login
Become a member
Quick Registration
Full Registration Benefits -
Free Homepages for Doctors
Free Homepages for Hospitals
Free Homepages for Medical Conference
Free Homepages for NGO's
Personal Health Record Creation
Access to all Medical Slides
Access to all Jobs & Products Sale
Investigation into Avandia Raises Concerns About Drug Regulatory System
BMJ Editor in Chief, Dr Fiona Godlee, believes that the drug should not have been licensed and should now be withdrawn. She also calls for more robust regulatory processes and better access to the raw data used to license drugs to allow scrutiny by the scientific community.
The investigation reveals that in July the Commission on Human Medicines advised the MHRA to withdraw the drug as the “risks of rosiglitazone outweigh its benefits and that it no longer has a place on the UK market”.
In light of these concerns, doctors are also advising that no new patients should be started on rosiglitazone, and patients already taking it should be reviewed and alternative treatments considered. Those at higher risk of heart disease should be advised to stop taking the drug.
Rosiglitazone, manufactured by Glaxo SmithKline (GSK) was approved by the US Food and Drug Administration (FDA) in 1999 and by the European Medicines Agency (EMA) in 2000 to help lower blood sugar levels in patients with type 2 diabetes.
Since its approval, several studies have suggested that rosiglitazone may lead to a small overall increase in the risk of heart attacks, but in July an FDA scientific advisory panel recommended that it was safe enough to stay on the market.
In her report, Dr Deborah Cohen investigations editor of the BMJ, obtained documents under the Freedom of Information Act that note a paucity of evidence during the European approval process and outline concerns from some panel members about the long term risks and benefits of rosiglitazone. Other experts have since remarked on the poor evidence base and lack of long term data on cardiovascular safety.
|
|
|
More News on: Drug Toxicity, Signature Drug Toxicity
 Comment & Contribute
|
|
11/06/2010
Chloramphenicol works by preventing bacteria from producing proteins that are essential to them. Without these proteins the bacteria cannot grow, replicate and increase in numbers.
Reply |
Forward
11/06/2010
|
- Health News Index
- News Quick Links
| News Categories: |
| » | Cardio-Pulmonary Function can be a Strong Indicator for Survival Chances of Breast Cancer Patients |
| » | Post Surgery Will the Tumour Return? New Breast Cancer Test to Predict Exactly |
| » | Scientists Develop Compound That Triggers Cancer Cell Death |
| » | Iraqi National Hopes to Find Affordable Treatment for His Cancer in India |
| » | New Technique can Help Doctors Detect Pancreatic Cancer |
| More Cancer News | |
|
