New FDA Commissioner Supports Abuse-Deterrent Opioids


It does not matter how someone uses prescription opioids, they can be dangerous and potentially lead to a deadly overdose. However, it could easily be argued that the greatest risk is associated with intravenous (IV) use; opioid addicts will crush their pills, mix the powder with water and inject. In order to combat the use of opioid narcotics in unintended ways, pressure was put on pharmaceutical companies to develop formulations of their painkillers that are harder to abuse – known as abuse-deterrent opioids.

Critics of such efforts argue that harder-to-abuse painkillers are merely a band-aid, and have little effect on the opioid epidemic. While the new formulations are more difficult to use, addicts often find their way around tamper resistors and/or turn heroin as a cheaper, stronger alternative. Nevertheless, such arguments can easily be countered with ‘anything is better than nothing.’

The U.S. Food and Drug Administration (FDA) has a new commissioner who has vowed to support abuse-deterrent opioid efforts, the Associated Press reports. Dr. Robert Califf told a panel of FDA advisers that he is pledging to do “everything possible under our authority to prevent abuse, save lives and treat dependence.”

The new commissioner’s declaration is just one facet of an interagency effort to end the American opioid epidemic. However, Califf made clear that the FDA alone cannot resolve the current crisis, according to the article. Since 2010, Califf’s agency has approved five abuse-deterrent opioids, and there is reportedly another 20 such drugs in development. FDA Commissioner Califf plans to work with outside advisers and he has a comprehensive plan for addressing the prescription opioid scourge, which claims as many as 44 lives per day.

He stated that the agency will add more cautionary warning labels to the opioid narcotics prescribed the most, the article reports. What’s more, the FDA will encourage the safe disposal of unused medications, which will prevent narcotics from ending up in the wrong hands.

“What we can do is work with prescribers, professional associations, patient advocates and state and local partners — essentially the entire country — to encourage safe use and disposal of opioid medications,” said Califf. 

If you or a loved one struggles with prescription opioid and/or heroin addiction, please contact Harmony Foundation. We have been helping people break the cycle of addiction for decades, teaching people about the resources needed for a living a life on the road of recovery.

How Dangerous is Vaping?

e cigarette addiction

While most drugs are considered dangerous if abused, there are some that become more dangerous when they are masked as being “safe” because they are considered legal and less toxic than similar drugs.

This is the case for the abuse of prescription pills, which is now a national epidemic. Many adults, young adults and teens fell prey to prescription addiction by believing the drugs were safe because they were prescribed by a physician or FDA approved. People perceived that illegal drugs like cocaine or crystal meth were unsafe and prescription drugs were safe despite the comparable addictive qualities of both drug types.

This was also the case for synthetic drugs like bath salts and spice, especially among young adults who could easily purchase them at convenience stores. Many were under the false guise that these drugs were ok because after all, they didn’t even register on drug tests. Soon enough emergency personnel were reporting that these drugs were even more dangerous than commonly abused illegal drugs and their exact health consequences are still unknown.

Most recently the same debate has come up against vaping or e-cigarettes. Because e-cigarettes don’t contain the 60 plus carcinogens that regular tobacco smoke does, they have grown in popularity and perceived as the safer alternative with limited health consequences. Most vapor cigarettes are made with propylene glycol that the FDA has determined are generally safe. However, few know that these chemicals have been deemed safe for personal care products – not for inhaling. Also, few are aware that five minutes of vaping impairs lung function as much as smoking a regular cigarette.

A recent New York Times article outlined the dangers of the liquid nicotine in e-cigarettes, stating, “the key ingredients in e-cigarettes, are powerful neurotoxins. Tiny amounts, whether ingested or absorbed through the skin, can cause vomiting and seizures and even be lethal. A teaspoon of even highly diluted e-liquid can kill a small child.”

Because the e-liquids are not regulated by the FDA and legal to purchase, people don’t tend to consider their health liability and toxicologists fear that children are particularly at risk of being poisoned. In fact, there have already been several accidental poisonings reported with 1351 cases in 2013, many involving small children who innocently drink the chocolate or bubble gum flavored liquid sitting around the house. The e-liquid is considered more dangerous than tobacco because it is immediately absorbed. Children are not the only group at risk, as many adults have been admitted into hospitals for accidental ingestion. Recently a woman from KY was admitted to the hospital after e-cigarettes broke in her bed and was absorbed through her skin.

Often when addictive substances hit the market unregulated, it takes several poison control center or emergency room incidents to alert the FDA and public that health consequences exist. When addiction is in the driver’s seat, it is impossible for health to remain untethered despite substances being deemed or marketed as “safe” initially. We have observed this through treating all addictions at our Colorado rehab center and know that when it comes to addiction, there are always mental and or physical health consequences for the addict and loved ones.

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Drinking Energy Drinks in Recovery

Speculations about the harmful effects of energy drinks have been growing in recent years and the spotlight is now on Living Essentials, the company that makes Five Hour Energy drinks.

This week, the New York Times reported on the Food and Drug Administration’s investigation of 13 deaths and 32 hospitalizations blamed on the consumption of Five Hour Energy. The drink, which comes in a shot form, contains 215 milligrams of caffeine among other ingredients like taurine and phenylalanine. It is not clear yet if the deaths were a direct result of Five Hour Energy, as the FDA warned, “It is important to note that submitting a serious adverse event report to the FDA, according the agency itself, is not construed by FDA as an admission that the dietary supplement was involved, caused or contributed to the adverse event being reported.” Skeptics say it is improbable that the ingredients in Five Hour Energy were the culprit in the deaths or hospitalizations but studies have revealed the asscoiated health risks with consumption of such drinks.

Despite these reports, a growing sober trend is the consumption of energy drinks instead of alcohol when “going out” on the town – or going anywhere. While most energy drinks are banned from addiction treatment programs, many addicts in early recovery jump on the bandwagon of consuming copious amounts of Red Bull, Five Hour Energy shots and the like. Some hardliners say that these drinks are “mood altering” and therefore don’t support the code of abstinence. Others say that these drinks give them they energy they need while in post acute withdrawal, or for life in general, after years of bodily damage from which they are still recovering.

While physical recovery is a large part of recovery writ large, studies reveal that these drinks are doing little to help with recovery or with energy. In fact, there are known health risks associated with energy drinks that are antithetical to helping addicts recover, they include:

1.) Greater Risk of Drug Abuse and/or Relapse

According to a 2010 study in the Journal of Addiction Medicine, students who consumed energy drinks in the second year of college were at greater risk of prescription drug abuse, such as the use of stimulants like Adderall, in their third year of college. Similarly, for those in recovery from alcohol or drug abuse who consume energy drinks, the effects from ingredients like phenylalanine may mimic stimulants such as Adderall or cocaine, which may “trigger” them into using. For the addict, consumption of such drinks for chemically induced energy may not be “enough” and they become at risk of relapse.

2.) Impaired Cognitive Function

According to a Live Science article, energy drinks can impair cognitive function when consumed in excess. The study reports that while 40mg of caffeine improved student performance on a reaction test they were given, students who drank an excess of 80 mg, such as a can of Red Bull or shot of Five Hour Energy, had poorer performance on the same test.

Such studies are particularly important for those in early recovery to consider, especially those in post acute withdrawal whose cognitive functions are just beginning to heal. With the growing trend of people attending 12-Step meetings with super sized energy drinks in tow, they may want to consider how such drinks impact their recovery. It is no wonder many drug rehab centers have prohibited the consumption of such drinks, because while there is only speculation so far on the deaths from Five Hour Energy and other said detriments of energy drinks, it just isn’t worth the risk – especially when one is just re-starting their lives.