First Single-Ingredient
Hydrocodone Drug Receives FDA Approval
The Food and Drug Administration on Friday approved the
first pure hydrocodone drug in the United States. The drug, Zohydro ER
(extended release), was approved for patients with pain that requires daily,
around-the-clock, long-term treatment that cannot be treated with other drugs.
Drugs such as Vicodin contain a combination of hydrocodone and other
painkillers such as acetaminophen, the Associated Press reports. In December, a
panel of experts assembled by the FDA voted against recommending approval of Zohydro
ER. The panel cited concerns over the potential for addiction. In the 11-2 vote
against approval, the panel said that while the drug’s maker, Zogenix, had met
narrow targets for safety and efficacy, the painkiller could be used by people
addicted to other opioids, including oxycodone. Patient safety advocates
criticized the FDA’s decision. “We’re just going to kill more kids and then the
FDA is going to come back and say, ‘oh, we made a mistake,’” said Avi Israel,
whose son Michael committed suicide while struggling with painkiller addiction.
Israel is the founder of a group that aims to combat painkiller abuse in young
people. In a statement, the FDA noted, “Zohydro ER will offer prescribers an
additional therapeutic option to treat pain, which is important because
individual patients may respond differently to different opioids.” The agency
will require postmarketing studies of Zohydro ER to evaluate the known serious
risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and
death associated with long-term use beyond 12 weeks.
Treating Trauma and
Addiction in Health Care Professionals
Health care professionals who are dealing with substance use
disorders face particular challenges, according to the executive director of an
organization dedicated to serving this population. These professionals must
learn to cope with the emotional challenges of having ready access to
medications, says Maureen Sullivan Dinnan, J.D. of HAVEN. “The disease of
addiction is the same for everyone, but for health care professionals, relapse
prevention strategies need to be different because of their access to drugs,”
she says. “They need to be prepared to deal with how they will feel when they
administer medication and see the patient’s pain is relieved, while they are
also suffering emotional or physical pain.” As with many other people, health
care professionals who abuse drugs often do so not to get high, but to
self-medicate to help them deal with having suffered trauma, Dinnan says. “When
their coping mechanism is taken away, they may lapse because they have no other
way to deal with the trauma.” Her Connecticut-based organization is holding a
symposium on Trauma and Recovery for health care professionals on November 1 at
Quinnipiac University in North Haven. HAVEN is a voluntary confidential
assistance program for health care professionals facing the challenges of
physical illness, mental illness, chemical dependence or emotional disorder. It
is designed as a peer-based process to encourage early identification of health
care professionals who are at risk for impairment. The program helps health
care professionals manage their own well-being in addition to the well-being of
their patients. “Over the last decade there has been a growing understanding
that if health care professionals don’t get care for themselves, it not only
hurts them, but may impact the quality of care they can deliver,” Dinnan says,
adding there is a misperception that health care professionals are stronger or
more able-minded than other people, and are therefore better equipped to deal
with the consequences of trauma. HAVEN has a high success rate that is due in
large part to the monitoring they conduct, according to Dinnan. “We make sure
if the person’s plan requires therapy, that they are engaged in therapy, and if
a person doesn’t commit to therapy, we are notified.” The program also conducts
random drug testing. They partner with a workplace monitor who is aware of the
health care professional’s treatment, and can notify HAVEN if the person
appears stressed and needs extra support.
Doctors Try New
Non-Narcotic Approach to Pain Management After Surgery
Doctors are trying a new approach to pain management after
surgery, in an attempt to reduce patients’ reliance on narcotic painkillers,
according to The Wall Street Journal. This “multimodal” approach includes
cocktails of medications given to patients before, during and after surgery.
The medication is delivered orally, intravenously and through injection into
the tissues and nerves around the surgical site. By avoiding giving patients
heavy doses of opioids, doctors hope to prevent the risk that patients will
become addicted to painkillers. They also avoid the grogginess, nausea, hallucinations
and constipation that can result from taking opioids. Martin Clark Jr., an
orthopedic surgeon at Sharon Hospital in Sharon, Connecticut, says when his
patients rely entirely on narcotics, they are “drowsy and apathetic, they
aren’t into physical therapy and they sit in bed.” In contrast, patients being
treated with the new pain protocols are more able to stick with physical
rehabilitation regimens to regain muscle strength and range of motion. Patients
undergoing knee replacement surgery at Canton-Potsdam Hospital in Potsdam, New
York, receive medication before surgery including the anti-inflammatory
Celebrex, and Lyrica, which treats nerve pain and blocks pain impulses to the
central nervous system. During surgery, patients receive anesthesia in the
lower spine, as well as a sedative, intravenous Tylenol and an anti-nausea
medication. The anesthesia lasts up to 24 hours after surgery. The surgeon also
injects medications into the tissues around the knee, including a numbing
agent, a drug to control bleeding and another anti-inflammatory agent. Once
patients are in recovery, they receive a continuous cooling pad to decrease
swelling and stimulate nerve endings, which reduces pain. They receive 24 hours
of intravenous Tylenol and more Celebrex and Lyrica. Patients are given oral
narcotics such as oxycodone, but they generally don’t need them for more than
two weeks, and often stop taking them after several days.
