Medwatch

Therapeutic antibodies designed to target immune checkpoint proteins such as PD-1, PD-L1, and CTLA-4 have been applied in the treatment of various tumor types, including small and non-small cell lung cancers, melanoma, renal cell carcinoma, and others. These treatments combat cancers by reactivating CD8 cytotoxic T-cells. Nevertheless, this unique targeted mode of action was found to be associated with a broader range of immune-related adverse events, irAEs, affecting multiple physiological systems. Depending on their severity, these irAEs often necessitate the suspension or discontinuation of treatment and, in rare instances, may lead to fatal consequences...

PRCIS: Glucosamine supplementation is common but can be associated with increased intraocular pressure (IOP) and could contribute to the pathogenesis of glaucoma. It may be prudent for ophthalmologists to elicit any history of glucosamine use from their patients and advise them accordingly. Further studies on the role of glucosamine in glaucoma are warranted. BACKGROUND: The most frequently recommended slow-acting medication for osteoarthritis symptoms is glucosamine, although its effectiveness is questionable...

Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices' design and efficiency profile and avoid device-related complications and associated failures...

Drug-induced liver injury (DILI) is one of the leading causes of death from acute liver failure (ALF) in the United States, accounting for approximately 13% of ALF cases in the United States. Selective androgen receptor modulators (SARMs) were first developed to increase muscle mass while avoiding the side effects of conventional androgenic steroids. Although not Food and Drug Administration (FDA) approved, they are widely available online and are consumed to enhance athletic performance. We report a 22-year-old, previously healthy male, who presented with a two-week history of worsening jaundice, nausea, fatigue, pruritus, dark urine, and light stools...

BACKGROUND: The Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS) is a post-marketing surveillance system which relies on spontaneous reports of adverse drug reactions (ADRs). Our objective was to evaluate how black box warning (BBW) updates impact ADR reporting rates. RESEARCH DESIGN AND METHODS: We searched MEDWATCH for all BBW updates issued between January 2014 and December 2016 and categorized them as new, major, and minor. Rates of relevant ADR reports from the FAERS database in the 4 years preceding and following a BBW update were assessed among the different BBW categories...

The Food and Drug Administration (FDA) is warning that an increased risk of death is possible with the use of duvelisib (Copiktra) compared with the monoclonal antibody ofatumumab in the treatment of chronic lymphocytic leukemia. Serious adverse effects also appear to be more likely with duvelisib use.Nurses should monitor for adverse effects and report them to the FDA's MedWatch program.

PURPOSE: Spontaneous notification systems are essential in a post-marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified. To overcome this sub-notification problem, new methods need to be developed to improve and facilitate reporting. In this sense, the use of digital media, mainly medical mobile apps, has been presented as a powerful tool, including in pharmacovigilance. We performed a scope review to identify the available apps used to report adverse drug reactions around the world to eventually identify which of them best fits the Portuguese pharmacovigilance system...

PURPOSE: The following case report discusses probable clitoral priapism secondary to duloxetine and pregabalin. While this is a rare adverse effect, it is possible given the mechanism of action and potentiating effects of the combined therapy. This adverse drug reaction was reported to MedWatch and shows that additional research into the physiology of clitoral erection is warranted given the scarcity of information on how drugs influence this reaction. SUMMARY: A 53-year-old African American female with uncontrolled anxiety was started on duloxetine...

Melatonin is an endogenous neurohormone that regulates the sleep-wake cycle (1). It is used therapeutically for insomnia in adults and for primary sleep disorders in children (2). Melatonin is regulated by the Food and Drug Administration (FDA) as a dietary supplement. Various synthetic melatonin preparations are widely available over the counter (OTC) in the United States with sales increasing from $285 million in 2016 to $821 million in 2020 (3). Children are at increased risk for melatonin exposure because of the supplement's widespread use and growing popularity as a sleep aid...

Initial clinical trial data for umbralisib (Ukoniq), a drug currently approved to treat relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma, indicate that umbralisib may increase the risk of death or serious adverse effects when given with a specific monoclonal antibody to treat chronic lymphocytic leukemia.Patients receiving umbralisib to treat lymphomas should be evaluated closely for adverse effects. Nurses and other health care providers should report any of these adverse effects to the Food and Drug Administration's MedWatch program...

