Many Medical Devices Hit the Market before Safety Studies Are Published
(Reuters Health)—Medical devices approved by the U.S. Food and Drug Administration (FDA) are often cleared before studies on their safety or effectiveness have been released to the public, a report...
View ArticlePatients with OA Respond to Low-Dose SoluMatrix Meloxicam; Off-Label Use of...
In a clinical trial, patients with osteoarthritis taking low-dose SoluMatrix meloxicam used less rescue medication to manage pain. Also, the FDA has issued a new warning against using oral ketoconazole...
View ArticleU.S. Judge Cuts $500 Million Verdict over Johnson & Johnson Hip Implants
NEW YORK (Reuters)—A U.S. judge has slashed a $500 million verdict against Johnson and Johnson and its DePuy unit over allegedly defective metal-on-metal Pinnacle hip implants to approximately $151...
View ArticlePrescription-Drug Monitoring Saves Lives, Could Save More
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds....
View ArticleRheumatology Drug Updates: Labeling for Fluoroquinolones; FDA to Review...
FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The...
View ArticleNew FDA Warnings: Patients on SGLT2 Inhibitors at Risk of Acute Kidney Injury...
The FDA is strengthening its warning that canagliflozin and dapagliflozin may increase the risk for acute kidney injury in some patients. Also, the FDA has issued a warning that patients should not...
View ArticleFDA Approves New Drugs for Pain
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is...
View ArticleEMA Flags Faulty Generic Drug Data, Backs Sales Halt
(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was...
View ArticleNew FDA Warnings: Patients on SGLT2 Inhibitors at Risk of Acute Kidney Injury...
The FDA is strengthening its warning that canagliflozin and dapagliflozin may increase the risk for acute kidney injury in some patients. Also, the FDA has issued a warning that patients should not...
View ArticleFDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug...
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication...
View ArticleHeparin Fails to Prevent Leg, Lung Clots After Arthroscopy, Casting
NEW YORK (Reuters Health)—Low-molecular-weight heparin failed to prevent symptomatic venous thromboemboli in people receiving knee arthroscopy or a lower leg cast, according to a pair of studies...
View ArticleCelecoxib & Cardiovascular Death: NSAID Safety Under Review
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen...
View ArticleRheumatology Drug Updates: Celecoxib and Cardiovascular Safety Trial Results...
Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor...
View ArticleInsights into Drug-Related Interactions in Older Adults
A study showed that prior hospitalization and the use of multiple medications are risk factors for drug and drug–disease interactions...
View ArticleACR Releases New Position Statements on Site of Service & Compounding
Patient Safety & Site of Service for Biologics Although emphasizing its strong support for the use of biologic agents as necessary treatments for rheumatic diseases, the ACR Board of Directors...
View ArticleAs Biosimilars Hit, EU Pharma Warns against Blanket Prescribing
(Reuters)—European drugmakers, faced with increasing competition from cut-price copies of complex biotech drugs, cautioned doctors on Thursday to take care when switching patients from an established...
View ArticleFDA Drug Labeling, Approval Process Help Minimize Lawsuits Against...
Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the...
View ArticleRheumatologists Respond to Prescription Opioid Analgesic Crisis
The alarming statistics on prescription opioid overdoses are well known to medical professionals, thanks to the Centers for Disease Control and Prevention (CDC)’s widely cited finding that deaths from...
View ArticleDEA Proposes Cutting Production of Come Opioids
(Reuters)—The U.S. Drug Enforcement Administration (DEA) on Friday proposed a 20% reduction in the manufacture of certain commonly prescribed opioid painkillers, as well as other controlled substances...
View ArticleFlimsy Evidence Behind Many FDA Approvals
(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical...
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