Drugs

Don’t Use 2 HelloCig E-Liquids: FDA

FDA is warning consumers that two e-liquids sold by HelloCig Electronic Technology Co. contain undeclared prescription drug active ingredients. An agency alert says that the “E-Cialis HelloCig E-liquid” contains sildenafil and tadalafil, while the “E-Rimonabant HelloCig E-liquid” contains sildenafil. FDA says the undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Sildenafil and tadalafil are active ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. They are not approved for inclusion in e-liquid products sold over the counter and therefore are being sold illegally, FDA says.

The notice says FDA warned the company about the issues and several times recommended that it recall the products due to risks to consumes, but the company has not responded to the agency recommendations. It therefore is urging consumers not to use the products.

FDA says it is not aware of any adverse events associated with use of HelloCig products.

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