Drugs
with Multiple FDA Safety Alerts
BEVACIZUMAB
-
Reversible
posterior leukoencephalopathy syndrome (RPLS) (Sept
2006) (read comments)
-
FDA
Safety Alert: Tracheoesophageal fistula (4/2007)
BUPROPION HYDROCHLORIDE
-
Worsening
depression and suicidality associated with
antidepressants (March 2004)
-
FDA Safety
Alert : Review of data in adults (July 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
CELECOXIB
-
FDA NSAID Drug
Information Update Page (June 2005)
-
Bextra voluntarily withdrawn from market (April 7, 2005)
-
NSAID
Patient Medication Guide (June 2005)
CITALOPRAM HYDROBROMIDE
- Worsening
of depression and suicidality associated with antidepressants
(March 2004)
- FDA
Safety Alert: Suicidality in adults (June 2005)
- Health
Care Professionals and Patient Information Sheets (July 2005)
- FDA
SAfety Alert: Serotonin Syndrome with Triptans (November 2006)
- FDA
SAfety Alert: Use in Pregnancy (July 2006)
CLOZAPINE
-
Dear
Health Professional Letter (January 2006)
-
FDA safety
alert: Risk of diabetes, hyperglycemia (April 2004)
-
FDA
Safety Alert: Increased mortality in elderly with dementia (April 2005)
DICLOFENAC SODIUM
-
FDA NSAID Drug
Information Update Page (June 2005)
-
NSAID
Patient Medication Guide (June 2005)
DULOXETINE
-
Serotonin
Syndrome with Triptans (November 2006)
ENOXAPARIN SODIUM
-
Not recommended for thromboprophylaxis
in patients with prosthetic heart valves (2/28/02)
ESCITALOPRAM
-
Worsening
depression and suicidality associated with
antidepressants (March 2004)
-
Review of Data
in Adults (July 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
-
FDA Safety
Alert: Serotonin Syndrome with Triptans (November
2006)
-
FDA Safety
Alert: Use in Pregnancy (July 2006)
-
FDA Safety Alert
Caution: Unsafe to purchase over the internet (2/07)
FLUOXETINE HYDROCHLORIDE
-
Worsening
depression and suicidality associated with
antidepressants (March 2004)
-
FDA Safety
Alert: Suicidality in adults (June 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
-
FDA Safety
Alert: Serotonin syndrome with triptans (November
2006)
-
FDA Safety
Alert: Use in Pregnancy (July 2006)
FLUVOXAMINE MALEATE
-
Worsening
depression and suicidality associated with
antidepressants (March 2004)
-
FDA Safety
Alert : Review of data in adults (July 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
-
FDA Safety
Alert: Serotonin syndrome with triptans (November
2006)
IBUPROFEN
-
FDA NSAID Drug
Information Update Page (June 2005)
-
NSAID
Patient Medication Guide (June 2005)
-
FDA
Safety Alert: New safety data regarding concomitant use with aspirin (Sept
2006)
INDOMETHACIN
-
FDA NSAID Drug
Information Update Page (June 2005)
-
NSAID
Patient Medication Guide (June 2005)
ITRACONAZOLE
-
Risk of
CHF, new interaction data (5/9/01)
-
FDA Safety
Alert: Drug Interaction with replaglinide (Sept 2003)
LAMIVUDINE AND ZIDOVUDINE
-
FDA
Safety Alert: Misbranding of Ziagen tablets as Combivir tablets
LAMOTRIGINE
-
Safety Alert:
Dispensing Errors (Lamictal vs. Lamisil)
(12/6/01)
-
FDA
Safety Alert: Use in Pregnancy Risk (Sept 2006)
MIRTAZAPINE
-
Worsening
depression and suicidality associated with
antidepressants (March 2004)
-
FDA Safety
Alert : Review of data in adults (July 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
NAPROXEN
-
FDA NSAID Drug
Information Update Page (June 2005)
-
FDA Safety Alert:
Increased risk of cardiovascular events (Dec 2004)
-
NSAID
Patient Medication Guide (June 2005)
NEFAZODONE
-
Potential for
dispensing error: Serzone vs
Seroquel (Feb 2003)
-
FDA Safety
Alert : Review of data in adults (July 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
OLANZAPINE
-
Risk of diabetes,
hyperglycemia
-
Zyprexa
incorrectly dispensed for Zyrtec
-
FDA
Safety Alert: Increased mortality in elderly with dementia (April 2005)
ASPIRIN-OXYCODONE
-
New
safety data associated with concomitant use with ibuprofen (Sept 2006) (read
comments)
-
Company
Misrepresented Prescription Pain Reliever (5/07)
PAROXETINE HYDROCHLORIDE
-
Worsening
depression and suicidality associated with
antidepressants (March 2004)
-
FDA
Safety Alert : Review of data in adults ( MAy 2006)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
-
FDA Safety
Alert: Serotonin syndrome with triptans (November
2006)
-
Use in
pregnancy (July 2006)
QUETIAPINE FUMARATE
-
Med errors:
confusion with serzone and seroquel
(12/02)
-
FDA
Safety Alert: Increased risk of hyperglycemia, diabetes (April 2004)
-
FDA
Safety Alert: Increased mortality in elderly with dementia (April 2005)
RISPERIDONE
-
Cerebrovascular adverse events in elderly with dementia
related psychosis
(4/03)
-
FDA Safety Alert
Value Increased risk of hyperglycemia (July 2004)
-
FDA
Safety Alert: Increased mortality in elderly with dementia (April 2005)
SERTRALINE
-
Review of data
in adults (july 2005)
-
FDA
Safety Alert: Worsening depression and suicidality
(March 2004)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
-
FDA Safety
Alert: Serotonin Syndrome with Triptans (November
2006)
-
FDA Safety
Alert: Use in pregnancy (July 2006)
TRAZODONE HYDROCHLORIDE
-
Interactions
with CYP34A inhibitors (May 2004)
VENLAFAXINE HYDROCHLORIDE
-
Safety
Labeling Update: Change in Overdose Information (October 2006)
-
FDA Safety
Alert : Review of data in adults (July 2005)
-
Health
Care Professionals and Patient Information Sheets (July 2005)
-
FDA Safety
Alert: Serotonin Syndrome with Tritpans (November
2006)
ZIPRASIDONE
-
Information on drug
interactions (2/02)
-
FDA Safety
Alert Value Increased risk of hyperglycemia (August 2004)
-
FDA
Safety Alert: Increased mortality in elderly with dementia (April 2005)
ISOTRETINOIN
ROSIGLITAZONE
MALEATE AND GLIMEPIRIDE Tablets
ROSIGLITAZONE
MALEATE AND METFORMIN HYDROCHLORIDE
PIMECRLIMUS
MIFEPRISTONE
NORELGESTROMIN/ETHINYL ESTRADIOL
PROMETHAZINE HYDROCHLORIDE
TACROLIMUS
NATALIZUMAB
VALDECOXIB
-
Click here
for 2005 posted 6/2005
-
Click here
for 2005 posted 4/2005
ROSUVASTATIN
FENTANYL TRANSDERMAL SYSTEM
GALANTAMINE HYDROBROMIDE
ATOMOXETINE
ROFECOXIB
-
Click here
for 2005 posted 6/2005
-
Click here
for 2005 posted 4/2005
NEVIRAPINE
ZOLEDRONIC ACID
-
Click here
for 2005 posted 5/2005
-
Click here
for 2005 posted 3/2005