FDA asks drugmaker to stop selling its opioid painkiller
Photo/Andrew Harnik, File)
Linda A. Johnson
Trenton, N.J. (AP) - U.S.
regulators want a narcotic painkiller involved in the opioid epidemic
off the market amid data showing people continue to abuse it.
The Food and Drug Administration
said Thursday it has asked Endo Pharmaceuticals to stop selling its
reformulated, extended-release painkiller, Opana ER, after concluding
the drug’s risks outweigh its benefits.
It’s the first time the FDA has
asked a drugmaker to remove an opioid painkiller from the market. The
agency said it has seen a “significant shift” from people crushing and
snorting Opana ER to get high to injecting it.
Endo said in a statement it’s
“reviewing the request and is evaluating the full range of potential
Wall Street responded quickly with
a sell-off, and Endo shares plunged 13.4 percent to $11.93 in trading
after U.S. markets closed.
The FDA move comes after advisers,
reviewing the safety of Opana ER at a March hearing, voted 18-8 against
keeping it on the market.
Besides contributing to overdoses,
abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C
in southern Indiana linked to sharing needles, according to the FDA.
“We are facing an opioid epidemic -
a public health crisis, and we must take all necessary steps to reduce
the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott
Gottlieb said in a statement. “We will continue to take regulatory steps
when we see situations where an opioid product’s risks outweigh its
About 2 million Americans are
addicted to prescription opioids, and 91 die every day from overdosing
on a painkiller or much-cheaper heroin.
Endo first got U.S. approval for
its extended-release opioid, Opana ER, in 2006. It reformulated that
drug in 2012 and claimed the changes made it harder to manipulate
physically or chemically to abuse it. Endo tried to persuade FDA
officials that the new formulation was abuse-resistant, which likely
would have given the product a marketing advantage in the crowded,
lucrative category of opioid painkillers.
The FDA didn’t agree, refusing to
let Endo market the new formulation as abuse deterrent when it granted
approval for sales several years ago.
If Endo doesn’t comply with the
FDA’s request to stop selling Opana ER, the agency can hold a hearing
and start a formal process for rescinding its approval.
According to the FDA, there are no
generic versions of the reformulated Opana ER on the market. However,
generic versions of both the original Opana ER and the original
immediate-release version, called oxymorphone ER, are on sale.
Those generic products might also
face action by the FDA, which said it is “assessing the latest available
data on abuse patterns.”
Endo Pharmaceuticals makes generic
pills and specialty drugs, which generally are expensive medicines for
complex disorders. It’s part of Endo International plc, which is based
in Dublin, Ireland, and has U.S. headquarters in the Philadelphia suburb
Endo had about $4 billion in
revenue last year, only $159 million of that from Opana.
Tips for finding opioid
alternatives for surgical pain
The Associated Press
Headed for surgery? Specialists say
talking to your doctors ahead of time may turn up ways to control
post-operative pain while minimizing use of those problematic
painkillers called opioids. Among the advice:
- Ask what to expect. Patients who
are overly anxious about impending pain tend to feel worse.
- Ask your surgeon or the
anesthesia team if you qualify for a nerve block or other form of
regional anesthesia that numbs a particular section of the body. A nerve
block administered through a catheter can allow repeated doses to keep a
spot numb for days.
- Ask doctors what combinations of
non-opioid medications they use to attack pain, a practice called
“multimodal analgesia.” Options include intravenous doses of
acetaminophen or anti-inflammatories, oral anti-seizure drugs that also
work on nerve pain, sedatives and injected numbing agents.
- Ask if your hospital offers a
program called “enhanced recovery after surgery” that stresses a variety
of pain-control and other techniques to get patients eating, drinking
and on their feet sooner so they feel better faster.
- If you’re being prescribed
opioids to take home after surgery, ask how many you really need and
what to do with any leftovers so they’re not misused. Some hospitals
allow sending home only a few days’ supply.
- If you’ve had trouble with any
type of substance abuse in the past, be frank with your doctors. They
may bring in a pain or addiction specialist to help craft a customized
Marijuana extract helps some kids with epilepsy, study says
According to a study published Wednesday by the New
England Journal of Medicine, GW Pharmaceuticals’ Epidiolex, a medicine
made from marijuana, but without TCH, cut seizures in kids with a severe
form of epilepsy, which strengthens the case for more research into
pot’s possible health benefits. (AP Photo/Kathy Young)
A medicine made from marijuana,
without the stuff that gives a high, cut seizures in kids with a severe
form of epilepsy in a study that strengthens the case for more research
into pot’s possible health benefits.
