PvPI-Pharmacovigilance Programme for India is a national drug safety monitoring center for India maintained by Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. PvPI is responsible for Public Pharmacovigilance activities which included collection of safety information, detection, assessment, understanding and prevention of safety concerns associated with medicinal products used by Indian citizens.
As part of routine analysis of individual case safety reports (adverse drug event (AE)/adverse drug reaction (ADR)/product quality complaints/medication error case reports from patients) originated from India, PvPI has identified and released the following two new drug safety alerts for the month of August & September-2020 to alert the health care professionals and public to monitor for these adverse drug reactions for improving patient safety and overall public health. The two drug safety alerts were described in brief here below-
Drug Safety Alert 1: Photosensitivity reaction associated with Pramipexole
Drug Safety Alert 2: Intracranial/Pulmonary Hypertension associated with Fluvoxamine
Drug Safety Alert 1: Photosensitivity reaction associated with Pramipexole
Pramipexole is a dopamine agonist used in the treatment of restless leg syndrome (RLS) and Parkinson’s disease. Photosensitivity reactions are immune system reactions which are triggered by exposure to sunlight. Common photo-allergic reactions are itching, burning sensation, rashes etc., which are developed due to photochemical reaction between certain medications and sunlight.
Why photosensitivity reactions occur?
Ultraviolet radiation from sunlight triggers the immune system of body to see the drug as an antigen (foreign body) and initiates the allergic response which in turn causes inflammation, rash, and other photo allergic reactions to the areas of body which are exposed to sunlight. Some of the class of medications which have potential to cause photosensitive reactions are antibiotics, antihistamine drugs, HMG-CoA reductase inhibitors, anti fungal drugs etc.,
As per the current safety knowledge of pramipexole, photosensitivity reactions are not well documented. In European Summary of product characteristics (SmPC), no safety information was presented relevant to photosensitivity reactions associated with pramipexole. As per the United States Prescribing information for Mirapex® (brand name for pramipexole) photosensitivity allergic reactions are documented under adverse drug reactions observed during phase 2 and 3 clinical trials. From the medical literature, there is a case report concerning 45-year-old male farmer who developed maculopapular erythematous rash (a photosensitivity reaction) in the areas which are sun-exposed within 8 days after treatment with pramipexole for restless leg syndrome.
From the preliminary analysis of adverse drug reactions (ADRs) present in VigiFlow (ICSR database maintained by NCC-PvPI) received from Indian Patients through spontaneous ADR reporting system, PvPI identified this drug-ADR combination of “pramipexole-photosensitivity reactions” and alerted health care professionals for the same to monitor and implement measures to minimize the occurrence of this known risk.
Important information to Healthcare professionals:
- To be aware of photosensitivity reactions associated with pramipexole treatment associated with sunlight exposure having higher UV radiations.
- To inform/educate and advise patients to prevent/minimize exposure to sunlight during treatment with pramipexole.
- To closely monitor the patients for the possible occurrences of any photo-allergic/photosensitive reactions and report the same to respective national health authority.
Drug Safety Alert 2: Intracranial/Pulmonary Hypertension associated with Fluvoxamine
Fluvoxamine is an antidepressant medication which comes under the class of Selective Serotonin Reuptake Inhibitor (SSRI). This drug is mainly used for the treatment of obsessive-compulsive disorder, OCD (an anxiety disorder which involves undesirable thoughts which are recurring and ideas or obsessions to do repetitive behaviours).
Intracranial hypertension is a serious concern which causes severe headache and visual loss. This usually occurs when these is high pressure in the cerebrospinal fluid, CSF (a fluid which surrounds the brain). Elevated CSF pressure could lead to permanent visual loss. Pulmonary hypertension is the increased blood pressure in the arteries of lungs and at the right side of the heart. Pulmonary hypertension causes narrowing of blood vessels present in lungs which can be blocked or destroyed. Symptoms of Pulmonary hypertension causes included Shortness of breath, dizziness, and chest pressure.
The safety findings- ‘Intracranial hypertension and pulmonary hypertension’ are not well documented as per the United States Prescribing information document for LUVOX CR® (brand name for Fluvoxamine). In the European SmPC for Fluvoxamine, these safety concerns were not described. However, the risk of persistent pulmonary hypertension in the newborn (PPHN) was documented under warning & precautions and use in special populations sections of prescribing information and SmPC.
From the preliminary analysis of ADRs present in VigiFlow, PvPI identified this drug-ADR combination for “Fluvoxamine-Intracranial/Pulmonary Hypertension” and alerted health care professionals for the same to monitor and implement measures to minimize the occurrence of this known risk.
Important information to Healthcare professionals:
- To be aware of Intracranial/Pulmonary Hypertension associated with the Fluvoxamine in patients under OCD treatment.
- To inform/educate and advise patients to closely monitor for any signs and symptoms of these findings such as shortness of breath during routine activity, chest pressure, dizziness, fast heart rate, fatigue, inability to exercise, low blood pressure, swollen legs, headache, vomiting, ringing in the ears, blurred vision etc.,
- To closely monitor the patients for the possible occurrences of any of the above signs and symptoms of intracranial/pulmonary hypertension and report the same to respective national health authority.