Video: What if

From Adrenal Insufficiency United

A video about Adrenal Insufficiency and the need for emergency protocols.

An injection which costs about $10 could save a life.

Please help us make sure it’s available to all who need it.

 

FDA Puts Strict Limits on Oral Ketoconazole Use

By John Gever, Deputy Managing Editor, MedPage Today

SILVER SPRING, Md. — Oral ketoconazole (Nizoral) should never be used as first-line therapy for any type of fungal infection because of the risk of liver toxicity and interactions with other drugs, the FDA said Friday.

The agency ordered a series of label changes and a new medication guide for patients that emphasize the risks, which also include adrenal insufficiency. It noted that the restrictions apply only to the oral formulation, not topical versions.

Late Thursday, the chief advisory body for the FDA’s European counterpart went further. The EU’s Committee on Medicinal Products for Human Use (CHMP) recommended that member nations pull oral ketoconazole from their markets entirely.

Both the FDA and the CHMP cited studies indicating high risks of severe, acute liver injury in patients taking the drug. Studies using the FDA’s adverse event reporting system and a similar database in the U.K. indicated that liver toxicity was more common with oral ketoconazole than with other anti-fungals in the azole class.

The FDA also said that oral ketoconazole “is one of the most potent inhibitors” of the CYP3A4 enzyme. This effect can lead to sometimes life-threatening interactions with other drugs metabolized by CYP3A4, and also to adrenal insufficiency, since the enzyme also catalyzes release of adrenal steroid hormones.

“This accounts for clinically important endocrinologic abnormalities observed in some patients (particularly when the drug is administered at high dosages), including gynecomastia in men and menstrual irregularities in women,” the FDA said.

The only indication for oral ketoconazole still supported by the FDA is for use in life-threatening mycoses in patients who cannot tolerate other anti-fungal medications or when such medications are unavailable.

In such instances, the FDA said, physicians should assess liver function before starting the drug. It is contraindicated in patients with pre-existing liver disease, and patients should be instructed not to drink alcohol or use other potentially hepatotoxic drugs.

Adrenal function should also be monitored in patients using the drug.

The CHMP also indicated the topical formulations of ketoconazole should stay on the market, but it found no basis for keeping the oral form available for any purpose.

“Taking into account the increased rate of liver injury and the availability of alternative anti-fungal treatments, the CHMP concluded that the benefits did not outweigh the risks,” the panel indicated in a statement.

It recommended that physicians stop prescribing oral ketoconazole and that they should review alternatives in patients currently receiving the drug. The committee also said that patients now taking oral ketoconazole “make a non-urgent appointment” with their physicians to discuss their treatment.

From MedPage Today

Doctor’s Notes: Part 2, Adrenal

The adrenal glands sit atop the kidneys.

The adrenal glands sit atop the kidneys. (Photo credit: Wikipedia)

Acronyms or abbreviations for “Adrenal”

