• FDA Announces Discovery of Cancer-Causing Contaminant in Heartburn Medication (September 20, 2019)

  View the entire December 2019 issue in PDF format

• Commonly Used Oral Drugs That Can Cause Eye Problems; First of a Two-Part Series
  (December 2019)
  In this first of a two-part series, we review some of the many commonly prescribed medications that can damage your eyes and the steps that you can take to protect yourself from these adverse effects. The second part in this series will appear in our February 2020 issue.
• Reckless Failure to Identify Dangerous Adverse Effect of New Diabetes Drugs
  (December 2019)
  In his editor’s column, Dr. Michael Carome discusses the failure of drug companies, researchers and the FDA to recognize the overwhelming evidence dating back to the early 1900s demonstrating that the new diabetes drugs known as “flozins” can cause life-threatening ketoacidosis.
• Important Drug Interactions for the Antifungal Drug Fluconazole
  (December 2019)
  Patients taking the commonly prescribed antifungal drug fluconazole (DIFLUCAN) should be aware that it has clinically important interactions with many other prescription medications. Some of these interactions can lead to an increased risk of fatal heart rhythm abnormalities.
• New Research Shows Vitamin D Supplements Not Useful for Preventing Cancer, Cardiovascular Disease or Diabetes
  (December 2019)
  Learn about results of two large, well-designed, randomized clinical trials funded by the National Institutes of Health demonstrating that high-dose vitamin D supplementation was not useful for preventing cancer, cardiovascular disease or diabetes.
• New Study Finds Higher Risk of Psychosis with Amphetamine Treatment for ADHD
  (December 2019)
  Read this article to find out which drug treatment for attention deficit hyperactivity disorder has a greater risk of psychosis in adolescents and young adults.
• Question & Answer
  (December 2019)
  Read our response to a reader who asked whether the drug pantoprazole (PROTONIX), which suppresses stomach acid, could have caused a false-positive urine screening test result for tetrahydrocannabinol (THC) — the chemical responsible for most of marijuana’s psychological effects.

  View the entire November 2019 issue in PDF format

• Review of the Diet Drug Orlistat
  (November 2019)
  Learn about the many dangers that make the diet drug orlistat the wrong choice for patients who are trying to lose weight.
• Big Pharma Sinks to Bottom of Barrel in Public Opinion Poll
  (November 2019)
  In his editor’s column, Dr. Michael Carome reviews the results of a recent Gallup poll showing that Americans now view the pharmaceutical industry more negatively than any other major industry in the U.S.
• Medications That Cause Hearing Problems
  (November 2019)
  For most people with hearing loss, the condition likely is age-related or due to long-term exposure to loud noise. But for some patients, the cause of the problem can be found in the medicine cabinet.
• Most Preventive Antibiotics Before Dental Procedures Are Unnecessary, Study Finds
  (November 2019)
  Dentists often prescribe antibiotics before dental procedures as prophylaxis to prevent infection from the release of bacteria from the mouth into the bloodstream. Find out which patients should receive such preventive antibiotics before dental procedures.
• New Guideline Recommends Against Thyroid Hormone Treatment for Most Adults With Mildly Underactive Thyroid
  (November 2019)
  In this article, we describe a common condition known as subclinical hypothyroidism and discuss the newest guidelines regarding which patients with this condition should be treated with thyroid hormone replacement.
• News Brief: FDA Announces Discovery of Cancer-Causing Contaminant in Heartburn Medication
  (November 2019)
  In this month’s news brief, we report actions taken by the FDA and regulators in other countries in response to the discovery of a probable human carcinogen in a widely used medication that suppresses stomach acid.

