose of the drug.
“We’re focusing on these products because they generally contain very high doses of the drugs and need to be used very carefully,” Jenkins said.