Metoprolol Fumarate

New Delhi: The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Union Health Ministry, has issued a warning regarding beta-blockers , commonly prescribed drugs for conditions like irregular heartbeat and hypertension. The warning highlights a rare but potentially serious risk of low potassium levels , known as hypokalaemia , associated with these medications, a TOI report stated. IPC's drug safety alert In its latest drug safety alert, the IPC noted, "Healthcare professionals, patients/consumers are advised to closely monitor the possibility of the above adverse drug reaction with the use of above suspected drugs." The alert also urged healthcare providers and patients to report any suspected adverse drug reactions to the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI). PvPI is a government initiative aimed at monitoring drug safety and reducing risks associated with medication use. Drugs under scrutiny The alert specifically mentioned beta-blockers such as Metoprolol, Propranolol, and Atenolol. These medications are widely used to manage heart conditions and hypertension. While the risk of hypokalaemia is described as rare, the condition can lead to severe complications, including irregular heartbeat and sudden palpitations. Expert opinion on the risk Cardiologists have emphasized the rarity of hypokalaemia linked to beta-blockers. "Hypokalaemia can cause irregular heartbeat, sudden palpitations and other life-threatening complications. But we don't see it often," said Dr. Mohit Gupta, a professor of cardiology at Delhi's G B Pant Hospital. Dr. Gupta advised caution for elderly patients and those using diuretics, as they may have a higher risk of developing low potassium levels when using beta-blockers. He also noted that beta-blockers should not be the first line of treatment for non-critical conditions like high blood pressure . Advisory for patients The IPC clarified that its alert is advisory in nature and not a cause for panic. "People using beta-blockers should not be alarmed as hypokalaemia is extremely rare in such cases," Dr. Gupta stated. Patients are encouraged to consult their healthcare providers for guidance and to report any unusual symptoms or adverse reactions.

Dr Reddy’s Laboratories, Glenmark Pharma, and Zydus are recalling products in the US market for manufacturing issues, according to the US Food and Drug Administration (USFDA). In its latest enforcement report, the US health regulator said Princeton-based Dr Reddy’s Laboratories, Inc., a unit of the Hyderabad-based drug firm, is recalling 1,656 bottles of Montelukast sodium tablets. The product is indicated to prevent wheezing, breathing difficulty, chest tightness, and coughing caused by asthma in adults. As per the USFDA, the company is recalling the affected lot due to the presence of foreign tablets and capsules. A foreign tablet was found in a bottle of Montelukast sodium tablets, USP 10mg, identified as metoprolol 25 mg, it added. The company initiated the Class II voluntary recall on October 13. The USFDA noted that Mahwah-based Glenmark Pharmaceuticals Inc, USA, a unit of Mumbai-based Glenmark Pharma, is recalling 5,856 bottles of Deferasirox tablets for oral suspension. The product is used to treat hemochromatosis, or iron overload in the blood. The company is recalling the affected lot due to "failed dissolution specifications," the USFDA noted. The company initiated the Class II recall on October 20.