New Delhi: The Indian Pharmacopoeia Commission (IPC), a body under the health ministry, has named five lifesaving drugs as having shown serious side effects.
The drugs are Metronidazole, an antibiotic; Luliconazole, an antifungal; Dalteparin, used for cancer treatment; diabetics drug Gliclazide and Tramadol, a painkiller.
During a recently conducted analysis of adverse drug reactions (ADRs), the commission found that the use of these drugs can cause severe reactions, including muscle spasms.
The government body has asked the and patients to report any adverse events associated with the use of the drugs to the authorities.
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“The analysis of adverse drug reactions from Pharmacovigilance Programme of India database revealed that Metronidazole, Luliconazole, Dalteparin, Gliclazide, Tramadol to cause adverse drug reaction,” stated the IPC’s drug safety alert reviewed by Mint.
“Healthcare professionals, patients or consumers are advised to closely monitor the possibility of the above ADR associated with the use of above suspected drug. If such a reaction is encountered, please report to the IPC,” it said.
An ADR is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs.
The IPC said Metronidazole is a commonly used antibiotic for the treatment of amoebiasis, an intestinal and extraintestinal disease, urogenital trichomoniasis in women and giardiasis, an intestinal infection. However, using Metronidazol can also cause acute generalized exanthematous pustulosis (AGEP), a rare, severe cutaneous adverse reaction.
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Luliconazole, an antifungal drug used for the treatment of fungal skin infections, can cause a chloasma—a common skin condition causing dark patches.
Similarly, Dalteparin, an anticoagulant used for the treatment of deep vein thrombosis and to reduce the recurrence of venous thromboembolism in patients with cancer, was found to cause muscle spasms.
Gliclazide, primarily used for diabetes without or with obesity in adults, was found to cause erythema multiforme (EM), a skin condition. Similarly, Tramadol, a pain relief drug, is found to have caused fixed drug eruption, a kind of skin reaction.
The IPC monitors adverse drug reactions among the Indian population and helps the Central Drugs Standard Control Organisation (CDSCO) in taking regulatory decisions for safe use of medicines.
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“For the public, this should not be a cause for concern. These medications are well-established and widely used. While rare side-effects can occasionally be identified, we must not forget that the overwhelming majority of patients remain safe and also benefit from them,” said Dr Rajeev Jayadevan, president of the Indian Medical Association, Cochin chapter.
Queries sent to the health ministry remained unanswered till press time.