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U.S. Department of Health and Human Services

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Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2010

 

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 April - June 2010 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) April - June 2010

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of August 1, 2013)

Clindamycin injection (Cleocin)

Overdose due to labeling confusion/medication errors

The presentation of strength and concentration on the carton and container labeling for Cleocin was updated October 2010.

Doxycycline products

Stevens Johnson Syndrome,
Toxic Epidermal Necrolysis,
Erythema Multiforme

The Adverse Reactions section of the labeling for Doryx was updated March 2011, to include Stevens Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.

Doxycycline hyclate delayed-release tablet (Doryx) Labeling approved March 21, 2011 (PDF - 131KB)

The Adverse Reactions section of the labeling for Vibramycin was updated May 2011, to include Stevens Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.

Doxycycline (Vibramycin) Labeling approved May 11, 2011 (PDF - 94KB)

The Adverse Reactions section of the labeling for Monodox was updated March 2011, to include Stevens Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.


Doxycycline (Monodox) Labeling approved March 8, 2011 (PDF - 124KB) 

Dronedarone hydrochloride
(Multaq)

Torsade de Pointes

FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

Etonogestrel implant (Implanon, Nexplanon)

Convulsions

The Adverse Reactions section of the labeling for Implanon was updated February 2012, to include convulsions.

Etonogestrel implant (Implanon) Labeling approved February 1, 2012 (PDF - 665KB)

The Adverse Reactions section of the labeling for Nexplanon was updated May 2011, to include convulsions.

Etonogestrel implant (Nexplanon) Labeling approved May 13, 2011 (PDF - 528KB)

Everolimus
(Afinitor)

Hepatitis B reactivation

The Warnings and Precautions section of the labeling for Afinitor was updated July 2010, to include Hepatitis B reactivation.
Everolimus (Afinitor) Labeling approved July 9, 2010 (PDF - 1.08MB)

Febuxostat
(Uloric)

Hypersensitivity

The Adverse Reactions section of the labeling for Uloric was updated January 2011, to include hypersensitivity. FDA is continuing to monitor this issue to determine the need for any further regulatory action.

Febuxostat (Uloric) Labeling approved January 28, 2011 (PDF - 131KB)

Ferumoxytol injection (Feraheme)

Serious cardiac disorders

The Adverse Reactions section of the labeling for Feraheme was updated November 2010, to include serious cardiac disorders.

Ferumoxytol injection (Feraheme) Labeling approved November 24, 2010 (PDF - 99KB)

GnRH Agonists
(Androgen Deprivation Therapy)

Hyperinsulinemia, Arterial thrombosis

The Warnings and Precautions section of the labeling of all of the GnRH Agonists has been updated to add hyperinsulinemia and arterial thrombosis.

Refer to the January 2011 Safety Labeling Changes summary page on the MedWatch Web site.

An update was issued by FDA on October 20, 2010 to the FDA Drug Safety Communication issued in May 2010.

FDA Drug Safety Communication

Lanthanum carbonate (Fosrenol)

Intestinal obstruction

The Warnings and Precautions, Adverse Reactions, and Contraindications sections of the labeling for Fosrenol were updated March 2011, to include intestinal obstruction.

Lanthanum carbonate (Fosrenol) labeling approved April 27, 2011 (PDF - 89KB)

Proton Pump Inhibitors (PPIs)

Hypomagnesemia

FDA Drug Safety Communication

The Warnings and Precautions section of the labeling of all of the proton pump inhibitors has been updated to include hypomagnesemia.

Refer to the June 2011 Safety Labeling Changes summary page on the MedWatch Web site.

Saquinavir mesylate (Invirase)

Prolonged QT and PR Syndromes

An update was issued by FDA on October 21, 2010 to the FDA Drug Safety Communication issued in February 2010.

FDA Drug Safety Communication

The Warnings and Precautions section of the labeling for Invirase was updated October 2010, to include QT and PR interval prolongation.

Saquinavir mesylate (Invirase) Labeling approved October 6, 2010 (PDF - 591KB)

Simvastatin
(Zocor)

Muscle injury with 80mg dose

FDA Drug Safety Communication

FDA Patient Safety News, June 2010

The Dosage and Administration, Contraindications, and Warnings and Precautions sections of the labeling for Zocor were updated June 2011, to include information about muscle injury with the 80 mg dose.

Simvastatin (Zocor) Labeling approved June 8, 2011 (PDF - 362KB)

Tapentadol hydrochloride (Nucynta)

Convulsions, Hallucinations, Serotonin syndrome

The Adverse Reactions section of the labeling for Nucynta was updated January 2011, to include hallucinations. 

FDA is continuing to evaluate these issues to determine the need for any further regulatory action.

Trastuzumab
(Herceptin)

Neonatal pulmonary hypoplasia

A Black Box Warning for Embryo-Fetal Toxicity was added to the labeling for Herceptin October 2010, including updates to the Warnings and Precautions, and Use in Specific Populations sections of the labeling, for this issue.

Trastuzumab (Herceptin) Labeling approved October 29, 2010 (PDF - 688KB)