Just because you report a side effect or an adverse reaction, doesn’t mean the regulators actually give a damn..

There are many drugs which have caused life threatening reactions in recent years and they remain on the market…

Avandia, Paxil, Zyprexa to name but a few…

It is not in the regulators interest to pull drugs even if they are killers…
They stall for as long as they can and even then the drugs are rarely pulled…

My intentions were good but I don’t think I can get back to you today. Apologies. I won’t forget to post what I find.

It sounds like you’re saying that the simpler the problem the less time it takes for an alert to be sent out. Makes sense. It’s easier.

Alternately, a larger problem, based on the time required for possible additional testing and investigation, leaves no alert for a longer period of time, while the public continues to suffer ill effects. That seems more than a little worrysome and backwards.

When any danger is reported you would think some pretty rapid reaction would come about. After all, if the FDA (and whatever pharmaceutical company is involved) is not going to respond quickly to adverse post-marketing reports, then post-marketing studies seem nothing more than marketing at the cost of the public’s well-being.

I’m just trying to understand and I do thank you for trying to find the answer.

I’ll see if I can get a time estimate for you. If it’s a slight labeling change I imagine it doesn’t take that long. (That’s the form the majority of Alerts take.) Following entry of your MedWatch report into the data base, a case series analysis is usually performed. They aren’t really that useful in establishing causality but may give hypotheses that can be explored in epidemiology studies (clinical studies, patient registries, prospective cohort studies). Clincal studies, as you know, require time and involvement of the manufacturer. Cohort studies from third-party data bases are easier to do, all things considered.

I realize I’m not answering your question adequately but the specific nature of the serious adverse event and its association with the drug will drive what the FDA requires and its time frame. Drugs associated with death and permanent disability will likely cause the FDA to move much faster.

Regardless, I’ll get back to you tomorrow with what I can find.

I’d be cool with that. How long do you suppose it takes to put out a notice?

to Just a Thought–you’re not going to get any feedback. Alterts, when they are issued, are posted on the FDA MedWatch web site, communicated electronically to health care providers who have signed up for e-Alerts, and to Partners (mostly health care provider associations) and to health and medical media.

In my experience, the words May and Might mean ‘not gonna happen’.

Thanks for the automated form letter though, I feel all better now.

(one… two… shoot, I lost count. one… two…)

~~~~~~~~~~~~~~~~~~~~~~~~

Dear Reporter:

Thank you for submitting your report to MedWatch, The FDA Safety Information and Adverse Event Reporting Program.

This acknowledgement confirms that your report was received. Reports are added to a postmarketing safety database with similar reports and reviewed by the FDA’s postmarketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day.

You might be contacted by an FDA staff member if additional information on your report
is needed.

Again, thank you for taking the time to submit your report.

Sincerely yours,

MedWatch

In the past, they’ve made much the same kind of points that you do here to explain why a number of these studies don’t happen.