| April 17
April 17 The U.S. Food and Drug Administration
is requiring labels of all long-acting opioids to say they
should be used strictly for patients in severe pain, a response
to surging overdoses and deaths each year from the widely used
The health regulator in September proposed the label
changes, saying they were needed to highlight dangers of abuse
and possible death, as well as risks to newborns of mothers
taking the medicines. [ID: nL2N0H61AW]
The FDA, in a notice on its website on Wednesday, said it had
approved the proposed changes, which will indicate that such
drugs should only be used for severe pain. Currently, the labels
indicate they are appropriate for patients with moderate and
Opioids include formulations of morphine, oxycodone,
fentanyl and Oxycontin, a long-acting form of oxycodone. They
currently are widely prescribed, including for patients that
have had dental or surgical procedures, or those complaining of
back pain or headaches. Extended-release opioids will also fall
under the proposed FDA guidelines.
Updated language on the drug labels will stress the
medicines are meant for pain severe enough to require daily,
round the clock, long-term opioid treatment, and only for those
who have not had adequate pain relief from alternative
The labels will also include prominent warnings that chronic
maternal use of the drugs can result in potentially fatal opioid
withdrawal syndrome in newborns.
New opioids continue to be introduced, including a
long-acting form of hydrocodone called Zohydro, made by Zogenix
Inc, that has stirred controversy among U.S.
politicians, prosecutors and medical societies.
The FDA approved Zohydro in October despite concerns by the
agency's medical advisory panel over its potential for abuse.
The 12-hour capsules can be crushed and inhaled or injected,
making a full dose available immediately, according to critics.
Zogenix maintains the drug is a necessary option for
patients with severe, around-the-clock pain who cannot tolerate
Massachusetts Governor Deval Patrick last month announced a
ban on Zohydro, formally declaring a public health emergency
stemming from abuse of opioids in the state. But a federal court
judge on Tuesday reversed the ban, saying Massachusetts was
obstructing the FDA's constitutionally mandated authority.
More than 16,000 people in the United States died in 2010
from overdose deaths related to opioid abuse, according to the
FDA, with long-acting forms of opioids playing a
"disproportionate role" in drug abuse and deaths.
Although the updated language for long-acting opioids will
be more restrictive, the FDA has acknowledged the agency really
has no ability to ensure that doctors actually restrict their
prescriptions to patients with severe pain.
"The FDA does not have the authority to regulate the
practice of medicine, and health care practitioners may choose
to prescribe a legally marketed drug, based on their clinical
assessment," FDA spokeswoman Morgan Liscinsky said in September,
when the label changes were proposed.
Another worrisome aspect of opioids is their link to
burgeoning heroin addiction in the United States, in cities and
towns of all sizes.
Healthcare and law enforcement experts say many people,
including teenagers and young adults, become addicted to opioids
found in their family medicine cabinets or elsewhere, and then
turn to far-cheaper heroin when they no longer have access to
the opioids or cannot afford them.
(Reporting by Ransdell Pierson; Editing by Bernard Orr)