US FDA finds potential signs of AERs in drugs including cancer and bowel agents

The US Food and Drug Administration has issued a list of pharmaceutical compounds which it believes may pose a serious risks/new safety, identified 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 the 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.

According to the list, the US regulator is reviewing cases of liver failure in patients treated with Pfizer's kidney cancer drug Sutent (sunitinib), as well as gastrointestinal perforation among users of Wyeth and Progenics' Relistor (methylnaltrexone), which is approved as a treatment for opioid-induced constipation.

However, the FDA stresses that the listing of a drug and a potential safety issue does not mean that the agency is suggesting non-prescribing or consumption of the products but rather that 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

Ceftriaxone (Rocephin) Hemolytic anemia Hemolytic anemia was added to the Warnings section of labeling in June 2009.
Ceftriaxone (Rocephin)

Diclofenac epolamine patch (Flector) Hypersensitivity reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Didanosine (Videx) Portal hypertension FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Entacapone (Comtan) Colitis FDA is continuing to evaluate this issue to determine the need for any regulatory action.

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

Alpha interferon products Pulmonary Hypertension Pulmonary hypertension was added to the Warnings section of labeling for all alpha interferon products.  See September 2009 FDA announcement: New Class Safety Labeling Updates for Alpha Interferon Products

Mecasermin products (Increlex, Iplex) Hypersensitivity reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Methylnaltrexone (Relistor) Gastrointestinal perforation FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Minocycline (Solodyn) Autoimmune disorders in pediatric patients FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Promethazine injection Severe 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