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U.S. Department of Health and Human Services

Drugs

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Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 2009

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 2009 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 from the Adverse Event Reporting System (AERS) between January - March 2009

Product Name: Active Ingredient (Trade)
or Product Class
Potential Signal of a Serious Risk/New Safety InformationAdditional Information
(as of August 1, 2013)
Alpha interferon productsPulmonary HypertensionPulmonary hypertension was added to the Warnings section of the labeling for all alpha interferon products.  See September 2009 FDA announcement: New Class Safety Labeling Updates for Alpha Interferon Products
Ceftriaxone (Rocephin)Hemolytic anemia

Hemolytic anemia was added to the Warnings section of labeling in June 2009.

Ceftriaxone (Rocephin) Label approved June 7, 2009 (PDF - 154KB)

Diclofenac epolamine patch (Flector)Hypersensitivity reactions

The Warnings and Precautions section of the labeling for Flector was updated January 2011, to include anaphylaxis-type hypersensitivity reactions.

Diclofenac epolamine patch (Flector) Labeling approved January 31, 2011 (PDF - 416KB)

Didanosine (Videx)Portal hypertension

FDA Drug Safety Communication

The Warnings and Precautions section of the labeling was updated to include portal hypertension.

Didanosine (Videx) Labeling approved January 25, 2010 (PDF – 306KB)

Entacapone (Comtan)
and
carbidopa/levodopa/entacapone (Stalevo)
Colitis

The Precautions section of the labeling for Comtan and Stalevo was updated October 2010, to include colitis.

Entacapone (Comtan) Labeling approved October 11, 2010 (PDF - 120KB

Carbidopa, levodopa and entacapone (Stalevo) Labeling approved October 11, 2010 (PDF - 204KB)

Gadolinium-based contrast agentsAnaphylaxis

FDA is evaluating this issue to determine if labeling for the various gadolinium-based contrast agents, which include descriptions of hypersensitivity reactions, are adequate.

A Hypersensitivity Reactions subsection was added to the Warnings section of the MultiHance label in October 2009.

Gadobenate dimeglumine (MultiHance) Labeling approved October 2, 2009 (PDF - 967KB)

Mecasermin products (Increlex, Iplex)Hypersensitivity reactions

The Warnings and Precautions, Adverse Reactions, and Contraindications sections of the labeling for Increlex were updated February 2011, to include the risk for hypersensitivity reactions.

Mecasermim (Increlex) Labeling approved February 16, 2011 (PDF - 268KB)

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.

Methylnaltrexone (Relistor)Gastrointestinal perforation

The Warnings and Precautions and Adverse Reactions sections of the labeling for Relistor were updated July 2010, to include the risk for gastrointestinal perforation.

Methylnaltrexone (Relistor) Labeling approved July 23, 2010 (PDF - 454KB)

Minocycline products
(Minocin)
(Solodyn)
Autoimmune disorders in pediatric patients, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

The Warnings and Precautions section of the labeling for Minocin was updated September 2010, to include the risk for DRESS.

Minocycline (Minocin) Labeling approved September 14, 2010 (PDF - 227KB)

The Warnings and Precautions section of the labeling for Solodyn was updated March 2011, to include the risk for DRESS.

Minocycline (Solodyn) Labeling approved March 18, 2011 (PDF - 327KB)

Promethazine injectionSevere tissue injury including gangrene

In September 2009 FDA informed manufacturers of promethazine injection to include a Boxed Warning in the labeling to highlight the risk of serious tissue injury when this drug is administered incorrectly.

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

Sunitinib (Sutent)Liver failure

FDA approved a Medication Guide only Risk Evaluation and Mitigation Strategy (REMS) in July 2010.

Sunitinib (Sutent) Medication Guide approved July 1, 2010 (PDF - 167KB)

Sunitinib (Sutent) Labeling approved July 1, 2010 (PDF - 213KB)

Tenofovir (Viread)Safety during pregnancyFDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.
Zoledronic acid (Reclast)Renal impairment

Renal impairment was added to the Warnings and Precautions section of labeling in March 2009.

Zoledronic acid (Reclast) Labeling approved March 13, 2009 (PDF - 258KB)