Accessing adverse effects reporting data

General Discussion Media & Awareness
#1

Hi guys

Apologies if this information is elsewhere on this site. The number of potential side effects listed by Merck is woefully small, considering the side effects reported on this site alone. How many reports of a side effect does it take to the FDA etc before they are legally obliged to include this information on their leaflets? Compared to other medications I’ve taken where the potential adverse reactions section is quite comprehensive, breaking down statistically from >1 in ten etc., Merck appears to be providing as little info as they can get away with, possibly as listing some of the real side effects would be so damaging to sales. Considering so many guys have reported penile shrinkage it seems at best negligent and at worst criminal that Merck isn’t compelled to include all adverse reactions in their literature.

As my subject header states, is their any way of accessing submitted reports data from the FDA website? I can access the UK equivalent.

#2

Merck does not care. The FDA does not care, but they will make it appear as if they do simply to cover their own interest. I may be wrong, but I do not believe we can get access to other peoples reports because of the issue of privacy.

#3

FDA stats are here but you need to setup a relational database via MS Access etc to read them.

fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm

#4

Mew, is this complicated? Is it something one person can do and post the info to the site in excel format?

#5

Out of curiosity - has anybody analyzed this data? The recent FDA press release analyzed through 4Q2011 and some of the recent reports may be more illuminating.