Arixtra and Off Label Use

This page shows results related to Arixtra and Off Label Use from the FDA Adverse Event Reporting System (AERS).

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Arixtra and Off Label Use

Age

>60 Years	169
50-59 Years	26
20-29 Years	9
30-39 Years	8
40-49 Years	8
10-19 Years	1

Gender

Male: 41%
Female: 57%
Gender Unknown: 2%

Outcome

What were the most common outcomes of those reporting Off Label Use?

Hospitalization	161
Other	52
Death	40
Life Threatening	35
Disability	18

Reporter

Who most commonly reported Off Label Use?

Consumer	111
Physician	105
Pharmacist	15
Other	5
Lawyer	1

Therapy

Of those reporting Off Label Use, why were they taking Arixtra?

Atrial Fibrillation	55
Thrombosis Prophylaxis	49
Drug Use For Unknown Indication	15
Deep Vein Thrombosis	10
Heparin-induced Thrombocytopenia	5

Other Medications

Which medications reported to the FDA are most commonly associated with Off Label Use?

Seroquel	2483
Byetta	1488
Daytrana	1379
Nexium	1343
Zyprexa	898
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Seroquel Xr	722
Cymbalta	665
Vyvanse	510
Prograf	454
Symbicort	431
Fosamax	341
Prevacid 24 Hr	336
Optimark	335
Voltaren	311
Forteo	307
Ortho Evra	294
Risperdal	285
Doxorubicin Hcl	278
Erlotinib Hydrochloride	248
Tracleer	242
Humira	240
Arixtra	237
Crestor	230
Duragesic-100	217
Benadryl	206
Suboxone	200
Plavix	183
Tacrolimus	156
Prilosec	154
Rebif	153
Multaq	151
Methotrexate	136
Etoposide	134
Cytotec	123
Toprol-xl	123
Vincristine	119
Gemzar	116
Velcade	116
Cisplatin	116
Benefiber W/ Wheat Dextrin	116
Pulmicort Flexhaler	116
Pulmicort	114
Alimta	110
Actiq	107
Privigen	104
Olanzapine	104
Magnevist	102
Cyclophosphamide	101
Stelara	99
Risperidone	98
Zyrtec	93

Is the adverse drug reaction you’re experiencing actually due to the drug you took?

The Naranjo Scale is a questionnaire for determining the likelihood of whether an adverse drug reaction is actually due to the drug or caused by other factors. Probability is assigned via a score termed definite, probable, possible or doubtful.^*

	YES	NO	UNKOWN
Are there previous conclusive reports on this reaction?
Did the adverse event appear after the suspected drug was administered?
Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered?
Did the adverse reaction reappear when the drug was readministered?
Are there alternative causes (other than the drug) that could on their own have caused the reaction?
Did the reaction reappear when a placebo was given?
Was the drug detected in the blood (or other fluids) in concentrations known to be toxic?
Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?
Did the patient have a similar reaction to the same or similar drugs in any previous exposure?
Was the adverse event confirmed by any objective evidence?

Probability of an Adverse Event

Doubtful

Possible

Probable

Definite

^*Naranjo, et al. "A method for estimating the probability of adverse drug reactions." Clin Pharmacol Ther. 1981 Aug;30(2):239-45.

To learn more about all adverse events for Arixtra, view the complete Arixtra adverse event report.

Scientific Publications on Off Label Use

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