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New Delhi , Dec. 8

SUN Pharmaceuticals and Dabur (India) Ltd have been issued "serious warnings" by the Government to refrain from promoting off-label use of oral anti-cancer drug, Letrozole, for the treatment of infertility.

The Union Health Minister, Ms Sushma Swaraj, told the Rajya Sabha on Monday after examining the clarification given by the firms and the published literature on Letrozole that both companies have been asked to refrain from any such promotional activity which may induce off-label use of Letrozole to treat infertility "and to destroy all relevant promotional material claiming its use in unapproved indications".

An advisory that Letrozole has not been approved as treatment for infertility has been issued to States," she said.

The Government had approved Letrozole from Sun Pharma on June 28, 2001 as a second line of treatment of advanced breast cancer in women.

"Since no formal approval was issued for the use of Letrozole as a fertility drug, the firm was issued a notice on September 25, 2003 to explain their alleged promotion of the drug as a fertility drug. Dabur was also asked to explain the alleged promotion of the drug for fertility enhancement," Ms Swaraj said.

Both Dabur and Sun Pharma were not making any claims about Letrozole's use in fertility on product labels; however, gynaecologists who asked for details were provided relevant information, the Minister added.

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