A Year After Federal
Legislation Bans Synthetic Drugs, More Than 250 Types Still Sold
A little more than a year after President Obama signed
legislation banning the sale of 26 designer drugs, more than 250 types of these
synthetic drugs are still sold in the United States, Roll Call reports.
Legislators and law enforcement agencies are trying to keep up with drug
makers, who are continually introducing slight variations of their products to
keep one step ahead of the law. They say the federal law was an important step
in fighting designer drugs, but it was not enough. “A change of a molecule or
two to a banned drug is sometimes enough to make a new and legal alternative,”
said Senator Charles E. Grassley of Iowa during a recent hearing of the Senate
Caucus on International Narcotics Control, of which he is co-chairman. After
the law was passed, law enforcement officials saw a slight reduction in calls
to poison control centers and visits to emergency rooms related to synthetic
drugs. Usage appears to be on the rise once again as drug manufacturers
continue to modify their products. Legislators are introducing more bills to
stem the tide, but it is unclear what Congress can do to help law enforcement
battle these drugs, the article notes. Synthetic drugs are popular because they
are easily available and less detectable by standard drug tests. Users may
incorrectly assume these drugs are less harmful than regular drugs. Joseph
Rannazzisi, Deputy Assistant Administrator of the Drug Enforcement
Administration’s (DEA) Office of Diversion Control, told senators at the
hearing, “DEA is constantly behind the clandestine chemists and traffickers who
quickly and easily replace newly controlled substances with new, non-controlled
substances.” He noted from January to August 2013, poison control centers
received 1,821 calls regarding exposures to synthetic marijuana. Because
synthetic drugs are unregulated, users don’t know what they are actually
getting when they buy the products in gas stations or online, Rannazzisi said.
Epilepsy Medication Could
Help Treat Cocaine Dependence: Study
The drug topiramate, used to treat epilepsy and migraine
headaches, may be an effective treatment for cocaine dependence, a new study
suggests. There are currently no medications approved by the Food and Drug
Administration to treat cocaine addiction, Science Daily reports. The study was
conducted by Dr. Bankole A. Johnson of the University of Maryland School of
Medicine, who previously found topiramate was a safe and effective treatment
for alcohol dependence. The new study, published in JAMA Psychiatry, included
142 adults who were seeking treatment for cocaine dependence. They were
randomly assigned to receive either topiramate or a placebo. The researchers
found topiramate was more effective at increasing the likelihood that
participants would have cocaine-free weeks. The drug was also significantly associated
with a decrease in cocaine craving, and an improvement in participants’ overall
functioning. Side effects of the drug were mild, and included abnormal tingling
skin sensations, taste distortions, anorexia, and difficulty concentrating.
“Our findings reveal that topiramate is a safe and robustly efficacious
medicine for the treatment of cocaine dependence, and has the potential to make
a major contribution to the global health crisis of addiction,” Dr. Johnson
said in a news release. “However, topiramate treatment also is associated with
glaucoma, and higher doses of the drug can increase the risk of side effects;
therefore, caution must be exercised when prescribing the drug, especially when
given in high doses.” A study published in July 2013 found topiramate may help
reduce cocaine use in people addicted to cocaine and alcohol.
Why doesn't alcohol have
nutrition labels?
A recently proposed change could mean uniform nutritional
labels across all consumable goodies (including booze).
How much fiber is in your shot of Jim Beam? What vitamins
are in your gin? If those questions sound odd, get ready: The same nutritional
information you see on Gatorade may soon be coming to raspberry vodka. It turns
out the government has different regulatory bodies for food and spirits, but a
recently proposed change could mean uniform nutritional labels across all
consumable goodies (including booze). It all stems from some fairly complicated
legal designations that separate food (headed up by the FDA) from some, but not
all, alcohol (which is regulated by the Department of the Treasury's Alcohol
and Tobacco Tax and Trade Bureau). Continue
reading here.
