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  View the entire February 2021 issue in PDF format

  • Overview of the Questionable Drug Andexanet (ANDEXXA)
    (February 2021)
    Andexanet (ANDEXXA) received accelerated approval from the FDA for emergency reversal of life-threatening or uncontrolled bleeding caused by the use of two new oral anticoagulants: apixaban (ELIQUIS) and rivaroxaban (XARELTO). Learn why we have designated andexanet and these two anticoagulants as Do Not Use.
  • Our Current Views on the First Two FDA-Authorized COVID-19 Vaccines
    (February 2021)
    In his editor’s column, Dr. Michael Carome explains why we encourage readers eligible to receive either of the first two COVID-19 vaccines granted Emergency Use Authorizations by the FDA to get vaccinated when the vaccines become available.
  • Reformulated OxyContin Fails to Show Less Abuse 10 Years After FDA Approval
    (February 2021)
    In this article, we review four postmarketing studies Purdue Pharma submitted to the FDA that evaluated the alleged abuse-deterrent properties of the company’s reformulated OxyContin and the agency’s independent assessment of the studies’ results. The data failed to show any meaningful reductions in overall opioid abuse or overdoses since the reformulated Oxycontin was approved in 2010.
  • Drugs That Cause Magnesium Deficiency
    (February 2021)
    Magnesium deficiency, due to either inadequate dietary intake, impaired intestinal absorption or excessive urinary loss of the mineral, results in low blood magnesium levels — a condition known as hypomagnesemia — and a wide range of adverse health effects. Importantly, many commonly used drugs also can cause magnesium depletion.
  • High-Dose Biotin Supplements Can Cause Inaccurate Laboratory Test Results
    (February 2021)
    Dietary supplements that contain more than the recommended daily intake of biotin, also known as vitamin B7, can significantly interfere with many important clinical laboratory blood tests (including those for heart disease and thyroid problems), falsely altering their results. Incorrect test results can lead to misdiagnosis and inappropriate treatment of health conditions, which may have serious or even deadly consequences.
  • News Brief: Non-melanoma Skin Cancer Warning Added to Hydrochlorothiazide Drug Label
    (February 2021)
    In this month’s news brief, we report on FDA-required changes to the product labeling for hydrochlorothiazide (MICROZIDE), a thiazide diuretic drug (“water pill”), warning about a small increased risk of non-melanoma skin cancer associated with use of the drug.

  View the entire January 2021 issue in PDF format

  View the entire December 2020 issue in PDF format

  • Alcohol and Benzodiazepines Commonly Co-Involved in U.S. Opioid Overdose Deaths, Study Finds
    (December 2020)
    Combining opioids with other central nervous system depressants — mainly alcoholic beverages or benzodiazepines — greatly increases the risk of opioid overdose and death. These dangers are highlighted by new research showing that alcohol and benzodiazepines were commonly co-involved in U.S. opioid overdose deaths in recent years.
  • Maker of “Female Viagra” Deceives Women With Misleading Radio Ad
    (December 2020)
    In his editor’s column, Dr. Michael Carome discusses a recent FDA warning letter to Sprout Pharmaceuticals accusing the company of airing of an illegal radio ad that made “false or misleading claims about the risks” associated with flibanserin (ADDYI) — a drug intended to increase sexual desire in premenopausal women with hypoactive (low) sexual desire disorder that is often erroneously dubbed the “female VIAGRA” and that we have designated as Do Not Use.
  • Dexamethasone: A Marginally Beneficial Treatment for Severe COVID-19
    (December 2020)
    In this article, we review the results of randomized clinical trials showing that the anti-inflammatory corticosteroid dexamethasone reduces the risk of death in patients hospitalized with COVID-19 who require supplemental oxygen or mechanical ventilation.
  • Important Drug Interactions for the Calcium Channel Blocker Diltiazem
    (December 2020)
    Patients taking the widely prescribed calcium channel blocker diltiazem (CARDIZEM, CARTIA XT, TAZTIA XT, TIAZAC) should be aware that it has clinically important interactions with many other prescription medications.
  • Liraglutide (SAXENDA): The Wrong Choice for Weight Loss
    (December 2020)
    Find out why the FDA-approved high-dose form of liraglutide, which was originally marketed at a lower dose for treatment of type 2 diabetes, is not a safe option for managing weight loss.
  • Question & Answer
    (December 2020)
    In this month’s Question & Answer feature, we respond to a reader’s question about whether the risks of montelukast (SINGULAIR) outweigh its benefits when it is used for chronic obstructive pulmonary disease (COPD).

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