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

  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.

  View the entire September 2019 issue in PDF format

• Antibiotics Not Always Necessary for Acute COPD Exacerbations
  (September 2019)
  Doctors often prescribe antibiotics to treat acute exacerbations of chronic obstructive pulmonary disease (COPD), which are characterized by increased shortness of breath, cough, sputum production and wheezing. But for some patients, the risks of such antibiotic treatment outweigh the benefits.
• FDA Sued for Dangerous Delay on Petition Seeking Stronger Drug Warnings
  (September 2019)
  In his editor’s column, Dr. Michael Carome discusses Public Citizen’s most recent legal maneuver to force the FDA to respond to our June 2016 petition seeking stronger warnings about the risk of compulsive or uncontrollable behaviors in the product labeling for a class of drugs known as dopamine agonists.
• Oral Itraconazole and Terbinafine: Too Dangerous for Fungal Nail Infections
  (September 2019)
  Fungal infections of the toenails and fingernails, a condition known as onychomycosis, are common. Learn why you should never take oral itraconazole or terbinafine to treat these cosmetic, non-health-threatening nail infections.
• Important Drug Interactions for the Seizure Drug Phenytoin
  (September 2019)
  Patients taking the commonly prescribed epilepsy drug phenytoin (DILANTIN, PHENYTEK), one of the oldest epilepsy drugs, should be aware that it has clinically impor¬tant interactions with many other prescription and over-the-counter medications. Some of these interactions can lead to phenytoin toxicity, and others can lead to ineffective seizure control.
• An Updated Look at the Treatments for Rosacea
  (September 2019)
  Rosacea is a chronic skin condition affecting 13 million Americans. Find out steps to take to prevent symptom flare-ups and learn which topical drug therapies are most effective and safest for treating this condition.

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• 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.
• Testimony Before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee Regarding Hydroxyprogesterone Caproate (Makena) (HRG Publication #2494) (November 1, 2019)
  In a testimony before the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA withdraw hydroxyprogesterone caproate (Makena) from the market because there is a lack of substantial evidence demonstrating that the drug is effective for preventing preterm birth or complications of preterm birth.
• Testimony Before the FDA’s Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding Montelukast (HRG Publication #2492) (September 27, 2019)
  In testimony before a joint meeting of the FDA’s Pediatric Advisory Committee and Drug Safety and Risk Management Committee, Public Citizen urged the committees to recommend that the FDA strengthen warnings and alert healthcare providers about the use of montelukast for the treatment of asthma and the risk of neuropsychiatric events because this risk is inadequately communicated by healthcare providers/prescribers and patients remain unaware of the risk of these adverse events.