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

• Postmenopausal Women Should Not Use the Conjugated Estrogens and Bazedoxifene Combination (DUAVEE)
  (January 2021)
  We previously designated Duavee as “Do Not Use for Seven Years” because, at the time of its approval by the FDA in 2013, it did not represent a clear clinical breakthrough over standard hormone replacement therapy for postmenopausal women. Learn why we have now updated our designation of the drug to Do Not Use.
• Tainted Hand Sanitizers Reinforce Need for FDA Drug-Recall Authority
  (January 2021)
  In his editor’s column, Dr. Michael Carome discusses how unscrupulous companies exploited pandemic-related shortages of hand sanitizers and consumer panic by marketing hand sanitizers that contained dangerous ingredients and thus violated regulatory standards established by the FDA.
• Important Drug Interactions for Angiotensin-Converting Enzyme Inhibitors
  (January 2021)
  Patients taking the widely prescribed angiotensin-converting enzyme (ACE) inhibitors, such as benazepril (LOTENSIN) and lisinopril (PRINIVIL, QBRELIS, ZESTRIL), should be aware that these medications have clinically important interactions with many other prescription and over-the-counter medications.
• Common Antidepressants Carry Very Small Risk of Birth Defects
  (January 2021)
  In this article, we review results of a new study that sheds further light on the association between the use of specific antidepressants during early pregnancy and the small risk of birth defects.
• New Research Finds Commonly Used Gout Drug Not Useful for Slowing the Progression of Chronic Kidney Disease
  (January 2021)
  Results of two recently published large, well-designed, randomized clinical trials provide important new evidence against using allopurinol (LOPURIN, ZYLOPRIM) to slow the rate of kidney function decline in patients with chronic kidney disease, a use of the drug that is not approved by the FDA.

  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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• Press Statement: FDA Must Demand a New Clinical Trial of Experimental Alzheimer’s Disease Treatment Following Inappropriate Collaboration (HRG Publication #2567) (January 29, 2021)
  The FDA must reject the current application for aducanumab and demand that Biogen and Eisai conduct another large, placebo-controlled clinical trial before giving further consideration to approving aducanumab to treat Alzheimer’s disease. Additional flawed statistical analyses of data from the previously conducted trials of the drug will not be sufficient to establish that the drug is effective.
• Follow-up Letter to the FDA’s Acting Commissioner Regarding the Agency’s Inappropriate Close Collaboration with Biogen on the Alzheimer’s Disease Drug Aducanumab (HRG Publication #2566) (January 28, 2021)
  Public Citizen urged the FDA’s new Acting Commissioner to endorse our call for the Department of Health and Human Services’ Office of Inspector General to investigate the unprecedented and inappropriate close collaboration between the FDA and Biogen before and after the submission of the company’s biologics license application (BLA) for the new drug aducanumab for treatment of Alzheimer’s disease.
• Letter to Senior FDA and NIH officials Urging Changes to the Fact Sheets for Recipients of the Recently Authorized COVID-19 Vaccines (HRG Publication #2564) (December 22, 2020)
  Public Citizen strongly urged senior Food and Drug Administration (FDA) and National Institutes of Health (NIH) officials to promptly update the Pfizer-BioNTech and Moderna-NIH COVID-19 vaccine fact sheets for vaccine recipients and caregivers to include statements advising vaccine recipients to continue to follow the proven public health measures of mask wearing and social distancing.
• Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Moderna-NIH COVID-19 Vaccine (HRG Publication #2563) (December 17, 2020)
  In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Moderna-NIH COVID-19 vaccine, but argued that the fact sheet for recipients of the vaccine should advise recipients to continue following public health guidelines for wearing masks and other personal protective equipment and for social distancing to prevent transmission of the coronavirus.
• Testimony Before the FDA’s Vaccines and Related Biological Products Advisory Committee Regarding the EUA of the Pfizer-BioNTech COVID-19 Vaccine (HRG Publication #2562) (December 10, 2020)
  In testimony before a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, Public Citizen agreed with the need for an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, but argued that for ethical reasons, subjects in the placebo group for the pivotal clinical trial should be offered the opportunity to be unblinded, receive the Pfizer vaccine, and continue to be followed in the trial for long-term safety and efficacy assessments.