Drugs

FDA Updated Drug Safety Alert on Heart Drugs

An updated FDA drug safety alert about the safety of some generic versions of angiotensin II receptor blocker (ARB) medicines that contain nitrosamine impurities (N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)), which are probable human carcinogens, has now dismissed significant safety concerns. “We were deeply concerned when we learned about the presence of these impurities,” the alert says. “We immediately undertook a major operation to investigate and to identify the root causes for the presence of these impurities in some ARB drugs, and to work with companies to address the risks that the impurities pose to patients.”

Now, a subsequent analysis of NDMA found that the risk to patients based on the maximum possible exposure “appears to be small,” the agency says. “That doesn’t diminish our concern and our determination to find out how these impurities occurred in the first instance. We’re committed to implementing measures to prevent these impurities from occurring in the manufacturing process in the future. Our ultimate goal is to ensure that these impurities are not present in finished drug products, or their components (including active pharmaceutical ingredients, or API).”

FDA notes that while it still investigates the root causes of the impurities, “our ongoing effort has determined that the impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.”

A 2018 guidance for manufacturers lays out risk assessments that manufacturers can use to evaluate the presence of genotoxic impurities, FDA says. Manufacturers are required to test for known impurities during their manufacturing processes. “Now that we’ve uncovered the risk of nitrosamine impurities in the manufacturing steps involved in ARBs, we’ll incorporate the findings into ongoing policy development,” it adds.

Additionally, agency laboratory staff have “developed and refined novel and sophisticated testing methods specifically designed to detect and quantify the NDMA and NDEA in all ARB medicines,” FDA says. “We’ve shared these tests on our website to help manufacturers and other regulators evaluate these products as well.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome