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Drug Safety Alert June 2016

Drug Safety Alert


The preliminary analysis of SUSARs from the PvPI database reveals that the following drugs are associated with the risks as given below.



Suspected Drug


Adverse Reaction(s)



Neovascular Age-Related Macular Degeneration (AMD), Visual impairment due to Diabetic Macular Edema (DME), visual impairment due to Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM).


Myocardial Infarction


Amphotericin B

Life threatening fungal infections including histoplasmosis, coccidioidomycosis, paracoccidioidomycosis, blastomycosis, aspergillosis, cryptaococcosis, mucormycosis, sporotrichosis and candidiasis; visceral and mucocutaneous leishmaniasis unresponsive to pentavalent antimony compounds; severe meningitis. perioral candidiasis.

Bone Marrow Depression



Soft tissue and bone sarcomas, acute leukemia, malignant lymphoma, Hodgkin’s diseases, breast carcinoma, small cell carcinoma of lungs, AIDS-related Kaposi’s sarcoma, multiple myeloma. Gastrointestinal tract carcinoma, bladder cancer, ovarian carcinoma, acute myeloblastic leukemia, thyroid carcinoma, neuroblastoma.

Photosensitivity Reaction



Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that is Anaplastic Lymphoma Kinase (ALK) – positive.

Pneumonitis, Hepatic Encephalopathy


Healthcare professionals, Patients/Consumers are advised to closely monitor the possibility of the above adverse reaction(s) while prescribing/consuming above suspected drugs and report to the NCC-PvPI either by filling of Suspected Adverse Drug Reactions Reporting Form/
Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in) or by PvPI Helpline No. 1800-180-3024.