Drug Safety Alert 2026: IPC Flags Blurred Vision Risk With Dacarbazine and Sexual Dysfunction Linked to Dolutegravir
Indian Pharmacopoeia Commission (IPC), in its latest Drug Safety Alert, has flagged safety signals indicating the anticancer drug; Dacarbazine may be associated with transient reversible blurred vision, while antiretroviral drug Dolutegravir may be linked to sexual dysfunction.
Indian Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, has advised healthcare professionals and patients to remain vigilant and closely monitor the occurrence of these suspected adverse reactions during therapy.
Dacarbazine is an anticancer drug, used for the treatments of malignant melanoma, Hodgkin’s lymphoma and certain soft tissue sarcoma. It acts by damaging DNA of cancer cells, in association with some side effects like hair loss, nausea, vomiting and bone marrow suppression.
The safety alert noted, based on the analysis of ADR reports from the Pharmacovigilance Programme of India (PvPI) database, Dacarbazine drug has been reported to cause transient reversible blurred vision, a condition characterised by temporary impairment of vision clarity that typically resolves upon discontinuation of Dacarbazine therapy.
On the other hand, Dolutegravir, in combination with other antiretroviral drugs is used for the treatment of Human Immunodeficiency Virus Type-1 (HIV 1) infection and, It acts by blocking integrase enzyme; thereby stopping the virus from copying its DNA, without affecting host cells (INSTI). It has been seen that Dolutegravir has excellent tolerability with minimal toxicity.
The safety alert noted, based on the analysis of ADR reports from the Pharmacovigilance Programme of India (PvPI) database, Dolutegravir has reported to cause sexual dysfunction.
In light of the above findings, IPC has urged healthcare professional and patients to closely monitor for the suspected adverse reactions associated with Dacarbazine and Dolutegravir therapies.
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