(Reuters Health)—Doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids, a new study found. The launch of drug-monitoring programs in 24 states led to an immediate 30 percent drop in prescriptions for Schedule II opioids, the most addictive, in patients with pain complaints, the study showed….
Patients with OA Respond to Low-Dose SoluMatrix Meloxicam; Off-Label Use of Ketoconazole Results in Death
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 off label to treat onychomycosis and fungal skin infections…
FDA Restricts Use of Systemic Fluoroquinolones Due to Side Effects & Will Review Application of Apadaz for Pain
The FDA has issued new safety guidelines for systemic fluoroquinolones, restricting their use to patients with no alternative treatment options…
U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards
MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…
U.S. Sen. Markey Places Hold on Obama’s Nominee to Lead FDA
(Reuters)—U.S. Sen. Edward Markey (D-Mass.) said on Monday he has placed a hold on President Barack Obama’s nominee to head the U.S. Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee…
Adverse Events More Common with Off-Label Drug Use
NEW YORK (Reuters Health)—Adverse drug events (ADEs) are more common when drugs are used off label, especially when the off-label use lacks strong scientific evidence, researchers from Canada report. “Our study demonstrated that physicians need to be cautious in prescribing off-label when there is a lack of strong scientific evidence for the use of the…
U.S. Bans Another Indian Drug Plant over Production Quality
MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…
FDA Issues Stronger NSAIDs Warning
The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction…
Some Serious Drug Side Effects Not Reported to FDA Within 15 days
(Reuters Health)—Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds. Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths…
Most Rheumatologists Want FDA to Better Regulate Biosimilars
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…