Recent Postings

Recently published research demonstrated that bisphosphonate drugs are useful for preventing osteoporosis-related hip fractures, but that continuous bisphosphonate therapy beyond five years appears to offer no additional benefit for preventing such fractures.

According to a troubling report issued in January by the Government Accountability Office — an independent, nonpartisan federal watchdog agency that works for Congress — the COVID-19 pandemic has caused severe reductions in the FDA’s entire inspection program, with inspections of foreign drugmakers brought to a virtual standstill.

Patients taking the commonly prescribed drug atorvastatin, which is a member of the statin family of cholesterol-lowering drugs, should be aware that it has clinically important interactions with many other prescription medications.

Soon after the coronavirus pandemic began, theoretical concerns were raised about the possibility that the widely prescribed angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) may increase the risk of contracting the coronavirus and predispose COVID-19 patients to more severe illness. Results of a randomized controlled trial provide new evidence that ACE inhibitors and ARBs can be safely continued in patients hospitalized with COVID-19.

Idarucizumab (PRAXBIND) received accelerated approval from the FDA in 2015 for reversal of the effect of the new oral anticoagulant (blood thinner) dabigatran (PRADAXA) when needed before emergency surgery or urgent procedures or in life-threating or uncontrolled bleeding. Learn why we have designated idarucizumab and dabigatran as Do Not Use.

In this month’s Question & Answer feature, we respond to a reader’s question about whether we had any new information regarding the risks of allergic reactions in recipients for the two-dose Pfizer-BioNTech and Moderna messenger RNA COVID-19 vaccines.

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 omeprazole (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.