The Black Box Warning Initiative

(Click HERE for a sneak peek into what 2020 holds for the BBWI)

OBJECTIVES

(aka the short answer)

 

  • Create awareness for FDA-issued BLACK BOX WARNINGS, specifically side-effects that are permanently disabling, debilitating, or fatal.

  • Enforce the AMA's call for the removal of prescription drug advertisements on television and in print ads.

  • Mandatory physician reporting on ALL PATIENT SUICIDES involving current or past prescriptions for medications with BLACK BOX WARNINGS---specifically warnings that  include "suicidal thoughts or actions," "suicide," "worsening depression," "restlessness," "worsening anxiety," "inability to hold still," or "akathisia." This prescriber mandate will apply whether the patient is a current or former patient. It's about gathering data we do not have on medications and their safety, not about patients.   

  • Allow for more face to face time between medical professionals and patients to encourage a more collaborative, informed, and empowering relationship between patient and healthcare provider. 

MISSION STATEMENT

(aka the longer answer)

Do you know what the SURGEON GENERAL’S WARNING is?

 

Of course you do. WHY IS THAT?

 

In 1969 and 1988, respectively, the Federal Government issued warnings on the hazards of using tobacco and alcohol products due to public-health awareness campaigns, which forced Congress to label these products. The goal was to assure consumers were informed of all the risks associated with using them before buying them. 

 

Do you know what the HARVARD ALCOHOL PROJECT is?

 

Yes, you do. WHY IS THAT?

 

Even if you’ve never heard of the HAP you know the results of their efforts through these two slogans/terms: 

 

“FRIENDS DON’T LET FRIENDS DRIVE DRUNK” & DESIGNATED DRIVER (OR “DD”)

 

These efforts were initiated and put in place with one goal in mind: to SAVE LIVES. And they did it by providing the public with INFORMATION on the risks associated with these products—risks that could potentially affect EVERYONE.

By labeling potential hazards, these important health campaigns did the following:

  • Changed how these products were advertised 

  • Forced accountability through increased clinical-research transparency

  • Stopped unethical research practices by opening research to public scrutiny 

  • Created and enforced laws against deceptive marketing practices that targeted children and young adults. 

 

What happened & did they work?

 

Yes. Here’s how:

  • Before the Surgeon General’s Warning was first issued on cigarettes, 46% of the adult population smoked.

  • The number declined to 18% fifty years after the first warnings.

  • The warning was so successful, the CDC listed the warning as one of the “…ten greatest public health achievements of the 20th Century.”

  • According to the CDC, over 1.6 million deaths were prevented between 1964 and 1992.

  • Before the HAP, alcohol-related traffic deaths were the #1 killer of young people ages 15-24 in the U.S. 

  • Within a decade, the death toll dropped by over 30%. It’s estimated over 50,000 lives were saved. 

 

Neither campaigns sought to eradicate the use of the products or threaten access to consumers or either industry.

 

What saved all those lives was INFORMATION.

 

WHAT ARE BLACK BOX WARNINGS (oftentimes called Boxed Warnings)?

  • BLACK BOX WARNINGS are the most serious warnings  required by the U.S. Food and Drug Administration (FDA) on already-FDA-approved medications on the market. INFORMATION everyone should have.

  • BLACK BOX WARNINGS are issued after the FDA has reasonable evidence* that the use of a medication has seriously adverse or life-threatening risks, effects, and contraindications associated with its use.

  • BLACK BOX WARNINGS have been issued for over 800+ FDA-approved medications** currently available to patients and prescribers.

  • BLACK BOX WARNINGS are for prescriber-directed use, not intentional misuse or abuse of the drug.

 

     WHAT IS THE BLACK BOX WARNINGS INITIATIVE?

The BLACK BOX WARNINGS INITIATIVE is a grassroots*** initiative to support the FDA’s mission to make medications safer for both consumers and prescribers by creating awareness for BLACK BOX WARNINGS .

 

WHAT ARE OUR GOALS ?

Besides the short answer, above:

  • To SAVE LIVES by creating awareness for BLACK BOX WARNINGS, making sure INFORMATION about medications with these warnings is known and accessible to both prescribers and patients, including but not limited to, clear accessible INFORMATION​ on:

    • how to identify adverse drug-reactions faster and accurately before they become serious or fatal

    • on ALL side-effects, risks, and contraindications so risks v. benefits are clear to patients and prescribers

    • on ALL possible and potential drug-interactions

  • Improve doctor-patient relationships through more collaborative, informed healthcare choices 

  • Join the American Medical Association’s (AMA) call for a ban on prescription drug advertising

  • Cultivate a more positive and trusting healthcare experience for both provider and patient

BLACK BOX WARNING INITIATIVE is: 

PRO-Information

PRO-Informed Choice

+ PRO-Patient-Safety

+ PRO-Healthcare Providers (who care about all the above--which is the majority of them) 

 

BLACK BOX WARNING INITIATIVE  iis NOT

X ANTI-Medication  X  ANTI-Physician  X  ANTI-Healthcare Providers (of any kind)

 

WHAT CAN YOU DO?

 

Simple. If you or a loved one are taking medications, ask your prescribing physician if any of them have BLACK BOX WARNINGS. Then ask how and where you can find them, too, because to make an INFORMED CHOICE, you must be INFORMED.

 

IT’S ABOUT SAFETY—FOR ALL OF US

DO YOU KNOW YOUR BLACK BOX WARNINGS?

                                       

*As of August 2019, we’ve been unable to find specific FDA-guidelines and/or criteria that constitute “reasonable evidence,” or a conclusive number of people who must be seriously or fatally harmed before a BLACK BOX WARNING is issued by the FDA. WHY IS THAT?  

**As of August 2019, the we’ve been unable to find a current or statistically accurate number of available medications that have been issued FDA  BLACK BOX WARNINGS. WHY IS THAT?  (Good question. As patients, healthcare providers and consumers, we want to know, too.)

***This is a not-for-profit grassroots initiative and is not affiliated with the Federal Food and Drug Administration in any official capacity.

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