Recent Postings

In this article, we discuss key evidence supporting the conclusion that low-dose aspirin should not be used for the sole purpose of preventing any type of cancer, an indication for which the drug is not approved by the FDA.

In his editor’s column, Dr. Michael Carome applauds the U.S. Department of Health and Human Services Office of Inspector General (OIG) for issuing a “Special Fraud Alert” highlighting the “inherent risks” of illegal fraud associated with pharmaceutical and medical device com¬panies paying physicians and other health care professionals to speak at company-sponsored events.

Patients taking the commonly prescribed epilepsy drug carbamazepine (CARBATROL, EPITOL, EQUETRO, TEGRETOL, TERIL) should be aware that it has clinically important interactions with numerous other prescription and over-the-counter medications.

Gabapentin (NEURONTIN, HORIZANT, GRALISE) is frequently prescribed for uses not approved by the FDA (so-called off-label uses), especially for chronic pain. A recently published clinical trial of the drug for treatment of chronic pelvic pain in women underscores why such off-label use, which we oppose, should be avoided.

Learn why the FDA in October 2020 warned that pregnant women in general should avoid using nonsteroidal anti-inflammatory drugs (NSAIDs) at about 20 weeks or later in pregnancy because of the rare risks of pregnancy complications and serious harm to an unborn baby.

In this month’s Question & Answer feature, we respond to a reader’s question about whether the stomach-acid–suppressing drug esomeprazole (NEXIUM, NEXIUM 24HR, VIMOVO) has the same drug interactions as the closely related drug omepra¬zole (PRILOSEC, PRILOSEC OTC, ZEGERID).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.