In his editor’s column, Dr. Michael Carome discusses a troubling report that detailed how drugmaker Merck & Co. and the FDA failed to add a warning about the potential risk of suicidal thoughts in men taking the company’s anti-baldness drug PROPECIA to the drug’s U.S. product labeling.
In September 2020, the FDA announced that it would require the manufacturers of all benzodiazepines to update the black-box warning (the strongest warning that the agency can require) for these drugs to describe risks of abuse, addiction and other related adverse reactions. Such action was long overdue.
In this article, we review results of new research that examined a specific form of nondrug psychological therapy, referred to as cognitive behavioral therapy for insomnia, for management of chronic insomnia in patients with other major physical or mental disorders.
Neuroleptic malignant syndrome is a life-threatening neurological disorder most often caused by neuroleptic (antipsychotic) medications, which are used to treat schizophrenia and certain other psychiatric disorders, among other things. The syndrome also can be caused by certain other drugs used to treat nausea and depression, as well as by the sudden discontinuation of a dopamine agonist (drugs that are used most commonly to treat Parkinson’s disease).
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).