“This is the first solid,
rigorously obtained scientific data” that a marijuana compound is safe
and effective for this problem, said one study leader, Dr. Orrin
Devinsky of NYU Langone Medical Center.
He said research into promising
medical uses has been hampered by requiring scientists to get special
licenses, plus legal constraints and false notions of how risky
“Opiates kill over 30,000 Americans
a year, alcohol kills over 80,000 a year. And marijuana, as best we
know, probably kills less than 50 people a year,” Devinsky said.
The study was published Wednesday
by the New England Journal of Medicine.
For years, desperate patients and
parents have argued for more research and wider access to marijuana,
with only anecdotal stories and small, flawed studies on their side. The
new study is the first large, rigorous test - one group got the drug,
another got a dummy version, and neither patients, parents nor doctors
knew who took what until the study ended.
It tested a liquid form of
cannabidiol, one of marijuana’s more than 100 ingredients, called
Epidiolex (eh’-pih-DYE’-uh-lehx). It doesn’t contain THC, the
hallucinogenic ingredient, and is not sold anywhere yet, although its
maker, GW Pharmaceuticals of London, is seeking U.S. Food and Drug
The company paid for, designed and
helped run the study, and another doctor involved in the study has
Patients in the study have Dravet
(drah-VAY) syndrome, a type of epilepsy usually caused by a faulty gene.
It starts in infancy and causes frequent seizures, some so long-lasting
they require emergency care and can be fatal. Kids develop poorly, and
their mental impairment seems related to the frequency of seizures -
from 4 to as many as 1,717 a month in this study.
Allison Hendershot’s 12-year-old
daughter Molly was four months old when she had her first. It lasted an
hour and a half, and emergency room doctors medically induced a coma to
stop it. Molly, who lives in Rochester, New York, has tried more than
half a dozen medicines and a special diet, but her seizures continued.
“We literally could not count how
many” before she started in the study, her mom said.
It included 120 children and teens,
ages 2 to 18, in the U.S. and Europe. They took about a teaspoon of a
sweet-smelling oil twice a day (drug or placebo) plus their usual
anti-seizure medicines for 14 weeks. Their symptoms were compared to the
previous four weeks.
Serious seizures with convulsions
dropped from around 12 a month to about six for those on the drug and
did not change in the others. Three patients on the drug became
seizure-free during the study.
It’s no panacea, though. Diarrhea,
vomiting, fatigue, sleep problems and other issues were more frequent in
the drug group. Twelve patients quit the study - nine on the drug and
three in the placebo group.
Hendershot thinks her daughter got
the dummy medicine because they saw no change in her seizures until the
study ended and all participants were allowed to try the drug.
By the second day they saw a
difference, and “she went seizure-free for two months. It was pretty
remarkable,” Hendershot said.
The fact the drug came from
marijuana “did not matter to me at all,” she said. “If it helps, we’re
happy. I think people hear ‘cannabis’ or that it comes from marijuana
and immediately there’s a stigma attached to it.”
For those who swear marijuana
helped them, “anecdote has been confirmed by data,” Dr. Samuel Berkovic
writes in a commentary in the medical journal. He is an epilepsy
researcher at the University of Melbourne in Australia, where medical
marijuana was legalized last year, and has worked with Devinsky in the
The drug is being tested in a
second large study in kids with Dravet syndrome, and in studies of some
other types of epilepsy. (AP)
Science Says: What’s known and not known about marijuana
April 15, 2017 file photo shows marijuana plants on display at a medical
marijuana provider in downtown Los Angeles. A new study released on
Wednesday, May 24, 2017 about using a marijuana ingredient to treat
epilepsy joins a limited record of scientific knowledge about the harms
and benefits of pot. Experts have called for a national effort to learn
more about pot and its chemical cousins. (AP Photo/Richard Vogel)
New York (AP) - A new
marijuana study joins a limited record of scientific knowledge about the
harms and benefits of pot.
