New Prescribing Information Released for Hundreds of FDA-Approved Opioids
As a country we put warning labels on tobacco products in the early 60’s and we still have 35 million Nicotine addicts and some 450,000 dying every year from the use/abuse of Nicotine… There are no WARNING LABELS on the drug Alcohol which we have 45 million alcoholics and in 2016 the death rate from the use/abuse of Alcohol exceeded 100,000 for the first time … abt a 20% increase over 2015. I guess that some parts of our bureaucracy just keeping doing the same thing over and over again and expecting a different outcome.. Most of us know Einstein’s option of that behavior.
Throughout 2016, we at the FDA have announced requirements for manufacturers to create new product labeling information for a variety of opioid medications.
These safety labeling changes are all effective as of Dec. 16, 2016.
A wide range of products, across virtually all opioids, will have some form of new labeling information. Here are the highlights of the new requirements.
• A new boxed warning for immediate-release (IR) opioids about the serious risks of misuse and abuse, which can lead to addiction, overdose and death (announced March 22, 2016). The updated labeling clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., nonopioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient. This action also included several additional changes across all prescription opioid products also addressing the risk of these medications.
• Safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder (announced May 26, 2016). This new labeling addresses a key concern over neonatal opioid withdrawal syndrome (NOWS), which can be effectively managed, but may be life-threatening if not recognized and treated. Our action requiring safety labeling changes for MAT-only methadone and buprenorphine products informs prescribers about the risks for NOWS without inadvertently discouraging treatment for pregnant women with opioid addiction.
• Classwide changes to drug labeling to include information about the serious risks associated with the combined use of certain opioid medications and benzodiazepines (announced Aug. 31, 2016). This includes boxed warnings and requirements for patients to receive Medication Guides when they get their prescriptions. Serious risks from combined use include extreme sleepiness, respiratory depression, coma and death. Among other important information, these labeling changes encourage prescribers to use the lowest effective dose over the shortest duration of time necessary if analgesic opioids and benzodiazepines must be used concurrently. Additionally, the labeling says that opioid cough syrups should never be used simultaneously with benzodiazepines. Of note, labeling for all of the affected benzodiazepine products will also be effective on Dec. 16, 2016.
When the FDA requires new product labeling, manufacturers are given time to meet the requirements and submit the new labeling information to the FDA for approval. For regulatory efficiency, and for a smoother transition of information for stakeholders, including prescribers, the FDA arranged to have all of these separately required changes to be effective on the same date.
The updated labels are an important part of the FDA’s continuing effort to educate patients and prescribers about the risks related to prescription opioids, including the importance of balancing the benefits and risks for each individual patient and emphasizing information important for appropriate patient selection.
Filed under: General Problems
I have not seen-read, anything regarding the harm, and dangerous effects of stopping antidepressant drugs such as Wellbutrin, Prozac, Celexa, Remeron, Cymbalta, . . . these over-prescribed, and Addictive medications have harmed & killed many, [but there aren’t any #s on these].
It is a crime that the medications proven to be of value, have been the ones taken off the market, and /or “freakishly-reconfigured”.
Ambien, for example, was a godsend for people with Fibro myalsia, until it went out of patent, making-it both unrecognizable and totally ineffective.
It must Be Government Control, because effectiveness, and popularity is what makes a drug financially lucrative. With all of the derogatory propaganda, sales of effective drugs, [as-well as $, and stigma, will hurt drug manufacturers, as the commons will give-up and reputation will damage any further action towards receiving these medications.
When government employees quit drinking, things will change, requiring alcohol bottles to carry warning labels. (I heard that in a dream I had.) When their cocktail parties stop serving drinks… When alcoholics realize they need treatment… It’s about the money, of course, and the recreation, of course.