Study finds about 20% of
Md. college students show signs of alcohol abuse or dependency
A new report has found that about 19 percent of underage and
22 percent of college students ages 21 to 24 in Maryland show signs of alcohol
abuse or dependency. The report was done by a collaborative of Maryland's
higher education institutions that have joined forces to address excessive
drinking in college. The University System of Maryland and the Bloomberg School
of Public Health at the Johns Hopkins University have formed a coalition of 10
college presidents from across the state to establish the Maryland
Collaborative to Reduce College Drinking and Related Practices. According to a
new report issued by the group, Maryland college students drink at levels
similar to the national average, but its highest risk drinkers drink more than
their peers and are less likely to seek help. The report also found that nearly
one-third of Maryland college students drove under the influence of alcohol and
drugs. The coalition said Maryland colleges will be encouraged to develop
“multi-level” interventions at colleges where campus drinking occurs. Officials
said that while most Maryland schools offer alcohol programs and basic
training, the collaborative recommends going the extra step to help change
students’ behavior and “modifying the settings that influence students’
drinking decisions.”
New insights on college
drinking - Psychologists' research is pinpointing who is most at risk for
drinking problems in college and developing more targeted, evidence-based
interventions.
At the University at Albany in 2000, Chad Waxman fit the
profile of a college student primed for risky drinking: A freshman male
fraternity brother who drank in high school, Waxman chose Albany in part for
its balance between work and play. "I wanted that time to let loose,"
he says. Despite the predictors, Waxman sailed through college in health and
happiness, even serving in student government and winning multiple leadership
awards at the university before graduating in 2003. He went on to earn his
master's degree in counseling psychology and school counseling from Albany in
2005 and is now a PsyD candidate at Nova Southeastern University. How did
Waxman, now 33, avoid the pitfalls of drinking common among college students?
That's a question psychologists are probing deeply. After all, each year, more
than 1,825 college students die from alcohol-related accidents and nearly
600,000 are injured while drunk, according to a 2009 study in the Journal of
Studies on Alcohol and Drugs. Another 696,000 are assaulted by another student
who has been drinking, and 97,000 are victims of alcohol-related sexual assault
or date rape, the study found. Then there's the 25 percent of college students
who report academic consequences related to alcohol — a hangover can quickly
derail plans for class or study — and the 11 percent who admit damaging
property after a night of drinking (Journal of American College Health, 2002).
An estimated 5 percent get into legal trouble as a result of alcohol, the same
study found. In all, of the 80 percent of college students who drink alcohol,
half "binge drink," or consume about four drinks in two hours for
women and five in two hours for men, according to the National Institute on
Alcohol Abuse and Alcoholism (NIAAA). Click here to
read the full article.
FDA and Opioids: What's
Going On Here?
Against the recommendation of its own advisors, the U.S.
Food and Drug Administration approved a new high-dose narcotic painkiller, a
drug that the FDA concedes has a high risk for abuse and one which was using a
method that critics say may give the drug the appearance of greater efficacy.
Zohydro ER will be the first hydrocodone-only opioid, and it will come in doses
packing five to 10 times more heroin-like narcotic than traditional hydrocodone
products such as Vicodin that combine hydrocodone with over-the-counter pain
relievers such as acetaminophen or ibuprofen. Continue
reading here.
Study: 10% of Teens
Treated in the ER Admit to Misusing Prescription Drugs
Ten percent of 14- to 20-year-olds treated in the emergency
room for any reason say they have misused prescription drugs at least once in
the last year, a new study finds. The researchers at the University of Michigan
found most of the teens who admitted to misusing prescription drugs used other
people’s medications. Teens who misused prescription drugs were significantly
more likely to also have abused alcohol and non-prescription drugs such as
cough medicine, or to have used marijuana, in the past year, the study found.
They were also more likely to have ridden with a drinking driver. The findings
appear in the journal Pediatrics. The researchers say this is the first time
prescription drug abuse in teens has been studied in an emergency department
setting, even though opioid painkillers and sedatives are often prescribed by
emergency department doctors, PsychCentral reports. While school-based studies
have found rates of prescription drug misuse among young people to be around 8
percent, these studies do not include teens who have dropped out of school or
did not continue their education past high school, the article notes. Study
author Lauren Whiteside, M.D., said the findings suggest that emergency
departments could be an effective place to screen teens and young adults for
prescription drug misuse, and for intervening early before problems begin.
“These patients are often using the emergency department for their medical
care, not primary care settings,” she noted in a news release. “So, in order to
curb this problem and address overdose and addiction, the ED is a good place to
start.”
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