NeLM news service
FDA releases quarterly list of early investigations into potential adverse drug reactions identified between January and March 2009

Source: FDA, Reuters Health

Date published: 09/10/2009 17:08

Summary
by: Yuet Wan

The FDA has published its quarterly list of safety probes, which forms part of the effort to inform the public about early investigations into potential adverse drug reactions that have been reported. The current list covers issues identified between January and March 2009 as follows:

 

1. Ceftriaxone (Rocephin®): Hemolytic anaemia
2. Diclofenac epolamine patch (Flector®): Hypersensitivity reactions

3. Didanosine (Videx®): Portal hypertension

4. Entacapone (Comtan): Colitis

5. Gadolinium-based contrast agents: Anaphylaxis

6. Alpha interferon products: Pulmonary Hypertension

7. Mecasermin products (Increlex®, Iplex®): Hypersensitivity reactions

8. Methylnaltrexone (Relistor®): Gastrointestinal perforation

9. Minocycline (Solodyn®): Autoimmune disorders in paediatric patients

10. Promethazine injection: Severe tissue injury including gangrene

11. Sunitinib (Sutent®): Liver failure

12. Tenofovir (Viread®): Safety during pregnancy

13. Zoledronic acid (Reclast®): Renal impairment

 

The appearance of a drug on this list does not mean that the FDA has identified a causal relationship between the drug and the listed risk, only that it has identified a potential safety issue. 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 labelling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterise the risk.

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Related news
1.2 Antispasmodics and other drugs altering gut motility
3.4.1 Antihistamines
5.1.2 Cephalosporins, carbapenems, and other beta-lactams
5.1.3 Tetracyclines
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10.1.1 Non-steroidal anti-inflammatory drugs