The research published Wednesday is
the first rigorous test of a marijuana compound in treating a certain
form of severe epilepsy. It found that an ingredient of marijuana - one
that doesn’t give pot smokers a high - reduced the number of seizures in
In the U.S., more than two dozen
states allow medical use of marijuana. Federal drug regulators have not
approved marijuana itself, but they have allowed man-made, chemically
related medicines to treat loss of appetite in people with AIDS, and
nausea and vomiting caused by cancer therapy. A marijuana extract is
sold in Britain for nerve pain and other problems from multiple
In January, a U.S. advisory
committee concluded that the lack of scientific information about
marijuana and its chemical cousins, called cannabinoids, poses a risk to
public health. The experts called for a national effort to learn more.
In a report from the National
Academies of Sciences, Engineering and Medicine, they also rounded up
what is known. Here are some of its conclusions.
There’s strong evidence that
marijuana or cannabinoids:
- Can treat chronic pain in adults
- Can ease nausea and vomiting from
- Can treat muscle stiffness and
spasms in multiple sclerosis as measured by what patients say, but less
strong evidence if the changes are measured by doctors
On the other hand, it also found
that pot smoking may be linked to:
- Risk of developing schizophrenia
and other causes of psychosis, with the highest risk among the most
- Risk of a traffic accident
- More frequent chronic bronchitis
episodes from long-term use
- Lower birthweight in offspring of
There’s some evidence that pot or
- Improve short-term sleep in
people with some medical conditions
- Boost appetite and ease weight
loss in people with HIV or AIDS
- Ease symptoms of post-traumatic
stress disorder and improve outcomes after traumatic brain injury
Similarly, some evidence suggests
pot use may be linked to:
- Triggering a heart attack
- An increased risk of developing a
lung condition called chronic obstructive pulmonary disease
- Pregnancy complications when used
by the mother
- Impaired school achievement and
- Increased suicidal thoughts and
suicide attempts, especially among heavier users
- Risk of developing bipolar
disorder, especially among regular users.
There’s not enough evidence to know
if marijuana or cannabinoids can:
- Ease symptoms of irritable bowel
- Help with movement problems
associated with Parkinson’s disease
- Improve mental health outcomes in
people with schizophrenia
Similarly, there’s not enough
evidence to know if marijuana is linked to:
- Increased risk of heart attacks
over time from chronic use
- Development of post-traumatic
- Changes in the course or symptoms
of depression disorders
- Development or worsening of
- Accidents or injuries on the job
Report: More Americans with
Alzheimer’s are dying at home
New York (AP) -
One in 4 Alzheimer’s deaths in the United States is now occurring at home -
a startling increase that marks a shift away from hospitals and nursing
homes, according to a report released Thursday.
Alzheimer’s deaths in
hospitals and nursing homes or other long-term care facilities shrank from
more than 80 percent to 60 percent over 15 years. Meanwhile, those dying at
home rose from 14 percent to 25 percent, the Centers for Disease Control and
Alzheimer’s disease is
a progressive brain disorder that impairs memory, judgment and other mental
abilities. It’s most common in the elderly. In the final stages of the
disease, people have trouble eating and carrying on a conversation, are
vulnerable to pneumonia and infections, and often need around-the-clock
The Alzheimer’s death
rate has risen nearly 80 percent since 1999 and the disease is the nation’s
sixth leading cause of death.
Deaths have been
climbing for some time. A big reason is declines in other causes of death -
particularly heart disease and cancer - are enabling more people to live
long enough to die from Alzheimer’s, experts say.
In the new report, the
CDC analyzed death certificates from 1999 to 2014 and found a surprise - a
shift in where people with Alzheimer’s are dying.
Experts said it’s not
clear why more people with Alzheimer’s are dying at home than in hospitals
or nursing homes.
explanation is patient preference. For people losing their memories, it can
be a comfort to remain in familiar surroundings, said Jeff Huber, president
of Home Instead Senior Care, an Omaha-based company that provides home care
to tens of thousands of clients with Alzheimer’s and dementia.
But it can be difficult
for families. Even if they have the insurance or money to get home-care
workers to help, caring for an Alzheimer’s patient can take an exhausting
toll, experts said.