  View the entire October 2019 issue in PDF format

• How to Dispose of Unused Opioids and Other High-Risk Drugs Safely
  (October 2019)
  Unused, unneeded or expired drugs in homes present a number of risks, including intentional or accidental overdose in humans (particularly young children). Learn how to safely dispose of these drugs.
• Revolving Door to FDA Commissioner’s Office Sows Distrust in Agency
  (October 2019)
  In his editor’s column, Dr. Michael Carome discusses how FDA Commissioner Scott Gottlieb’s resumption of close ties to the pharmaceutical industry following his resignation from the agency created a cloud of justifiable distrust about actions taken by the FDA under his leadership.
• An Update on Drug-Induced Parkinsonism
  (October 2019)
  Next to Parkinson’s disease, drug-induced parkinsonism is the second most common cause of parkinsonism, accounting for about 8-12% of all parkinsonism cases. Find out which commonly used drugs can cause this condition.
• Recent FDA Safety Warnings About Drugs for Insomnia, Dietary Supplements
  (October 2019)
  The FDA recently issued two important safety alerts for doctors and patients. The first alert described risks of serious, often fatal injuries linked to use of the three so-called “Z-drugs” for insomnia. The second warned women of childbearing age not to use vinpocetine, an ingredient found in many widely available dietary supplements.
• Foreign Regulators Issue Warnings About Wakefulness Drugs Modafinil (PROVIGIL) and Armodafinil (NUVIGIL)
  (October 2019)
  This article discusses important warnings issued by drug regulators in Canada and Ireland about new evidence of an increased risk of congenital birth defects associated with use of the stimulant drugs modafinil and armodafinil.
• News Brief: Federal Researchers Link Kratom to 91 Unintentional Overdose Deaths
  (October 2019)
  In this month’s news brief, we report new data from the Centers for Disease Control and Prevention regarding the public health risks posed by kratom and kratom-containing dietary supplements, which have been falsely touted by some marketers as safe treatments for a variety of conditions, including anxiety, depression, opioid use disorder and pain.

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• Letter to the FDA Calling for Investigation Into an Apparent Illegal Clinical Trial That Tested Unapproved Naltrexone Implants in Prison Inmates (HRG Publication #2499) (November 20, 2019)
  Public Citizen and 31 doctors, bioethicists, prisoner advocates, and academics called on the FDA to immediately investigate BioCorRx, Inc. & the Louisiana Department of Public Safety and Corrections’ testing of an unapproved sustained-release naltrexone implant on prison inmates to determine its effectiveness in managing addiction disorders. Although the FDA has approved naltrexone in oral tablet & injectable forms to treat alcohol & opioid dependence, it has never approved any surgically implanted form.
• Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Using Empagliflozin to Treat Patients with Type 1 Diabetes (HRG Publication #2498) (November 13, 2019)
  In testimony before the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the FDA to reject Boehringer Ingelheim’s supplemental new drug application for empagliflozin for treatment of type 1 diabetes because the drug offers minimal benefits that do not outweigh the significantly increased risk of life-threatening diabetic ketoacidosis.
• Petition to the DEA and FDA to Reschedule the Opioid Tramadol From Schedule IV to Schedule II (HRG Publication #2497) (November 6, 2019)
  Public Citizen petitioned the Drug Enforcement Administration and Food and Drug Administration (FDA) to reschedule the opioid tramadol from the weakly controlled schedule IV under the Controlled Substances Act to the more tightly controlled schedule II because it is overprescribed, often misused, highly addictive and potentially deadly.
• Comments on the FDA’s Proposal to Exclude Nine Drugs From the 503B Bulks List for Pharmacy Compounding by Outsourced Facilities (HRG Publication #2496) (November 4, 2019)
  We strongly support the FDA’s proposal to exclude nine bulk drug substances from the list of bulk drug substances for which there is a clinical need for pharmacy compounding by outsourcing facilities. Each of the nominated bulk drug substances is a component of one or more FDA-approved drug products, and the nominators have failed to demonstrate that there is a clinical need for outsourcing facilities to compound drug products using the nominated bulk drug substances.
• Petition to the FDA to Ban the Drug Hydroxyprogesterone Caproate (Makena), Approved for Prevention of Preterm Birth (HRG Publication #2493) (November 1, 2019)
  Public Citizen petitioned the FDA to immediately withdraw approval of the widely prescribed drug hydroxyprogesterone caproate (Makena) and to place this drug on the list of drug products that may not be used in pharmacy compounding. These actions were requested because the results of a recently completed post-market clinical trial showed that it is not effective for preventing preterm birth prior to 35 weeks of pregnancy or major fetal and neonatal complications related to preterm birth.