SSRi's - Changes to the Labeling

Former GSK employee Jane Nieman

I've just re-watched the Jane Nieman deposition that I uploaded to YouTube a couple of years ago.

It's a fascinating insight into how causality assessments come about...or not as was the case with GlaxoSmithKline regarding birth defects and their product Paxil.

The audio is out of sync with the video but it still makes fascinating viewing.

Something toward the end of the video grabbed my attention.

There's one question put to Nieman by the claimants lawyer.

At 48.27 he asks Nieman, Do you know what a manufacturers duty is under the FDA when they make a determination that a drug is responsible for an adverse event, what their labeling duties are?

Nieman does not answer.

Lawyer then says "I can show it to you if you like", he then reads the following to her:

"Under the section heading the label shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them and steps that should be taken if they occur. The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with the drug, a causal relationship need not have been proved."

This particular blog post of mine is more of a reach out to consumers of pharmaceutical prescription products.

Has anyone ever reported a serious adverse event to a pharmaceutical company and had a causality assessment returned that linked the product to the adverse event, if so, was the labeling changed as a direct result of that causality assessment?

I know one case where a pharmaceutical company [Mylan] have not made any effort to change the labeling despite the assessment that their product was the probable cause of death. Do these rules, mentioned in the video, just apply to the FDA, what about other global medicine regulators?

Be great if I could get some feedback on this either via email or my Facebook page.

Meantime, here's the video in question. I recommend watching it all but if you just want to skip to the labeling question then drag the cursor on the video to around the 48.27 mark.

Bob Fiddaman