[D66] FDA Black Box Warnings versus gele stickertjes

[René Oudeweg]

In Nederland heb je slechts kleine gele stickertjes op het 
medicatiedoosje "kan de rijvaardigheid beïnvloeden"...

In de VS heb je Black Box Warnings:

https://www.google.com/search?q=fda+black+box+warning&tbm=isch 
<https://www.google.com/search?q=fda+black+box+warning&tbm=isch>


Afbeelding



      *List of Black Box Warnings*!

*Drug/Drug Class* 	*Examples* 	*Warning*
*Antipsychotics* 	Quetiapine
Haloperidol
Olanzapine
Risperidone 	Increased mortality in older patients with dementia-related 
psychosis.
*Atypical antipsychotic* 	Clozapine 	Agranulocytosis
*Fluoroquinolones* 	Ciprofloxacin
Moxifloxacin
Levofloxacin
	Increased risk of tendon rupture/damage. This risk is heightened in 
elderly patients, and in those who take corticosteroids.
*SSRIs* 	Paroxetine
Fluoxetine
Sertraline
Fluvoxamine
Escitalopram 	Increased risk of suicidal ideation, particularly in 
younger patients. Same risk with most other antidepressants, such as SNRIs.
*Antiarrhythmic* 	Amiodarone 	Increased risk of pulmonary toxicity, 
hepatotoxicity, and heart block.
*Antimalarials* 	Mefloquine 	Increased risk of neuropsychiatric effects 
such as anxiety, depression, seizures, hallucinations, and loss of balance.
*Monoclonal antibody* 	Natalizumab 	Increased risk of progressive
multilocal leukoencephalopathy (PML).
*Progestins* 	Medroxyprogesterone 	Reduced bone density, particularly in 
premenopausal women. This effect is reversible once the medicine is 
discontinued.
*Fatty acids * 	Valproic acid 	Hepatotoxicity
Pancreatitis
*Opioids* 	Oxycodone
Morphine
Hydrocodone
Fentanyl
	Risk of addiction, misuse, abuse. Life-threatening respiratory depression.
*Long-acting beta-2* *agonists* 	Formoterol
Salmeterol 	Increased risk of asthma-related death. Should be used in 
combination with an inhaled corticosteroid such as fluticasone or 
budesonide.
*Sodium blockers* 	Carbamazepine
Lamotrigine 	Life-threatening skin reactions such as Stevens-Johnson 
syndrome, DRESS syndrome, and toxic epidermal necrolysis (TEN).
*Direct thrombin inhibitor* 	Dabigatran 	Blood clot formation that can 
cause permanent paralysis if the drug is injected into the patient’s 
spinal/epidural area; or have a spinal puncture.
*Xanthine oxidase inhibitor* 	Febuxostat 	Increased risk of serious 
cardiovascular events.
*Tyrosine kinase inhibitors* 	Nilotinib 	Increased risk of QT prolongation.
*Thiazolidinediones* 	Pioglitazone 	Increased risk of heart failure.
*Tetracyclines* 	Tigecycline 	Increased risk of death when given IV for 
serious infections such as ventilator-associated pneumonia and 
complicated intra-abdominal infections.
*IBS medicine* 	Linaclotide 	Increased risk of serious dehydration in 
children under 6-years. Linaclotide should be avoided in 6-18 years, too.
*Tyrosine kinase inhibitor* 	Cabozantinib 	Holes forming in the stomach 
(GI perforation), as well as the risk of GI fistulas.

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