[e-drug] Request for information about tamsulosin

e-drug
1

E-DRUG: Request for information about tamsulosin
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Dear E-drug,
I recently subscribed to this list, I want to ask the following question
to any person which could provide me with valuable information.

I am doing a research about alpha blockers approved for benign prostatic
hyperplasia (i.e., tamsulosin, alfuzosin, and silodosin) related to
adverse drug reactions, published and unpublished studies.

I want to know if any person subscribed to this list have information
about unpublished studies and adverse drug reactions such as severe
hypotension, cardiovascular disease and floppy iris. Case reports
(published or unpublished) and papers are very valuable. In addition,
information about databases and opinions are also very helpful.

Floppy iris is an adverse drug reaction associated with alpha blockers,
this reaction was described in the period of post marketing
surveillance. In November 2013, the research group of Bird and
Colleagues published a study associating severe hypotension with
tamsulosin. Recently, a physician in the UK told me about a case of
sudden cardiac death, an alpha blocker was the only drug prescribed to
this patient. Reports about alpha blockers and mental disturbances have
also been recently described in a Brazilian Journal.

There is a high number of unpublished observational and randomized
clinical trials with uroselective alpha blockers:
  tamsulosin, silodosin, and alfuzosin. For example, there are 34
clinicaltrials.gov <http://clinicaltrials.gov> registries with
completion dates before January 2010, only seven of these registries
have published results in scientific journals.

Only four of the unpublished studies have results available in clinicaltrials.gov
<http://clinicaltrials.gov>. Data of 23 studies (n=6647 patients) about
tamsulosin remains unknown.

I appreciate any information regarding this pharmacological group.

Best wishes,

Jorge H. Ramírez
Professor at Universidad del Valle, Cali, Colombia.
Jorge Ramirez <jorge.h.ramirez00@gmail.com>

2

E-DRUG: Request for information about tamsulosin (2)
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Dear Jorge,

Unpublished clinical trials and analyses for drugs approved in the US are
available on the FDA's Drugs@FDA Web site at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

Additionally, unpublished studies and analyses for drug's with safety
problems or refused approval in the US are available at
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm

If you have access to the Iowa Drug Information Service from the University
of Iowa College of Pharmacy these FDA documents are indexed.

Best regards,

Larry

Larry D. Sasich, PharmD, MPH, FASHP
1201 North Shore Blvd East #803
Burlington, Ontario L7S 1Z5
Canada
Cell: 705-491-0609
E-Mail: larry.sasich@gmail.com