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…
FDA Strengthens Warning Label for Certain Antiinflammatory Drugs
(Reuters)—The U.S. Food and Drug Administration is strengthening an existing warning label that non-aspirin, non-steroidal antiinflammatory drugs (NSAIDs) increase the risk of heart attack or stroke. NSAIDs include ibuprofen, naproxen, diclofenac and celecoxib, all of which carry FDA warning labels. The agency said it would require updates to the labels of prescription and over-the-counter (OTC)…
Second Indian Firm Under Fire for Shoddy Clinical Drug Trials
LONDON/MUMBAI (Reuters)—Another Indian clinical research organization, Quest Life Sciences of Chennai, is in trouble over defective trials work, according to a warning issued by the World Health Organization. The action by the United Nations health agency follows an earlier scandal over drug testing at GVK Biosciences, which resulted in approvals for hundreds of generic drugs…
Public Rarely Knows Why FDA Rejects New Drugs
(Reuters Health)—Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete…
U.S. NIH Drug Facility Suspended after Contamination Found
(Reuters)—The National Institutes of Health said on Thursday it had suspended operations of a facility that makes products used for clinical research after the discovery of fungal contamination in two vials of albumin. Vials made from the same batch of albumin had been administered to six patients, though it is not known if those were…
Rheumatology Drug Updates, Trials, Safety Data
Information on acetaminophen restrictions; trials for clazakizumab, epratuzumab, romosozumab; and drug safety updates rheumatologists need to know
Rheumatologists Struggle with Drug Shortages
While not yet at a ‘catastrophic’ level, shortages are becoming more common
The Law of Unintended Consequences Rears Its Head
A program to improve drug safety has increased drug prices for patients with gout and FMF
Pisetsky’s Rules vs. the Peltzman Effect
Pondering drug safety
Unsafe at Any Dose?
Physicians must remember that all drugs have safety risks