Weight Loss Drug Voluntarily Withdrawn for Apparent Safety Reasons

The Food and Drug Administration (FDA) is taking final official action withdrawing the approval of two new drug applications for BELVIQ (lorcaserin hydrochloride (HCl)) tablets and BELVIQ XR (lorcaserin HCl) extended-release tablets which were originally approved by FDA on June 27, 2012 and July 15, 2016, respectively.  This announcement was made on the Federal Register’s […]

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Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearth of Evidence for the Effectiveness & Safety of Compounded Bioidentical Hormone Therapy

In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT).  A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]

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REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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Sometimes you get what you pay for; FDA joins forces with India to halt illicit drug sales

The United States Food and Drug Administration and the Indian Government join forces in “Operation Broadsword”.  No, it’s not a trailer for an action thriller, it’s a serious collaboration between two governmental entities to limit the import and sale of illicit drugs to consumers, detailed in FDA’s news release on February 18, 2020 (here). The […]

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What Is It? – Identity Testing Re-visited

In earlier blogs, we have written about specific technical items related to identity testing.  However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

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The “Unwelcome Guest” Spares Metformin

Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here).  Great news!  NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen.  The nitrosamines, including NDMA, […]

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FDA Evaluating Diet Drug Risks for Increase in Cancer Rates

In a January 14, 2020 Drug Safety Communication (here), FDA discusses an alert to patients taking the weight loss drugs Belviq or Belviq XR (lorcaserin) of a potential increase in the risk of cancer.  The NDA drug products were approved on July 27, 2012 (immediate-release) and July 15, 2016 (extended-release version), respectively. The Agency notes […]

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Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern Image

Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern?

I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks (here).  The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no […]

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