FDA issues black box warning today for "z drugs"

some semi exciting news - the FDA issued a black box warning today for z-drugs.  doubt it will influence doctors much but its the first step in the agency acknowledging these meds are dangerous..... a small victory i suppose...... if they put a black box on the z drugs - what does that tell you about the benzos......

Nice find... here is the link to the article

Thanks for the heads up and also for the link. I'll make sure I never take these.

What does "black box" mean? (I am not from the US)

Good news! To be honest Ambien hit me much harder than benzos. I only took it once, so not sure about withdrawal comparison, but I was tripping hard on Ambien. It felt like salvia (hallucinogen). I never had it that strong with benzos. Xanax was somewhat similar, but to the much lesser extent. Neither Ativan or Klonopin did that to me.

Let’s hope they don’t suddenly pull everyone off of them...

Do benzos have black box warning?

👏The good ole’ FDA. Great work fellas 👏👏👏

What does "black box" mean? (I am not from the US)

 

Hi,

What is a black box warning on a prescription drug?

A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. It is basically a warning with a black box around it, hence the name. Having the black box around the warning means that an adverse reaction to the drug may lead to death or serious injury. It's based on clinical data or serious animal toxicity data in the absence of clinical data. Sometimes a black box warning is necessary at the time a new drug is approved. More commonly however, it is added after the drug has been approved and the FDA has received reports of adverse events. After the FDA confirms the serious risk, then depending on the severity of adverse event and in collaboration with the pharmaceutical company, a boxed warning is implemented.

This does not mean the drug is contraindicated in any way, but just a means of communication from the FDA to prescribers to highlight the risk. As with any drug, there is a risk and benefit associated with taking the drug. The black box warning is to alert prescribers of the potential risk in prescribing this drug so they can take it into consideration. If you have concerns regarding your prescription, discuss with your physician.

 

yes hope they don't pull it since am on it.

 

yes do benzos have it, too?

What does "black box" mean? (I am not from the US)

 

Hi,

What is a black box warning on a prescription drug?

A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. It is basically a warning with a black box around it, hence the name. Having the black box around the warning means that an adverse reaction to the drug may lead to death or serious injury. It's based on clinical data or serious animal toxicity data in the absence of clinical data. Sometimes a black box warning is necessary at the time a new drug is approved. More commonly however, it is added after the drug has been approved and the FDA has received reports of adverse events. After the FDA confirms the serious risk, then depending on the severity of adverse event and in collaboration with the pharmaceutical company, a boxed warning is implemented.

This does not mean the drug is contraindicated in any way, but just a means of communication from the FDA to prescribers to highlight the risk. As with any drug, there is a risk and benefit associated with taking the drug. The black box warning is to alert prescribers of the potential risk in prescribing this drug so they can take it into consideration. If you have concerns regarding your prescription, discuss with your physician.

 

Thank you very much - just found out that in Europe they use a "black triangle" to mark these meds. 

Sadly, z-drugs are not marked yet.

 

Zolpidem did some bad damages to me. I reacted paradoxical after a while and overall the withdrawal was very bizarre.

 

Thank you very much - just found out that in Europe they use a "black triangle" to mark these meds. 

 

 

And excitotoxicity occur from z-drugs?

When I was taking zolpidem, I had a bad habit of sleep cooking. Surprised I didn't burn the house down. It's been easier getting off clonazapam and ambien combined than it was zolpidem alone. Half my neighborhood is on either oxy or zolpidem, and I live in a nice neighborhood.