FDA Looking at Pfizer’s Sutent, Others for Possible Side Effects

The cancer drug Sutent and a dozen other medications are undergoing closer scrutiny by the Food and Drug Administration for possible risks of serious side effects, the agency said today.

The FDA just released a list of drugs it is further investigating after reports of side effects were received through the agency’s Adverse Event Reporting System between January and March 2009.

Appearing on the list “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,” the agency said.

Sutent on List of Potentially Dangerous Drugs

Sutent, the Pfizer Inc. drug known chemically as sunitinib, is the best-known drug on the FDA watch list. The agency reportedly is investigating reports of liver failure in Sutent patients.

In July, a late-stage clinical trial of the drug was halted early after researchers determined the drug was no better at fighting advanced colon cancer than standard chemotherapy.

The FDA also is investigating reports on the Wyeth and Progenics Pharmaceuticals bowel medication Relistor (known chemically as methylnaltrexone), which may be linked to gastrointestinal perforations.

The other drugs on the FDA warning list, their brand names, and their possible side effects include:

• Ceftriaxone (Rochephin) for hemolytic anemia

• Diclofenac epolamine patch (Flector) for hypersensitivity reactions

• Didanosine (Videx) for portal hypertension

• Entacapone (Comtan) for colitis

• Gadolinium-based contrast agents for anaphylaxis

• Alpha interferon products for pulmonary hypertension

• Mecasermin products (Increlex and Iplex) for hypersensitivity reactions

• Minocycline (Solodyn) for autoimmune disorders in pediatric patients

• Promethazine injection for severe tissue injury, including gangrene

• Tenofovir (Viread) to determine safety of use during pregnancy

• Zoledronic acid (Reclast) for renal impairment

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