Building consensus on off-label uses of sildenafil

We are building consensus on the off-label uses of sildenafil. The current indications approved by DCGI are as follows:

Drug Name	Indication	Date of Approval
Sildenafil citrate film coated 25/50/100 mg	By urologist, psychiatrist, endocrinologist in erectile dysfunction in men.	08/01/2001	Cardiologists decide about contraindications but cannot prescribe.
Sildenafil Citrate Orally Disintegrating Strips: 25mg / 50mg	Erectile dysfunction.	05.07.13	Quick acting. Does not mention about restrictions of prescribers. 100 mg will be off label use.
Sildenafil Citrate 20mg	Pulmonary arterial hypertension (WHO group I) to improve exercise ability.	23.01.07	Approved only for primary PPH. For others it will be off label use. Does not mention about prescribing restrictions.
Sildenafil Citrate Injection 0.8mg/ml	Pulmonary arterial hypertension (PAH) (WHO Group-1) to improve exercise ability and delay clinical worsening.	05.12.12

 (Source: New Drugs Approved by CDSCO at https://cdscoonline.gov.in/CDSCO/Drugs)

Sildenafil can be prescribed by all. This discrepancy in indications should be taken out.

The responses received so far for off label use of tadalafil are as below:

·                     Dr Pai: Insert in the vagina before or after embryo transfer and continue it for 15 days till pregnancy test is done, to find out whether patient is pregnant. Sildenafil is used in patients with poor endometrial growth or with recurrent IVF failures.

·                     Dr Prashant Tanna: Newborn in persistent pulmonary hypertension

·                     Dr Gian Chand Rana: Only by MBBS

·                     Viraj Suvarna: Sildenafil with nintedanib versus nintedanib alone is currently being examined in severe idiopathic pulmonary fibrosis. Earlier study where sildenafil was tried in such patients and while it did not improve the 6-minute walk test (primary endpoint), it did improve certain QOL measures (secondary endpoints) - the STEP trial.

o    Women with clitoral erectile dysfunction.

o    Hypoactive sexual desire disorder

o    All types of pulmonary hypertension (like tadalafil is approved)

Drug Name	Indication	Date of Approval
Tadalafil Tablet2.5mg/5mg	1. Erectile dysfunction. 2. Erectile dysfunction with benign prostatic hyperplasia	27.02.13
Tadalafil tablet 20 mg(Additional Indication)	Pulmonary arterial hypertension	14.11.09
Tadalafil Orally Disintegrating Strip10mg & 20mg (Additional dosage form)	Erectile dysfunction	30.07.14
Tadalafil 10mg/20mgTablets	Erectile dysfunction in adult men	11/09/2003

 (Source: New Drugs Approved by CDSCO at https://cdscoonline.gov.in/CDSCO/Drugs)

Off label use of tadalafil

·     Benign prostatic hyperplasia (BPH) without erectile dysfunction

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA