The FDA has released a list of drugs the agency is reviewing drugs for possible safety issues. Some of the drugs have been noted for safety issues previously, resulting in forced label changes.
The list includes: the cancer drug Sutent; gandolinium-based contrast agents used in MRIs; and Reclast, which is used treat post-menopausal osteoporosis. The full list is:
- 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.
For the FDA safety review list, and more information: http://z-9.us/FDAwatchlist-10-09
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.
Tags: fda, prescription-drugs, safety alerts
