PMID- 22023666
OWN - NLM
STAT- MEDLINE
DCOM- 20120507
LR  - 20151119
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 9
IP  - 1
DP  - 2012 Jan
TI  - 10-Year analysis of adverse event reports to the Food and Drug Administration for 
      phosphodiesterase type-5 inhibitors.
PG  - 265-70
LID - 10.1111/j.1743-6109.2011.02537.x [doi]
AB  - INTRODUCTION: To ensure public safety all Food and Drug Administration 
      (FDA)-approved medications undergo postapproval safety analysis. 
      Phosphodiesterase type-5 inhibitors (PDE5-i) are generally regarded as safe and 
      effective. AIM: We performed a nonindustry-sponsored analysis of FDA reports for 
      sildenafil, tadalafil, and vardenafil to evaluate the reported cardiovascular and 
      mortality events over the past 10 years. METHODS: Summarized reports of adverse 
      events (AEs) for each PDE5-i were requested from the Center for Drug Evaluation 
      and Research within the FDA. These data are available under the Freedom of 
      Information Act and document industry and nonindustry reports of AEs entered into 
      the computerized system maintained by the Office of Surveillance and 
      Epidemiology. MAIN OUTCOME MEASURE: The data were analyzed for the number of AE 
      reports, number of objective cardiovascular events, and reported deaths. RESULTS: 
      Overall, 14,818 AEs were reported for sildenafil. There were 1,824 (12.3%) 
      reported deaths, and reports of cardiovascular AEs numbered 2,406 (16.2%). 
      Tadalafil was associated with 5,548 AEs and 236 deaths were reported. Vardenafil 
      was associated with 6,085 AEs and 121 reports of deaths. The percentage of 
      reported severe cardiovascular disorders has stabilized at 10% to 15% of all AE 
      reports for sildenafil and tadalafil and 5% to 10% for vardenafil. Only 10% of AE 
      reports sent to the FDA for PDE5-i were from pharmaceutical manufacturers. 
      CONCLUSION: Reports of deaths associated with PDE5-i remain around 5% of total 
      reported events. Despite inherent limitations from evaluating FDA reports of AEs, 
      it is important that these reports be reviewed outside pharmaceutical industry 
      support in order to provide due diligence and transparency. Lowe G and Costabile 
      RA. 10-year analysis of adverse event reports to the Food and Drug Administration 
      for phosphodiesterase type-5 inhibitors. J Sex Med 2012;9:265-270.
CI  - (c) 2011 International Society for Sexual Medicine.
FAU - Lowe, Gregory
AU  - Lowe G
AD  - Department of Urology, Ohio State University Medical Center, Columbus, OH 43210, 
      USA. gregory.lowe@osumc.edu
FAU - Costabile, Raymond A
AU  - Costabile RA
LA  - eng
PT  - Journal Article
DEP - 20111024
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Carbolines)
RN  - 0 (Imidazoles)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 0 (Piperazines)
RN  - 0 (Purines)
RN  - 0 (Sulfones)
RN  - 0 (Triazines)
RN  - 5O8R96XMH7 (Vardenafil Dihydrochloride)
RN  - 742SXX0ICT (Tadalafil)
RN  - BW9B0ZE037 (Sildenafil Citrate)
SB  - IM
MH  - Carbolines/adverse effects/therapeutic use
MH  - Cardiovascular Diseases/chemically induced
MH  - Erectile Dysfunction/drug therapy
MH  - Humans
MH  - Imidazoles/adverse effects/therapeutic use
MH  - Male
MH  - Phosphodiesterase 5 Inhibitors/*adverse effects/therapeutic use
MH  - Piperazines/adverse effects/therapeutic use
MH  - Product Surveillance, Postmarketing/statistics & numerical data
MH  - Purines/adverse effects/therapeutic use
MH  - Sildenafil Citrate
MH  - Sulfones/adverse effects/therapeutic use
MH  - Tadalafil
MH  - Triazines/adverse effects/therapeutic use
MH  - United States
MH  - United States Food and Drug Administration/statistics & numerical data
MH  - Vardenafil Dihydrochloride
EDAT- 2011/10/26 06:00
MHDA- 2012/05/09 06:00
CRDT- 2011/10/26 06:00
PHST- 2011/10/26 06:00 [entrez]
PHST- 2011/10/26 06:00 [pubmed]
PHST- 2012/05/09 06:00 [medline]
AID - S1743-6095(15)33736-X [pii]
AID - 10.1111/j.1743-6109.2011.02537.x [doi]
PST - ppublish
SO  - J Sex Med. 2012 Jan;9(1):265-70. doi: 10.1111/j.1743-6109.2011.02537.x. Epub 2011 
      Oct 24.