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Last Updated
November 26, 2014
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November 26, 2014
Additional Progress on Reducing Abuse of Opioid Pain Relievers
FDA’s approval of the extended-release opioid pain medicine Hysingla ER (hydrocodone bitartrate)
marks additional progress in the fight against the ongoing misuse and abuse of prescription
opioids.  Hysingla ER’s approval provides prescribers with another option for managing pain severe
enough to require daily, around-the-clock, long term opioid treatment in patients for whom
alternative treatment options are inadequate, while potentially reducing hydrocodone abuse.

In pre-approval testing, Hysingla ER exhibited properties that FDA expects will reduce the
likelihood users could abuse the drug by chewing the tablet and ingesting it orally, or crushing it
into powder for snorting or injecting. This is important because immediate-release combination
products containing hydrocodone are among the most frequently abused opioid products.  Hysingla ER
is the fourth prescription opioid approved with product labeling that is consistent with the FDA’s
2013 guidance on abuse-deterrent opioids. 

While Hysingla ER has the same active ingredient (hydrocodone) as Zohydro ER, the only other
approved extended-release hydrocodone product, there are important differences between the two.
Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not. Also, Zohydro ER is
taken every 12 hours, and so comes in lower dosage strengths than Hysingla ER, which is taken every
24 hours. FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER.

Notes Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA, “Prescription
opioids with abuse-deterrent properties will not completely fix the prescription opioid abuse
problem, but they can be part of a comprehensive approach to combat the epidemic. And the
development of abuse-deterrent opioids is only one of many elements of FDA’s overall approach,
which includes provider and patient education, close monitoring of approved opioids, and review and
approval of drugs to treat addiction and prevent overdose.” 

November 19, 2014
Smartphones Help Remind Teens To Take Their Meds
Data presented at the American Society of Nephrology meeting showed that half of adolescents and
young adult kidney disease patients with smartphones used their devices as a reminder to take their
medications and 30% used them to maintain their drug lists or dosing schedules. However, only 29%
were aware of medical mobile apps that could help them stick to their program. 

November 13, 2014
College Students -- Misuse & Abuse of Prescription Stimulants Becoming Normalized Behavior
A new, nationally representative survey released today by the Partnership for Drug-Free Kids
confirms that the abuse of prescription stimulants is becoming normalized among current college
students and other young adults. The online study found that young adults often misuse and abuse
prescription (Rx) stimulants as a way to manage the daily demands of academics, work and social
pressures. The survey is being released today at a panel discussion at New York University, hosted
by the Partnership for Drug-Free Kids and titled Under Pressure: College Students and the Abuse of
Rx Stimulants.  The new research found that 1 in 5 college students (20 percent) report abusing
prescription stimulants at least once in their lifetime, compared to 1 in 7 non-students (15
percent). Older students are also more prone to engage in these behaviors: the data found that
among current students, sophomores, juniors, seniors and graduate students are significantly more
likely to abuse Rx stimulants than college freshmen.

November 7, 2014
FDA: Consumers Advised to Avoid Mixing Dietary Supplements and Medications
The FDA is reminding consumers that mixing prescription and over-the-counter (OTC) medications with
vitamins, minerals, and dietary supplements can be dangerous because some supplements can influence
how the body absorbs the medicine. As a result, combining medicine and supplements could have
dangerous and even life-threatening effects, the agency notes.. The FDA also warns that children
could be particularly vulnerable to adverse events related to simultaneous use of supplements and
medication because metabolism rates change as they age.  FDA advises consumers who are adding a
dietary supplement or medication to their routine to first discuss the change with a doctor,
pharmacist, or other health care provider. En Español

November 7, 2014
Prescription Opioids Involved in Most ED Overdoses, Study Finds
Prescription opioid medications are involved in over 67% of overdose cases in emergency departments
(EDs), according to a national study published in JAMA Internal Medicine. 
The study,  Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments," 
also found that many patients who overdosed shared common coexisting illnesses, including chronic mental, 
circulatory, and respiratory diseases, meaning those who prescribe opioids to patients with these conditions 
"should do so with care and counsel the patients," a JAMA press release notes. 
The authors also indicated that the trends identified in this research can be a critical component for planning 
and implementing overdose prevention efforts, such as prescription monitoring programs and naloxone 
prescribing for at-risk patients.