FDA APPROVAL OF CIALIS IN BPHFDA APPROVAL OF CIALIS IN BPH:FDA has recently approved low dose Cialis for BPH tretment.
NOTE: There is a CATCH to this.
The following perceptions are false:
1. FDA approved drugs are without serious side effects.
2. FDA only approves very effective drugs.
FDA approval only implies that the benefits of the approved agent are judged to be greater than the harms.
- FDA approval is not necessarily based on direct comparisons of effectiveness and safety between the approved drug and the pre-existing standard drug.
- The study for which approval has been based on MAY have compared the approved drug with a placebo. Hence, the FDA approval DOES NOT MEAN that Cialis is better than the alpha blockers or the 5-ARIs (unless it has been compared to another drug or drug in a “head-to-head” clinical trial). It only states that drug's health benefits outweigh its known risks, and hence the drug is approved for sale. And we all know how effective the 5-ARIs are for BPH.
I have not read the studies for which FDA approved Cialis for BPH, and hence will reserve my further comments.
Shared is the link to a recent article in Archives of Int Medicine of the public perception of FDA approval, and what it should actually mean.
Rgds
Rajeen
Source:
FDA APPROVAL OF CIALIS IN BPH
