Black Box Warnings and Formulation Changes…


Black Box Warnings…

The FDA has made some changes to try and stem the flow of prescription drug abuse. One of their solutions, put a black box warning about the risk of abuse, addiction, overdose and death on drugs like oxycodone and fentanyl. Well that should help, right? I don’t think so. The FDA hopes that this will educate prescribers on how dangerous these drugs can be. I think prescribers already know how dangerous these drugs are.

For patients, the bottle in which they receive their prescription will have a notice that the drug has a black box warning. To see the warning, the patient will need to go to the manufacturers website. Pharmacists are encouraged, but not required, to provide a medication guide to patients, easy to understand information. Considering many prescriptions are filled by those seeking drugs for other than legitimate reasons, I do not see how such a warning will help. The prescriber surely must already know how dangerous such drugs can be. The patient may not, but most will not take the time to look up the black box warning online, or read provided literature. Especially those who are seeking the drug to get high.

Another solution…Hydrocodone was changed from Schedule III to Schedule II on 2014. This means a patient must have a written prescription to get the drug. Prescribers can no longer call the prescription in by phone. If a patient wants a refill, they must see their doctor again, no refills, only new prescriptions. This is good, but doesn’t go far enough.

Is the problem really that bad?

In 2014 nearly 48,000 people died from drug overdoses – 1 ½ times greater than the number killed in car crashes. Opioids are involved in over 60% of all drug overdose deaths. Over 40 people die each day from opioid overdose.

The biggest increase in deaths, 80%, was from synthetic opioids. According to the CDC, the increase in synthetic opioid deaths coincided with increased reports by law enforcement of illicitly manufactured fentanyl. Prescription painkillers such as oxycodone and morphine are derived from the same poppy plants as heroin. The majority of heroin abusers start by using prescription painkillers. Over a half a million lives have been lost from opioid abuse since the year 2000.

Another decent idea…

Did you know there are abuse-deterrent formulations of some opioids? These formulations make it more difficult to abuse the drugs. OxyContin is made more difficult to crush and subsequently inject. Suboxone, a sublingual (under the tongue) drug, is mixed with naloxone (or naltrexone, Narcan) so if it is injected, it will lose its clinical effect. Naloxone is not absorbed sublingually, but when the Suboxone is altered (for example, crushed) and injected, the naloxone becomes active thereby inactivating the Suboxone. They have done the same thing with oral morphine tablets and others drugs. If they are crushed and mixed with water to inject, the naloxone is activated and the narcotic effect eliminated. Another formulation has an added irritant, if it is crushed and snorted it hurts like the dickens. If it is mixed with a liquid, it forms an un-injectable gel. Another idea…mix meds with Niacin so when consumed in large doses the person experiences uncomfortable symptoms such as flushing, itching, sweating, chills and headache.

Some companies are developing drugs that have a slower delivery to the brain. This decreases the euphoria associated with these drugs and reduces the chance of overdose due to respiratory depression. No matter what someone does to the drug, crush, inject, chewing, there is no euphoric effect. What a great concept.

The FDA is encouraging studies of generic drugs that have abuse-deterrent formulations, good plan, but that will take years. We just don’t have that time.

I think these are great ideas and I love that companies are looking at alternatives to the current formulations of narcotics. Considering so many people start their addiction using prescription pain medication, I think the last idea of removing or minimizing the euphoric effect of the drugs is a fantastic idea. I hope this idea takes off and prescribers use these drugs first, not just for addicts, but the first time, and every time, a narcotic is prescribed for a patient. How many addictions could be prevented? If they are shown to be effective for pain control of course. Studies look promising so far.

What do you think?

About the Author

Kristin Waite-Labott is a registered nurse and recovering addict who has firsthand experience with the challenges of addiction. She now works as the Head Nurse Coach at Veritus, a virtual treatment program for nurses with substance use and mental health disorders, and is dedicated to helping nurses overcome addiction and making a difference in the lives of others. Kristin is passionate about addressing the growing problem of addiction among healthcare professionals and encourages open discussions and action to prevent it from spreading further.

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