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Potential Signals of Serious Drug Risks: January – March 2008

September 7, 2008 · Filed Under Side Effect Facts · Comment 

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January – March 2008 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
January – March 2008


Product Name: Active Ingredient (Trade)
or Product Class		 Potential Signal of Serious Risk/New Safety Information
Arginine Hydrochloride Injection (R-Gene 10) Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane) Cardiac arrest
Duloxetine (Cymbalta) Urinary retention
Etravirine (Intelence) Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) Adverse events due to name confusion
Heparin Anaphylactic-type reactions
Icodextrin (Extraneal) Hypoglycemia
Insulin  U-500 (Humulin R) Dosing confusion
Ivermectin (Stromectol) and Warfarin Drug interaction
Lapatinib (Tykerb) Hepatotoxicity
Lenalidomide (Revlimid) Stevens Johnson Syndrome
Natalizumab (Tysabri) Skin melanomas
Nitroglycerin (Nitrostat) Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin) Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity) Cardiopulmonary reactions
Phenytoin Injection (Dilantin) Purple Glove Syndrome
Quetiapine (Seroquel) Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka) Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults

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FDA to Post Quarterly Report of Potential Safety Issues

September 7, 2008 · Filed Under Side Effect Facts · Comment 

The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA’s Adverse Event Reporting System (AERS).

The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency’s review of adverse event reports contained in AERS.

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

“My message to patients is this: Don’t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

Drugs that appear on the agency’s new AERS-based table, titled “Potential Signals of Serious Risks/New Safety Information,” are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report, posted to FDA’s Web site today, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA’s Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.

A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA’s Web site every three months.

“Over the past two years, FDA has become much more proactive in our communication about possible safety problems,” Woodcock said. “Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues.”

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FDA to Post Quarterly Report of Potential Safety Issues

September 5, 2008 · Filed Under Side Effect Facts · Comment 

The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA’s Adverse Event Reporting System (AERS).

The information is being provided under provisions of the Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007. The law requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency’s review of adverse event reports contained in AERS.

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.

“My message to patients is this: Don’t stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.

Drugs that appear on the agency’s new AERS-based table, titled “Potential Signals of Serious Risks/New Safety Information,” are identified by FDA reviewers based on reports from the FDA’s AERS database, which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients. For a drug to appear on this report, an FDA reviewer will have determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.

This first quarterly report, posted to FDA’s Web site today, lists 20 drugs along with the potential safety issue associated with each drug. Each quarter, a new report will be posted to FDA’s Web site listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS. The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.

A new quarterly report listing additional drugs for which new safety information or potential signals of serious risks have been identified through AERS will be posted to the FDA’s Web site every three months.

“Over the past two years, FDA has become much more proactive in our communication about possible safety problems,” Woodcock said. “Patients and health care professionals have told us that they want to be informed about possible safety problems sooner. They want to know when FDA is in the early stages of looking into a potential safety problem. Congress took note of this when it directed us to post this quarterly report of potential safety issues.”

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Zyrtec side effects: Excessive hair shedding

September 5, 2008 · Filed Under Zyrtec side effects · Comment 



Episode #75
Side Effect Date:2008-07-22
Symptoms:
Excessive hair shedding
Medication Name:
ZYRTEC
Diagnosis or Reason for Use:
Seasonal Allergies
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
I started taking Zyrtec around June 18 and the next week my husband noticed that I was shedding hair. I told him that happens every so often and it lasts about a week. This time it has not stopped and I have been losing more hair every week. After I wash and dry my hair I am counting over 500 strands of hair. I am now off zyrtec and I will have to wait and see the long term effects.
Medication dose: Zyrtec OTC 10 mg
Frequency of Use: once a day for 32 days
Other medications used at the time of event:
none
Other Relevant History, Including Preexisting Medical Conditions:

Patient’s Age at the time of event: 40
Patient’s gender: F
Patient’s weight at the timeof event:

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Zonegran side effects: Fever rash oral ulcer UTI

September 5, 2008 · Filed Under Zonegran Side Effects · Comment 



Episode #94
Side Effect Date:2008-08-01
Symptoms:
Fever rash oral ulcer UTI
Medication Name:
ZONEGRAN
Diagnosis or Reason for Use:
SEIZURES
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
Medication dose: 100 mg
Frequency of Use:

