2005P-0423 Immediately add a black box warning regarding the risks of drug-induced blindness for the three phosphodiesterase 5 inhibitors that are prescribed for the treatment of erectile dysfuntion
FDA Comment Number : EC3
Submitter : Ms. Irene Ferraiuolo Date & Time: 12/19/2005 02:12:39
Organization : Ms. Irene Ferraiuolo
Category : Individual Consumer
Issue Areas/Comments
It is the job and responsibility of manufacturers, doctors, pharmacists, etc to advise consumers of ALL risks regarding drugs or supplementations. Not only should there be a black box warning, but also a verbal warning to the patient by the doctor on the risks involved. The consumer should be made aware of these warning before the purchase of these medications, as drugs are not returnable for a refund after purchase. Also the risks should include possible allergic reactions if the drug/s contain any ingredients considered to individuals as being a high risk allergen.