PvPI-Pharmacovigilance Programme for India is a national drug safety monitoring center for India maintained by Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. As part of routine analysis of individual case safety reports (reports of adverse drug event/reactions from a patient) originated from India, PvPI has identified and released two new drug safety alerts for the month of July-2020 to alert the health care professionals to monitor for adverse drug reactions for a better patient safety and public health. The two drug safety alerts were described in brief here below-
Drug Safety Alert-1: Genital Pruritus risk associated with SGLT-2 Inhibitors
Drug Safety Alert-1: Genital Pruritus risk associated with SGLT-2 Inhibitors
Sodium-glucose co-transporter-2 (SGLT-2) Inhibitors are the oral medications which are used in the treatment of type-2 diabetes mellitus. The drugs of this therapeutic class help in improving glycemic control in adults. SGLT-2 is a transporter protein located in the nephrons (cells of kidney) responsible for glucose re-absorption in the kidney. Inhibiting these SGLT-2 receptors blocks the process of glucose re-uptake from urine into the body, thereby increasing the excretion of glucose through urine and finally the decreased level of glucose in the blood. Some of the examples of medications (drugs for diabetes mellitus type 2) falling under this category are Forxiga (Dapagliflozin), vokana (Canagliflozin), Jardiance (Empagliflozin) etc.,
ICSRs from Indian Patients:
NCC-PvPI, National Coordination committee for Pharmacovigilance activities in India receives ICSRs (Individual case safety reports) for the adverse drug events/reactions experienced by patients in India. In the process of preliminary analysis of the safety data, PvPI has identified a significant drug therapeutic class-adverse drug reaction combination: SGLT-2 Inhibitors-Genital Pruritus from the pool of ICSRs.
Pharmacological link with Genital Pruritus risk
The pharmacological action of SGLT2 inhibitors is to produce renal glucosuria by induced urinary glucose concentration and excretion. This is a favorable condition for pathogens to thrive and this could result in genital infections.
Drug Safety communication from US-FDA:
On 07-Sep-2018, United States-Food & Drug Administration (US-FDA) has issued a drug safety communication on the rare occurrences of a serious infection of the genital area with SGLT2 inhibitor class of medications used for diabetes. FDA advised patients to be cautious and monitor for symptoms of this adverse experience such as tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and having a fever above 100.4 F or a general feeling of being unwell. FDA advised health care professionals to assess the symptoms and start the broad-spectrum antibiotics upon onset of signs and symptoms of infection and monitoring blood glucose levels and discontinuation of SGLT2 inhibitor therapy if required provided with alternative treatment for glucose control.
Drug Safety Alert-2: Symmetrical Drug Related Intertriginous and Flexural Exanthema (SDRIFE) associated with Fluconazole use
SDRIFE is a serious cutaneous adverse drug reaction which is also known as baboon syndrome. This reaction involves symmetrical erythematous rashes on the gluteal and intertriginous areas (flexures of body) after systemic exposure to a drug. Typically, the rashes appear at buttocks region resembling the color of a baboon’s buttocks (hence the name-baboon syndrome). This reaction is distinct from other cutaneous adverse drug reactions due to its typical morphology, distribution, and the absence of systemic findings. This serious adverse drug reaction is not very common and there were only few case reports reported pertaining to this safety concern.
Drugs with potential to cause baboon syndrome:
There are some published case reports of baboon syndrome induced by systemic exposure to certain drugs. Some of the commonly used drugs included- omeprazole, hydroxyzine, clozapine, celecoxib, intravenous human immunoglobulins and chemotherapeutic agents like 5-fluorouracil.
Fluconazole associated SDRIFE from Indian Patients:
NCC-PvPI, National Coordination committee for Pharmacovigilance activities in India identified significant case reports containing fluconazole as the suspected drug for the safety concern- Symmetrical Drug Related Intertriginous and Flexural Exanthema (SDRIFE) during their preliminary analysis of the individual case safety reports from Indian patients.
PvPI categorized this drug-ADR combination as a new drug safety alert to sensitize health care professionals across the nation to monitor for this adverse drug reaction while prescribing and administering the fluconazole to patients.
Voluntary ADR reporting
Every medicine present in market-both the prescription medicines from physicians & over the counter (OTC) medicines available from retail pharmacies are having their own benefits and risks. Regulatory health authority of a country provides marketing authorization for these medicinal products based on their ‘overall’ benefit-risk profile in wide range of populations.
However, the benefit-risk ratio for a medicine which is positive for many patients might become negative for a certain group of patients (due to different age group, risk factors, underling medical conditions, special populations like pregnancy etc.,).
Health care professionals are encouraged to perform assessment for a medicine’s benefit-risk ratio on individual patient basis before prescribing, dispensing, administering the medicine.
With respect to safety of a medicinal product-No medicinal product is having the complete information about its own safety data. In order to hasten the accumulation of safety knowledge of medicines, all health care professionals and patients/consumers are advised to observe, monitor and become aware of the possible adverse drug reactions and report the same to national health authority/pharmacovigilance center of nation.
Reporting channels for notifying the adverse drug experiences/quality complaints to PvPI (Drug safety monitoring center of India) are listed below-
- PvPI Helpline Toll No.1800 180 3024 (Timing: 9.00 AM to 5.30 PM (Monday to Friday))
- Download the android Mobile App “ADR PvPI” which is freely available from Google Play Store.
- The Adverse Events/Adverse Drug Reaction may be reported to nearest Adverse Drug Reaction Monitoring Centers (AMCs), the list of AMCs is available on the website of Indian Pharmacopoeia Commission- http://www.ipc.gov.in/images/LIST_OF_270_AMC_UNDER_PvPI.pdf