Drugs

NDMA Testing on Ranitidine Better Than First Thought: FDA

An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine (NDMA) found in ranitidine (Zantac) says that preliminary testing on numerous ranitidine products has found NDMA levels that are similar to levels consumers would normally be exposed to in foods like grilled or smoked meats. “We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process,” CDER director Janet Woodcock said in the update. “Similarly, if ranitidine is exposed to a simulated small intestine environment, NDMA is not formed. However, we still must test the drugs in the human body to fully understand if ranitidine forms NDMA.”

Woodcock said FDA’s testing found NDMA levels much lower than the levels some third-party scientists first claimed, but some levels still exceed what the agency considers acceptable. “If we or the manufacturers find NDMA levels above the acceptable limits (96 nanograms per day or 0.32 ppm), we're now asking companies to voluntarily recall ranitidine,” she said. “We would also ask manufacturers to voluntarily recall nizatidine, commonly known as Axid, if they found NDMA above the acceptable daily intake level because it is chemically similar to ranitidine.”

FDA is still asking manufacturers to continue conducting their own laboratory testing to determine NDMA levels in ranitidine and nizatidine as well as to send samples to FDA to be tested by our scientists. “We are still working with manufacturers to investigate the true source of NDMA and to understand the root cause of the low levels of NDMA present in the drugs,” Woodcock said.

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