AD: adrenal vein
AG: adrenal gland
AdNA: adrenal gland
AC: adrenal cortex
adc: adrenal cortex
ADM: adrenal medulla
AA: adrenal adenoma
AF: adrenal failure
AM: adrenal medulla
AA: adrenal androgen
PA: pituitary-adrenal
AA: adrenal androgens
AAs: adrenal androgens
AM: adrenal medullary
LAV: left adrenal vein
AH: adrenal hypoplasia
AH: adrenal hemorrhage
AE: adrenal enucleation
AG: adrenal glomerulosa
AH: adrenal hyperplasia
HFA: human fetal adrenal
BAC: bovine adrenal cells
ADM: adrenal demedullation
AI: adrenal incidentaloma
AI: adrenal insufficiency
AVS: adrenal vein sampling
AI: adrenal incidentalomas
BAM: Bovine Adrenal Medulla
PAA: pituitary-adrenal axis
AMQD: Adrenal Move Quick Draw
AVS: Adrenal venous sampling
ach: adrenal cortical hormone
ACCs: adrenal chromaffin cells
AZF: adrenal zona fasciculata
BAM: Bovine adrenal medullary
PAL: Primary adrenal lymphoma
Ad4BP: Adrenal 4-binding protein
BAC: bovine adrenal chromaffin
ACC: adrenal cortical carcinoma
acca: adrenal cortical carcinoma
BAG: bovine adrenal glomerulosa
SAM: sympatho-adrenal-medullary
NAH: neonatal adrenal hemorrhage
PAH: primary adrenal hyperplasia
AHC: adrenal hypoplasia congenita
ACA: adrenal cortex autoantibodies
ACTH: adrenal corticotropic hormone
BAH: bilateral adrenal hyperplasia
CAH: congenital adrenal hypoplasia
HPA: hypothalamo-pituitary-adrenal
PAI: primary adrenal insufficiency
SAM: sympathetic-adrenal medullary
cah: congenital adrenal hyperplasia
HPA: hypothalamic-pituitary-adrenal
IAH: idiopathic adrenal hyperplasia
ACTH: adrenal corticotrophic hormone
ahc: adrenal hypoplasia, congenital
BAMC: bovine adrenal medullary cells
H-P-A: hypothalamic-pituitary-adrenal
HPA: hypothalamic-adrenal-pituitary
HPA: hypothalamus-pituitary-adrenal
HPAA: hypothalamic-pituitary-adrenal
IHA: idiopathic adrenal hyperplasia
LOAH: late-onset adrenal hyperplasia
NCAH: nonclassic adrenal hyperplasia
UAH: unilateral adrenal hyperplasia
BACC: bovine adrenal chromaffin cells
BACCs: bovine adrenal chromaffin cells
BCC: Bovine adrenal chromaffin cells
CAH: congenital adrenal hyperplasias
HHA: hypothalamo-hypophyseal-adrenal
BAC: bovine adrenal fasciculata cells
ARH: adrenal regeneration hypertension
HPAA: hypothalamo-pituitary-adrenal axis
ASNA: adrenal sympathetic nerve activity
HPA: hypothalamo-pituitary-adrenal axis
BAMC: bovine adrenal medullary chromaffin
FAH: Functional adrenal hyperandrogenism
HPA: hypothalamic-pituitary-adrenal axis
HPA-axis: hypothalamic-pituitary-adrenal axis
HPAA: hypothalamic-pituitary-adrenal axis
HPAA: hypothalamus-pituitary-adrenal axis
AASH: adrenal androgen stimulating hormone
BAME: bovine adrenal medullary endothelial
HPA: hypothalamus-pituitary-adrenal gland
NADF: National Adrenal Diseases Foundation
PAMC: porcine adrenal medullary chromaffin
CLAH: congenital lipoid adrenal hyperplasia
APA: aldosterone-producing adrenal adenoma
HPA: hypothalamic-pituitary-adrenal system
HPAT: hypothalamus-pituitary-adrenal-thymus
LHPA: limbic-hypothalamic-pituitary-adrenal
PCAI: primary chronic adrenal insufficiency
HHAS: hypothalamo-hypophyseal-adrenal system
HPA: hypothalamo-pituitary-adrenal cortical
HPA: hypothalamic-pituitary-adrenal cortical
RAMEC: rat adrenal medullary endothelial cells
CVAH: congenital virilizing adrenal hyperplasia
CAH: congenital virilizing adrenal hyperplasia
LOCAH: late-onset congenital adrenal hyperplasia
LHPA: limbic-hypothalamic-pituitary-adrenal axis
NC-CAH: non-classical congenital adrenal hyperplasia
AIMAH: ACTH-independent bilateral macronodular adrenal
pre-ASNA: preganglionic adrenal sympathetic nerve activity
AIMAH: ACTH-independent macronodular adrenal hyperplasia
CAHSA: Congenital Adrenal Hyperplasia Support Association
AIMAH: ACTH-independent bilateral macronodular adrenal hyperplasia

Have You Gone to the ER With an Adrenal Crisis?

This Survey is to gather information for the Adrenal Insufficiency Awareness Organization’s grant project to create educational materials for ER personnel.

The survey is for those of you who have been to the ER during an impending or full blown Adrenal Crisis. (you may fill it out for a child or yourself)

Your help is appreciated!

At the end of the survey you will have the chance to enter for a chance to win an Adrenal Insufficiency Awareness Pin.

https://www.surveymonkey.com/s/ERcare

From the CushieWiki: Personal Stories

Cushie Warriors

Personal Stories – Autumn

Personal Stories – Deb

Personal Stories – HockeyGirl

Personal Stories – Jessica

Personal Stories – Kate

Personal Stories – MaryO

Personal Stories – Staticnrg

All Personal experiences