As baby boomers age,
“the numbers dying from Alzheimer’s are just going to get worse,” said Keith
Fargo, director of scientific programs for the Alzheimer’s Association.
The CDC also released
Alzheimer’s death rates for counties.
The counties with the
highest rates over 10 years were tiny Eddy County in east central North
Dakota, and Hamlin County in eastern South Dakota. Several counties in the
South were near the top of the list.
It’s not clear why.
Doctors in some places might be better at diagnosing Alzheimer’s, or
coroners and medical examiners might more commonly put Alzheimer’s on death
certificates instead of other causes, said Christopher Taylor, a CDC
epidemiologist who was the report’s lead author.
Research shows aggressive treatment
of sepsis can save lives
Washington (AP) -
Minutes matter when it comes to treating sepsis,
the killer condition that most people probably have never heard of, and new
research shows it’s time they learn.
Sepsis is the body’s
out-of-control reaction to an infection. By the time patients realize
they’re in trouble, their organs could be shutting down.
New York became the
first state to require that hospitals follow aggressive steps when they
suspect sepsis is brewing. Researchers examined patients treated there in
the past two years and reported Sunday that faster care really is better.
Every additional hour
it takes to give antibiotics and perform other key steps increases the odds
of death by 4 percent, according to the study reported at an American
Thoracic Society meeting and in the New England Journal of Medicine.
That’s not just news
for doctors or for other states considering similar rules. Patients also
have to reach the hospital in time.
“Know when to ask for
help,” said Dr. Christopher Seymour, a critical care specialist at the
University of Pittsburgh School of Medicine who led the study. “If they’re
not aware of sepsis or know they need help, we can’t save lives.”
The U.S. Centers for
Disease Control and Prevention last year began a major campaign to teach
people that while sepsis starts with vague symptoms, it’s a medical
To make sure the doctor
doesn’t overlook the possibility, “Ask, ‘Could this be sepsis?’” advised the
CDC’s Dr. Lauren Epstein.
Sepsis is more than an infection
called blood poisoning or a bloodstream infection, sepsis occurs when the
body goes into overdrive while fighting an infection, injuring its own
tissue. The cascade of inflammation and other damage can lead to shock,
amputations, organ failure or death.
It strikes more than
1.5 million people in the United States a year and kills more than 250,000.
Even a minor infection
can be the trigger. A recent CDC study found nearly 80 percent of sepsis
cases began outside of the hospital, not in patients already hospitalized
because they were super-sick or recovering from surgery.
There’s no single symptom
In addition to symptoms
of infection, worrisome signs can include shivering, a fever or feeling very
cold; clammy or sweaty skin; confusion or disorientation; a rapid heartbeat
or pulse; confusion or disorientation; shortness of breath; or simply
extreme pain or discomfort.
If you think you have
an infection that’s getting worse, seek care immediately, Epstein said.
Doctors have long known
that rapidly treating sepsis is important. But there’s been debate over how
fast. New York mandated in 2013 that hospitals follow “protocols,” or
checklists, of certain steps within three hours, including performing a
blood test for infection, checking blood levels of a sepsis marker called
lactate, and beginning antibiotics.
Do the steps make a
difference? Seymour’s team examined records of nearly 50,000 patients
treated at New York hospitals over two years. About 8 in 10 hospitals met
the three-hour deadline; some got them done in about an hour. Having those
three main steps performed faster was better - a finding that families could
use in asking what care a loved one is receiving for suspected sepsis.
Who’s at risk?
Sepsis is most common
among people 65 and older, babies, and people with chronic health problems.
But even healthy people
can get sepsis, even from minor infections. New York’s rules, known as
“Rory’s Regulations,” were enacted after the death of a healthy 12-year-old,
Rory Staunton, whose sepsis stemmed from an infected scrape and was
initially dismissed by one hospital as a virus.
Illinois last year
enacted a similar sepsis mandate. Hospitals in other states, including Ohio
and Wisconsin, have formed sepsis care collaborations. Nationally, hospitals
are supposed to report to Medicare certain sepsis care steps. In New York,
Rory’s parents set up a foundation to push for standard sepsis care in all
“Every family or loved
one who goes into a hospital, no matter what state, needs to know it’s not
the luck of the draw” whether they’ll receive evidence-based care, said
Rory’s father, Ciaran Staunton.