The FDA is recommending pregnant women avoid using NSAIDs as early as week 20 of pregnancy due to the risk of kidney problems in a developing fetus.
FDA Updates Boxed Warning of Benzodiazepines, Adding Risks for Abuse & Addiction
The FDA is requiring all benzodiazepines to carry an updated boxed warning that addresses the risks of misuse, abuse and addiction associated with their use.
Safety Risk with Higher Dose Tofacitnib
According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…
Second Biosimilar Equivalent to Adalimumab
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…
FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…
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…
FDA Warns Makers of Superbug-Prone Scopes over Testing Violations
(Reuters)—Manufacturers of duodenoscopes linked to recent superbug outbreaks at U.S. hospitals skirted a host of testing, manufacturing and reporting requirements, the U.S. Food and Drug Administration said in warning letters to the companies released on Monday. The letters, sent on Aug. 12, cite Olympus Corp Pentax Medical and Fujifilm Holdings Corp with multiple violations found…
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)…