More on the ARB RecallsDecember 5th, 2018 | Clinical Connections•News
Irebesartan and losartan combo product: The FDA has issued a recall on several irbesartan products, one lot of losartan-HCTZ 100/25. Similar to valsartan, these products are being recalled as trace amounts of a potential carcinogen has been detected in certain lots. The full FDA release is available here.
– As of now, the losartan recall only impacts a single lot of losartan-HCTZ 100/25 that was distributed after 10/8/18. As with the valsartan recall, it is possible that the list of recalled products will be expanded in the future. It is important to note the manufacturer issuing the recall produces <1% of losartan products in the US market. - As of now, the recalls are at the distributor level, meaning pharmacies are not required to contact patients who received recalled products. The valsartan recall was initiated at the distributor level but ultimately elevated to consumer level. - Wegmans Pharmacy has confirmed they are not impacted by the losartan/HCTZ recall. Valsartan and valsartan combo products: The valsartan recall has been expanded to include additional lots of valsartan, amlodipine/valsartan, and amlodipine/valsartan/HCTZ products. This recall was initiated for the same reason as the prior ARB recalls (presence of an impurity classified as a “probable carcinogen”). The FDA release states manufacturers will be contacting patients who received affected products. Full information here and here.
*Dosing conversions are estimates derived from clinical trial data. When converting between agents, select a conservative dose for frail/elderly patients or those at risk for hypotension or falls. Example: An 89 year old female on losartan 50 mg/day for HTN. Last home BP 100/70. Stop losartan and start lisinopril 5 mg daily x 5 days. Have patient call with BPs and increase dose as needed.
Article Credit: Jineane Venci, PharmD, MS-CI, BCACP