At least I have a job...
This is the reason why:
- I've worked insane hours since November
- Missed N's family's Christmas shindig (although to be honest, I wasn't too upset about that)
- Left work last night at 7pm
- Arrived back at 4am this morning.
To save you clicking on the link, the short version is: FDA are continuing to review one of the products that I look after -- Meridia, which is used to treat obesity. We did a clinical study as a postapproval commitment to the European agencies, and the results of the study suggest that patients taking Meridia might have an increased risk of heart attacks and strokes compared to the patients who took placebo. FDA have determined that our product information needs to be changed to state that patients with a history of heart disease should not take the drug. They also state that after we submit all the data for their review they will put together a public advisory committee hearing to discuss the drug, and it's risk/benefit profile, and determine if any further actions should be taken.
In parallel, the European Medicines Agency today suspended our product approvals for the same product (called Reductil in Europe). That means we can no longer promote, sell or allow prescriptions of Reductil in the European Union.
So, all in all, not the best day at work.
But, tomorrow is another day with another set of challenges. At least tomorrow is Friday!
- I've worked insane hours since November
- Missed N's family's Christmas shindig (although to be honest, I wasn't too upset about that)
- Left work last night at 7pm
- Arrived back at 4am this morning.
To save you clicking on the link, the short version is: FDA are continuing to review one of the products that I look after -- Meridia, which is used to treat obesity. We did a clinical study as a postapproval commitment to the European agencies, and the results of the study suggest that patients taking Meridia might have an increased risk of heart attacks and strokes compared to the patients who took placebo. FDA have determined that our product information needs to be changed to state that patients with a history of heart disease should not take the drug. They also state that after we submit all the data for their review they will put together a public advisory committee hearing to discuss the drug, and it's risk/benefit profile, and determine if any further actions should be taken.
In parallel, the European Medicines Agency today suspended our product approvals for the same product (called Reductil in Europe). That means we can no longer promote, sell or allow prescriptions of Reductil in the European Union.
So, all in all, not the best day at work.
But, tomorrow is another day with another set of challenges. At least tomorrow is Friday!