FDA OKs New Packaging for OTC Loperamide to Help Stem Misuse, Abuse
https://www.medscape.com/viewarticle/918786
In its ongoing effort to stem misuse and abuse of loperamide (Imodium, Johnson & Johnson), the US Food and Drug Administration (FDA) has approved changes to the packaging for brand-name, over-the-counter (OTC) tablet and capsule formulations of the opioid-based antidiarrheal medication.
The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules limit each carton to no more than 48 mg of loperamide and require the tablets and capsules to be packaged in individual (unit-dose) blister packs, according to an FDA safety communication.
The maximum approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day for prescription use. Abuse and misuse of loperamide is an ongoing problem in the US, the FDA said, with some individuals taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.
“The FDA has worked with manufacturers to approve package size limitations and unit-dose packaging for certain over-the-counter loperamide products. These changes are intended to increase the safe use of loperamide products without limiting over-the-counter access for consumers who use these products for their approved uses at the approved dose, according to labeling,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.
He said the agency is also asking online distributors to take “voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer.”
The FDA is also taking steps to ensure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.
In 2016, the FDA warned about life-threatening cardiac events, including QT interval prolongation, torsades de pointes or other ventricular arrhythmias, syncope, and cardiac arrest, with loperamide misuse and abuse, as reported by Medscape Medical News.
In 2017, the FDA added a warning to the product label about the risk of taking high doses of loperamide. They noted that some individuals are taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.
Also in 2017, the FDA added a Heart Alert warning to loperamide “drug facts” labels that warned consumers about the risks of taking higher-than-recommended doses.
The FDA said evidence suggests that package size limits and unit-dose packaging may reduce medication overdose and death.
In 2018, the agency asked manufacturers and packagers of OTC loperamide products to make these changes, as Medscape Medical News reported. Today, the FDA formally notified the public of these approved changes.
Filed under: General Problems
Because so many have been abandoned from their pain care there’s probably alot experiencing the effects of withdrawal which unfortunately includes diareah and not for just a day or two! I don’t believe anyone is abusing Imodium. Our government and its entities have found a new pet project and have lost their ever loving minds!
Actually there are individuals with substance use disorder who will take large amounts of “lope” to get through withdrawal.
Many people do not have access to medication assisted treatment and have limited options.
Someone that is an addict will use anything they can to get their high. Canned air, air conditioners stuff, glue, paint, gas, meth, crack, heroin, coke and anything else they can think up. What is the world supposed to do anymore, we can’t get rid of everything. When are these people going to wake up to what they are doing to themselves?
And when will we have to start signing for this like pseudophed? God forbid my family comes down with gastritis/diarrhea all at once. You used to be able to get Donnagel PG by signing for it and it worked wonders.
All this does is … once again … punish legitimate patients for the bad acts of criminals! There is a simple solution to the problem of addicts … let them suffer from the natural consequences of their actions!
You have to be kidding me. This sound like a perfect excuse to pay more for less pills and will not stop a addict from using them. People use for opiate withdrawal not because of the high ( if you are on a opiate already it is not strong enough to do any mind alter effects) but because they have lose bowels from withdrawal. I guess it would be better for addicts to have their runny stools disposed everywhere because they cannot make it to the toilet that is block away. Of course if these people had proper care and where taper safely then it would not be taken in large doses. This will not stop addiction. I am amazed they have not put limits on benadryl which can really screw people up especially with a little alcohol. All this will do is increase cost and make it harder for seniors to use the products. Meanwhile why don’t we spend money on teaching parent about the mental health needs of children because that is where the problem lies. Kids have worried we never dreamed of and the constant bombardment of negativity from the news, social media ect. 1st grader in some states get no PE or playtime so they do not get proper socialization and learning behavior of getting along with peers, no exercise which is just as important as learning is ( learning for children is much better when they feel safe, secure, love and feel that they have a purpose in life. Instead parents seem to think Tv and video games will be enough. We are not teaching children how to learn to do things on there own or to even use there own brain. Just ask a teen who lived in town for 10 years where a street is that is just one block over and they will pull out there cell phone first. We need to see life as a map. Plenty of directions you can go and choices to get there. But without proper planning you never leave the house. To many children never really develops the skills needed to live a happy life. While money may help with worries like not having enough food ect but it does not buy happiness and sometime distracts people to become slaves to that money instead of viewing life as a experience and how well it goes is on the decisions we make throughout our lives. One of the best things you can teach yourself and your children is people do not make you made. You let them. Getting help with mental health issues should not be looked as a weakness but the same as stigma as if the has a physical illness.
I totally agree
do you suppose these idiots will ever figure out that they can’t legislate addiction away?
I doubt it, myself. They seem learn-proof.
Oh yeah that’s going to stop anyone intent on misusing it!!