Drugs

FDA Says Many Risks Associated with Imprimis Compounded Drugs

FDA says promotional materials for a number of compounded drug products — Dropless products, LessDrops products, Simple Drops products, and Klarity C-Drops product — marketed by Imprimis Pharmaceuticals, San Diego, CA, make many false or misleading claims. The claims establish that the products are drugs, according to a 12/21/17 Warning Letter.

In addition, the letter says, claims for the Simple Drops and Klarity C-Drops represent that they are made with FDA approved components or are FDA-approved, when that is not the case. Further, it says, false or misleading claims about the Dropless, LessDrops, and Simple Drops products omit important risk information, including side effects, contraindications, or consequences that may result from their use.

“These violations are concerning from a public health perspective because they create a false or misleading impression about the safety and effectiveness of these products,” FDA says. “This is especially concerning in light of the many known risks associated with several of the active ingredients in these products, as reflected in the prescribing information for FDA-approved products containing the same active ingredients….”

The letter goes into detail on false or misleading claims, false or misleading risk presentations, and false or misleading efficacy presentations.

Imprimis was told to take prompt action to correct the violations and to respond with a list of specific actions taken with related documentation and a timetable for completion.

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