Drug Safety Alert: IPC Flags Blurred Vision Risk with Dacarbazine, Sexual Dysfunction Linked to Dolutegravir
New Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest Drug Safety Alert has flagged safety signals indicating that the anticancer drug Dacarbazine may be associated with transient reversible blurred vision, while the antiretroviral drug Dolutegravir may be linked to sexual dysfunction.
In connection with the above, the 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 drug reactions (ADRs) during therapy.
This follows an analysis of adverse drug reaction (ADR) reports available in the Pharmacovigilance Programme of India (PvPI) database, which identified the above safety concerns.
Dacarbazine is an antineoplastic agent primarily used in chemotherapy regimens for the treatment of malignant melanoma, Hodgkin’s lymphoma, and certain soft tissue sarcomas. It works by damaging cancer cell DNA to stop growth. Common side effects include severe nausea, vomiting, bone marrow suppression, and hair loss. It is administered by qualified medical staff.
The safety alert noted that Dacarbazine is indicated in the chemotherapy of malignant melanoma, Hodgkin’s lymphoma, and soft tissue sarcomas. Based on the preliminary analysis of ADRs from the PvPI database, the drug has been reported to cause transient reversible blurred vision, a condition characterized by temporary impairment of visual clarity that typically resolves upon discontinuation or completion of therapy.
Dolutegravir, on the other hand, is an antiviral agent used for the treatment of HIV-1 infections in combination with other antiretroviral agents.
Dolutegravir is an HIV-1 integrase inhibitor that blocks the strand transfer step of the integration of the viral genome into the host cell (INSTI). The effect of this drug has no homology in human host cells, which gives it excellent tolerability and minimal toxicity. Dolutegravir was developed by ViiV Healthcare and FDA-approved on August 12, 2013.
The alert stated that Dolutegravir is indicated as part of combination antiretroviral therapy for HIV-1 infection. Following review of reports in the PvPI database, the drug has been associated with sexual dysfunction.
As per the issued Drug Safety Alert (File No. P.17019/03/2025-DSA dated February 20, 2026), the suspected drugs and their associated ADRs are as follows:
S. No. | Suspected Drugs | Indication(s) | Adverse Drug Reactions |
1 | Dacarbazine | Chemotherapy of malignant melanoma, Hodgkin’s lymphoma and soft tissue sarcomas. | Transient reversible blurred vision |
2 | Dolutegravir | In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus Type 1 (HIV 1) infection. | Sexual dysfunction |
In light of the above findings, the IPC has urged healthcare professionals and consumers to carefully monitor for these suspected adverse reactions.
The safety alert further stated that any such reactions should be reported to the National Coordination Centre (NCC)-PvPI, IPC, by submitting the Suspected Adverse Drug Reactions Reporting Form for healthcare professionals or the Medicines Side Effect Reporting Form for consumers, available on the official IPC website (www.ipc.gov.in), or through the PvPI Helpline No. 1800-180-3024 (toll-free).
To view the official notice, click the link below:
