A new drug safety alert (Hydroxychloroquine-Moth Ulceration) released by the Pharmacovigilance Programme of India (PvPI) from Indian Pharmacopoeia commission (IPC)

Mouth Ulceration associated with Hydroxychloroquine use

Hydroxychloroquine is an antimalarial class of drug which is used in the treatment and prevention of acute attacks of malaria. It also used to treat discoid or systemic lupus erythematosus, rheumatic disorders like rheumatoid arthritis, porphyria cutanea tarda and Q fever.

Hydroxychloroquine became popularized all over the globe due to publication of some research studies on its efficacy for COVID-19 treatment. Use of Hydroxychloroquine for treating patients with Corona virus infection is an “not approved’ by any national regulatory body. However, due to this pandemic disease, national health and regulatory bodies allowed the use of this potential drug in COVID-19 patients as off-label use (used for unapproved indication) and also few clinical studies underwent for evaluating the efficacy and safety of Hydroxychloroquine in treating Corona virus infection.

USFDA provided emergency use authorisation (authorization for temporary use during the COVID-19 pandemic for treatment of the hospitalized patients with COVID positive, when clinical trials are not available, or participation is not feasible) for this drug in March 2020. Despite Hydroxychloroquine’s potential in treatment of corona virus, there are serious safety concerns for this drug, which included abnormal heart rhythms like QT prolongation and ventricular tachycardia which are sometimes life threatening to patients. On 24-Apr-2020, USFDA announced a caution on this potential COVID-19 medication due to serious safety concerns of QT interval prolongation and ventricular tachycardia.

With an exponential increase in the use of this drug for COVID-19 patients globally, the possibility of finding new safety concerns and identification of increased reporting (frequency) and changes in severity (fatal and life threatening) for expected safety concerns for this drugs is increased.

PvPI (Pharmacovigilance Programme of India)-which is actively conducting postmarketing drug safety surveillance in India has received significant number of case reports from the public for the Drug-ADR combination of Hydroxychloroquine and Mouth Ulceration. PvPI advised Healthcare Professionals, COVID-19 patients and other consumers to closely monitor the possibility of this adverse reaction and to report the nearest Adverse Drug Reaction Monitoring Centers (AMC) or directly to national coordinating center of PvPI through Android Mobile App “ADR PvPI App” [or] through PvPI Helpline No. 1800-180-3024.

Case reports in FAERS:

FDA Adverse Event Reporting System (FAERS), the post marketing surveillance system for United States-FDA has a total of 247 case reports of mouth ulceration associated with Hydroxychloroquine use. Highest number of cases (110) were received in the last year-2019. There are total 36 case reports received so far in 2020 (as of 31 Mar 2020).

Case distribution:

By age group: Paediatric (1); Adult (162); Elder (22); Not Specified (62)

By gender: Female (232); Male (09); Not Specified (6)

By reporter type: Health care professional (179); Consumer (62); Not Specified (6)

Case reports in VigiBase:

In the global drug safety database-VigiBase (Maintained by WHO-UMC), the total number of case reports with this Drug-ADR combination of Hydroxychloroquine and Mouth Ulceration are 40 which were originated from different countries (member countries for the international drug safety monitoring).

Voluntary Reporting:

Voluntary reporting of medicine side effects

Voluntary reporting of medicine side effects

The Prophylactic use (and off-label use) of Hydroxychloroquine to be coupled with the adverse drug reactions reporting using the various reporting channels provided by PvPI.

As the nation is facing a huge challenge to fight against the COVID-19 from spreading across the communities, therefore during the prophylactic use of hydroxychloroquine if any adverse event is encountered by the patients, such adverse events may be reported by the Patients themselves or by the Health Care Professionals with the below available reporting channels:

  • PvPI Helpline No.1800 180 3024 (Timing: 9.00 AM to 5.30 PM (Monday to Friday))
  • Android Mobile App “ADR PvPI” which is freely available from Google Play Store.
  • The Adverse Events/Adverse Drug Reaction may be reported to nearest 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
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