The growing prevalence of obesity in the USA has resulted in increased consumption of weight loss products that promote fat metabolism. Dietary supplements used for weight loss contain a wide variety of ingredients but the amount of scientific information available on these ingredients varies considerably. Such supplements have documented and undocumented adverse effects. Although the FDA frequently issues health advisories, the health consequences of consuming supplements are often overlooked by the general public...

The Food and Drug Administration (FDA) has issued a safety communication to warn the public and health care professionals not to use needle-free devices for injection of dermal fillers. These devices are not approved by the FDA. FDA-approved dermal fillers are for prescription use only with a syringe and either a needle or cannula.Nurses should inform patients not to purchase any needle-free devices or products over the internet. Adverse effects from these devices should be reported to the FDA's MedWatch system...

Various herbal medicines have been used around the world for more than 5,000 years. Herbal medicines, or herbal supplements, are defined as any products originating from plants and used to preserve or recover health. In the United States, the popularity of herbal supplements has increased in the last several decades. Many physicians do not ask patients about herbal supplement use, and one-third of patients do not inform their physician about supplement use. However, physicians should ask, because although many supplements are considered low risk and safe, some have significant risks of adverse effects...

PURPOSE: To provide an overview of compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and to describe the pharmacist's role within the US Food and Drug Administration's (FDA's) Compounding Incidents Program, whose efforts are aimed at protecting the public against poor-quality compounded drugs through surveillance, review and response to adverse events and complaints. SUMMARY: Compounded drugs may serve an important medical need for patients who cannot be treated with medications approved by FDA; however, compounded drugs are not approved by FDA and are not subject to premarket review for safety, efficacy, or manufacturing quality; thus, they may pose safety risks to patients...

Statins are a class of lipid-lowering medications that reduce illness and mortality in those who are at a high risk of developing cardiovascular disease. They are the most common cholesterol-lowering drugs. A case control study published in 2002 indicated that statins may increase the risk of peripheral neuropathy. Statin users were 14-fold more likely to develop peripheral neuropathy than non-users, although the overall risk of developing neuropathy was minimal. However, a number of other studies have produced conflicting results regarding neuropathy and statins...

The pervasive use of counterfeit sexual enhancement supplements is increasing worldwide. There are thousands of vendors on the internet while local gas stations and convenience stores are selling it across the United States (US). We report a case of right coronary artery ST-segment elevation and complete heart block in a nitrate-free patient shortly after consuming three 950 mg pills of a sexual enhancer known as rhino and completing sexual intercourse. Coronary angiography revealed 100% occlusion of the right coronary artery and a drug-eluting stent was inserted with a transvenous pacer that he tolerated well, and recovered without complications...

ABSTRACT: Objective: NeuroStar® Advanced Therapy System is a transcranial magnetic stimulation (TMS) device with FDA-clearance for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. With TMS, magnetic pulses are transmitted into the brain. Though the exact mechanism of action is unknown, it is postulated that resulting neuronal depolarization and changes in brain functional activity may be associated with various physiologic changes that lead to relief of depression in the indicated population...

No abstract text is available yet for this article.

Introduction : Attention-deficit/hyperactivity disorder (ADHD) commonly occurs in children, adolescents, and adults. Although symptoms of ADHD often respond robustly to treatment with stimulants (amphetamine or methylphenidate), not all patients are appropriate candidates for treatment with these drugs. Guanfacine extended-release (GXR) is a non-stimulant alternative drug approved for the treatment of ADHD in the United States (U.S.), Canada, and Europe. Areas covered : The chemistry, pharmacokinetics, mechanism of action and dosage of GXR are presented...

BACKGROUND: Neuroinflammation has been implicated in depression. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been found effective in treating animal models of depression, alone or with antidepressant drugs. However, results with NSAIDs have been mixed in human observational studies, with both better and worse depression outcomes reported. In the current study, we evaluated the effect of NSAIDs on suicidal ideation and depression. METHODS: We used data from MedWatch, the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program...