Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To amlodipine and acetazolamide

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of June, has revealed adverse drug reactions linked with amlodipine and acetazolamide.

In accordance with the drug safety alert, amlodipine causes lichenoid keratosis, which is an inflammatory reaction arising in a regressing existing solar lentigo or seborrhoeic keratosis.

In connection with the above, the Indian Pharmacopoeia Commission (IPC) has cautioned healthcare professionals to diligently monitor the potential occurrence of adverse drug reactions (ADRs) when administering amlodipine and acetazolamide.

Furthermore, the alert stated that acetazolamide, a medication used to treat glaucoma, epilepsy, acute mountain sickness, periodic paralysis, idiopathic intracranial hypertension, heart failure, and to alkalinize urine, may lead to choroidal effusion or choroidal detachment.

This came after a preliminary analysis of adverse drug reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

Amlodipine is a calcium channel blocker used to treat hypertension and angina. In line with the drug safety alert, amlodipine is used to reduce fatal coronary heart disease, non-fatal myocardial infarction, and to reduce the risk of stroke. Furthermore, it added that amlodipine is indicated to reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery diseases.

On the other hand, acetazolamide is a carbonic anhydrase inhibitor used to treat edema from heart failure or medications, certain types of epilepsy, and glaucoma. The anticonvulsant activity of acetazolamide may depend on a direct inhibition of carbonic anhydrase in the CNS, which decreases carbon dioxide tension in the pulmonary alveoli, thus increasing arterial oxygen tension. The diuretic effect depends on the inhibition of carbonic anhydrase, causing a reduction in the availability of hydrogen ions for active transport in the renal tubule lumen. This leads to alkaline urine and an increase in the excretion of bicarbonate, sodium, potassium, and water.

As per the drug safety alert, acetazolamide is indicated as an adjunct in the treatment of chronic open-angle glaucoma, secondary glaucoma, and as part of the preoperative treatment of acute-angle closure glaucoma.

Following the preliminary analysis of adverse drug reactions (ADRs) from the PvPI database, it is reported that amlodipine can cause lichenoid keratosis, also known as, keratosis lichenoides chronica, a condition where, usually, a solitary brown lesion turns red and becomes itchy. These lesions usually appear in an area that is exposed to the sun. They generally appear most on the forearms, hands, or chests of middle-aged white women.

Additionally, preliminary research on adverse drug reactions (ADRs) from the PvPI database indicates that acetazolamide may lead to choroidal effusion or choroidal detachment. Choroidal detachment is a detachment of the choroid from the underlying sclera due to the accumulation of fluid in the suprachoroidal space, generally due to increased intraocular pressure (IOP).

Now, as per the issued drug safety alert, the following suspected drug is associated with the ADRs, as given below:

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, has advised healthcare professionals, patients, and consumers to closely monitor the possibility of the above ADRs associated with the use of the above suspected drugs.

Further, the safety alert added, "If such reaction is encountered, please report to the NCC-PvPI, IPC, by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App "ADR PvPI App" and PvPIHelpline No. 1800-180-3024 (toll-free)."

To view the official notice, click the link below: