• FDA Warns Against Using NSAIDs in Pregnancy at 20 Weeks or Later (November 16, 2020)
• FDA Warns Consumers Not to Use Dangerous Black Salve or Similar Products (October 15, 2020)

  View the entire November 2020 issue in PDF format

• Hydroxychloroquine and Chloroquine: Failed Remedies for COVID-19
  (November 2020)
  Early during the coronavirus pandemic, hydroxychloroquine and chloroquine were considered potentially useful treatments for COVID-19. In this article, we discuss results of randomized clinical trials showing that hydroxychloroquine is not effective for treating or preventing COVID-19.
• Leading Generic Drug Manufacturer Indicted by Feds for Price Fixing
  (November 2020)
  In his editor’s column, Dr. Michael Carome discusses U.S. Department of Justice charges brought against generic drug maker Teva for engaging in illegal price-gouging schemes for multiple prescription drugs.
• Nitrosamine Impurities in Medications
  (November 2020)
  Since 2018, the FDA has found that certain commonly used medications contained unacceptable levels of nitrosamine impurities (contaminants) that are considered probable human carcinogens. Learn about the risks of nitrosamines and specific drugs that have been found to be contaminated with these compounds.
• New Research Finds Folic Acid and Zinc Supplementation in Men Not Effective for Treating Infertility
  (November 2020)
  Supplements for male fertility often contain folic acid and zinc, likely because both substances have been shown to play key roles in the formation and maintenance of normal healthy sperm. However, data from a recently published clinical trial funded by the National Institutes of Health showed supplementation with folic acid and zinc in men among couples undergoing infertility treatment does not increase the chances of achieving a successful pregnancy.
• Highlights of the New Guidelines for Severe Allergic Reaction
  (November 2020)
  We review new guidelines for treating life-threatening allergic reactions (known as anaphylaxis) recently issued by the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma and Immunology.
• Question & Answer
  (November 2020)
  In this month’s Question & Answer feature, we respond to a reader’s question asking about our recommended alternatives to the opioid analgesic tramadol (CONZIP, ULTRACET, ULTRAM), which we have designated as Do Not Use.

  View the entire October 2020 issue in PDF format

• Public Citizen Calls on FDA to Require Black-Box Warning for Newest Diabetes Drugs
  (October 2020)
  Learn why patients with type 1 diabetes should never use any of the type 2 diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which are often referred to as “flozins” or “gliflozins.”
• “Male-Enhancing” Dietary Supplements Were Tainted With Dangerous Drugs
  (October 2020)
  In his editor’s column, Dr. Michael Carome discusses a recent report published in Morbidity and Mortality Weekly Reports that hammers home the potentially life-threatening dangers of using these illegal dietary supplements.
• Gabapentinoid Drug Use Is Exploding Despite Poor Safety and Efficacy Profiles
  (October 2020)
  Marked increases in the prescribing of the gabapentinoids gabapentin and pregabalin, particularly for uses not approved by the FDA (so-called off-label uses), indicate that these drugs are widely overprescribed and misused in the U.S. In this article, we review three recent studies that characterized the growth and extent of gabapentinoid overuse during the past two decades.
• Adults Often Inadvertently Put Children at Risk of Oral Medication Poisoning, Study Finds
  (October 2020)
  Ingestion of prescription medications or over-the-counter products is a common cause of poisoning among children. A recently published study found that adults frequently are to blame for this avoidable problem.
• Important Drug Interactions for the Stomach-Acid–Suppressing Drug Omeprazole
  (October 2020)
  Patients taking the commonly used stomach-acid–suppressing drug omeprazole should be aware that it has clinically important interactions with many other prescription medications.
• News Brief: Shortages in Albuterol Asthma Inhalers During the COVID-19 Pandemic
  (October 2020)
  In this month’s news brief, we report on shortages of the inhaled asthma drug albuterol that have occurred because of the coronavirus pandemic.

  View the entire September 2020 issue in PDF format

• Key Takeaways From the Updated CDC Report on Antibiotic Resistance
  (September 2020)
  An updated report from the Centers for Disease Control and Prevention underscores the continued threat of antibiotic resistance in the U.S. and highlights the emerging areas of concern and actions needed to combat this major public health problem.
• Evidence Lacking to Support Use of Compounded Topical Pain Creams
  (September 2020)
  In recent years, there has been a surge in the use of compounded topical pain creams as an alternative to oral pain medications, such as non-steroidal anti-inflammatory drugs and opioids. However, a committee of experts convened by the National Academies of Sciences, Engineering, and Medicine recently concluded that there is a lack of evidence to support the safety and effectiveness of these compounded products.
• Testosterone Therapy for Men: More Evidence of Blood Clot Risk
  (September 2020)
  In this article, we discuss the results of a recent large observational study that provide added support for the concern that testosterone therapy heightens the risk of dangerous blood clot formation.
• Review of Phenytoin, a Best Pill for Seizures
  (September 2020)
  Medications are the mainstay of treatment for most patients with seizure disorders, and more than two dozen such drugs have been approved by the FDA. We review one of the oldest seizure drugs, phe¬nytoin (DILANTIN, PHENYTEK). Patients using the drug need to be aware of its many potentially serious adverse effects.
• Driving Under the Influence Caused by Medications
  (September 2020)
  Although impaired driving usu¬ally is caused by alcohol or marijuana, many commonly used prescription and over-the-counter medications also can impair one’s ability to drive safely. Learn about several classes of medications that can cause this serious problem to protect yourself, your passengers and others who share the road with you.

   View back issues January 2004 - present

• Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Combination Drug Olanzapine/Samidorphan Intended to Treat Schizophrenia and Bipolar Disorder (HRG Publication #2548) (October 9, 2020)
  In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of the combination drug olanzapine/samidorphan, which is intended to treat schizophrenia and bipolar disorder, because the samidorphan component is only marginally effective in decreasing the weight gain seen with olanzapine, fails to improve many other indicators of metabolic health, and
• Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding an Oral Amphetamine Product Intended to be Abuse-Deterrent (HRG Publication #2547) (October 8, 2020)
  In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, Public Citizen argued against approval of AR19, an oral amphetamine product that is intended to be abuse-deterrent, because studies show that the drug is not expected to reduce abuse by injection or intranasal routes.
• Comments on the FDA’s Proposal to Exclude 19 Bulk Drug Substances From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2545) (September 29, 2020)
  Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to exclude 19 bulk drug substances from the list of bulk drug substances for which there is a clinical need under Section 503B of the Federal Food, Drug, and Cosmetic Act for pharmacy compounding by outsourcing facilities.
• Testimony Before the FDA’s Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee Regarding Reformulated Oxycontin (HRG Publication #2543) (September 11, 2020)
  In testimony before a joint meeting of the Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee Anesthetic and Analgesic Drug Products Advisory Committee, Public Citizen emphasized that there is a serious question as to whether introducing abuse deterrent opioids such as reformulated Oxycontin (oxycodone) may have worsened overall public health.