Drugs

Change Epinephrine Sulfite Warning: Belcher

Belcher Pharmaceuticals is asking FDA to amend its sulfite warning requirement for sulfite-containing injectable epinephrine used in emergency situations “to remove misleading information and acknowledge the current availability of approved epinephrine products that do not contain sulfite.” Belcher produces a sulfite-free epinephrine injection.

The company’s 5/25 petition says that its product was approved 7/29/14 and is now commercially available as an alternative to sulfite-containing epinephrine products including metabisulfite-containing Adrenalin (Par Sterile Products’ epinephrine HCl), and sulfite-containing products that are unapproved. It says that the current warning is misleading to doctors in implying that the only alternatives to the sulfite-containing epinephrine product are non-epinephrine products.

“The existing language is outdated because it fails to provide a third option to physicians, that of sulfite-free epinephrine,” the petition says. “By failing to mention this third option, the existing language implies that no sulfite-free formulation of epinephrine exists, which is untrue. The warning also misleadingly suggests that allergic-type reactions caused by a sulfite only occur ‘in other products’ and do not occur in the sulfite-containing epinephrine products. We are aware of no data demonstrating that such reactions cannot occur in patients receiving epinephrine injections. Because sulfite sensitivity generally cannot be determined before treatment in emergency situations, it is medically inappropriate to administer sulfite-containing formulations of epinephrine when a sulfite-free formulation of epinephrine is available.”

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