Other medications used at the time of event:
LEVITRACETAM
Other Relevant History, Including Preexisting Medical Conditions:
NO

Patient’s Age at the time of event: 24
Patient’s gender: F
Patient’s weight at the timeof event:

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Zicam side effects: “i can no longer taste food, it seems my taste buds are gone”

September 5, 2008 · Filed Under Zicam side effects · Comment 



Episode #67
Side Effect Date:2008-06-25
Symptoms:
“i can no longer taste food, it seems my taste buds are gone”
Medication Name:
ZICAM
Diagnosis or Reason for Use:
sore throat
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
no warning
Medication dose: 1 tablet melt in your mouth
Frequency of Use: every three or four hours
Other medications used at the time of event:
none
Other Relevant History, Including Preexisting Medical Conditions:
none

Patient’s Age at the time of event: 50
Patient’s gender: F
Patient’s weight at the timeof event:

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Vigamox side effects: “burning , extreme senstivity to light and blurred vision”

September 5, 2008 · Filed Under Vigamox Side Effects · Comment 



Episode #112
Side Effect Date:2008-08-20
Symptoms:
“burning , extreme senstivity to light and blurred vision”
Medication Name:
VIGAMOX
Diagnosis or Reason for Use:
post cataract surgery
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
MD discontinued medication
Medication dose: one drop left eye
Frequency of Use: 4 times daily for 1 week
Other medications used at the time of event:
Omnipred eye drops
Other Relevant History, Including Preexisting Medical Conditions:
none

Patient’s Age at the time of event: 57
Patient’s gender: F
Patient’s weight at the timeof event:

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Truvada side effects: top of stomach hurt it hurts to eat food

September 5, 2008 · Filed Under Truvada side effects · Comment 



Episode #56
Side Effect Date:2008-07-02
Symptoms:
top of stomach hurt it hurts to eat food
Medication Name:
TRUVADA
Diagnosis or Reason for Use:
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
Medication dose: kaletra 200 mg twice daily & truvda once daily
Frequency of Use: daily
Other medications used at the time of event:
Other Relevant History, Including Preexisting Medical Conditions:
none

Patient’s Age at the time of event: 51
Patient’s gender: F
Patient’s weight at the timeof event:

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Tri-nessa side effects: “Fatique, Depression, Anxiety, Vaginal Itch, Headaches, Cramping/bloating, Weight Loss “

September 5, 2008 · Filed Under Tri-nessa side effects · Comment 



Episode #64
Side Effect Date:2008-07-01
Symptoms:
“Fatique, Depression, Anxiety, Vaginal Itch, Headaches, Cramping/bloating, Weight Loss “
Medication Name:
TRI-NESSA
Diagnosis or Reason for Use:
Regulate my period.
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
Medication dose:
Frequency of Use:

Other medications used at the time of event:
None
Other Relevant History, Including Preexisting Medical Conditions:

Patient’s Age at the time of event: 30
Patient’s gender: F
Patient’s weight at the timeof event:

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Tisseel side effects: Mastoid pain and wound purulent drainage 4 days post-op skull base surgery for pulsatile tinnitus. Tisseel and teflon fibers used to separate cerebellar artery from auditory nerve.

September 5, 2008 · Filed Under Tisseel side effects · Comment 



Episode #54
Side Effect Date:2007-08-14
Symptoms:
Mastoid pain and wound purulent drainage 4 days post-op skull base surgery for pulsatile tinnitus. Tisseel and teflon fibers used to separate cerebellar artery from auditory nerve.
Medication Name:
TISSEEL
Diagnosis or Reason for Use:
Seal and separate teflon from the AICA and auditory nerve. Surgery was endoscopic.
Outcomes Attributed to Side Effect:
Death
Life-threatening
Hospitalization – initial or prolonged
Disability or Permanent Damage
Congenital Anomaly/Birth Defect
Required Intervention to Prevent Permanent Damage
Other Serious (Important Medical Events)
Describe Event, Problem or Product Use Error:
Enterobacter aerogenes bacterial meningitis with subdural abscess. Suspect contaminated batch of Tisseel.
Medication dose: Few CC mixed in OR by nurse
Frequency of Use: Once
Other medications used at the time of event:
None
Other Relevant History, Including Preexisting Medical Conditions:
None

Patient’s Age at the time of event: 57
Patient’s gender: M
Patient’s weight at the timeof event: 210

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