Drug Safety List Released

The FDA has released a list of drugs that are being monitored by the federal agency for possible safety issues. The list is compiled from the Adverse Event Reporting System and names those drugs who made the adverse event list after a safety issue was raised with the particular drug. The list is published quarterly and includes drugs such as:
Ceftriaxone (Rocephin) – Hemolytic anemia was added to the Warnings section of labeling in June 2009
Diclofenac epolamine patch (Flector) – Hypersensitivity reactions
Didanosine (Videx) – Portal hypertension
Entacapone (Comtan) – Colitis
Gadolinium-based contrast agents – Anaphylaxis
Alpha interferon products – Pulmonary Hypertension
Mecasermin products (Increlex, Iplex) – Hypersensitivity reactions
Methylnaltrexone (Relistor) – Gastrointestinal perforation
Minocycline (Solodyn) – Autoimmune disorders in pediatric patients
Promethazine injection – 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.
Sunitinib (Sutent) – Liver failure
Tenofovir (Viread) – Safety during pregnancy
Zoledronic acid (Reclast) – Renal impairment was added to the Warnings and Precautions section of labeling in March 2009.
Other than making the list and being monitored by the FDA, no further information is provided. The FDA is careful to point out that a drug’s listing does not necessarily mean there are safety issues with the drug or that doctors should not prescribe the drug.