Safety & Recalls

The FDA has issued a final guidance for beta-lactam oral antibiotic suspension products, including amoxicillin.

This is second issue related to Omnipod. Last week, the company announced that it had received 50 complaints related to the batteries of Omnipod DASH Personal Diabetes Manager.

Vizient saw a 43% surge in demand for all amoxicillin products in the acute care setting from September to October, but fill rates have dropped 25%.

Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage.

The regulatory agency has added the risk of rare skin infections to the warnings and precautions section of the labeling for amoxicillin products.

Several suppliers of the widely-used antibiotic have limited or no availability of some formulations.

Findings by researchers at Epic, the electronic health record company, show that the benefits extend to people ages 50-64.

Administration of a solution containing glass could lead to irritation or swelling, vasculitis/phlebitis, allergic reactions, and pulmonary embolism.

The recall was triggered by the presence of nitrosamine above the proposed limit.

Two reports show that drug-related deaths are skyrocketing among people 65 years and older.

Exela has received five reports of flying glass injuring skin, eye and/or other parts. The recall includes both Exela and Civica brands.

Until supply is restored, the FDA suggests the use of alternatives such as the extended-release version of amphetamine mixed salts.

In one lot, a bottle containing clopidogrel was mislabeled as atenolol. This lot was sold to AmerisourceBergen and McKesson.

Dark red, brown and black particulates were seen inside of one vial. Acyclovir is used to treat genital herpes and shingles.

Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.

Labor shortages and Drug Enforcement Agency quotas have led to supply shortages of Adderall and its generics, which are used to treat attention deficit hyperactivity disorder.

This recall of propofol because of particulates seen in vials follows a previous one in July 2022.

Genentech has updated the warnings section of the label for the MS therapy Ocrevus to include information about cases of immune-mediated colitis and a serious brain infection in the post-marketing setting.

Kelly Stanton, director of quality at Qualio, talks about the impact on patients of prescription drug recalls.

This follows a move by Bayer to import Ultravist with non-U.S. labeling also to address pandemic-related shortages of iodine-containing contrast media used in imaging procedures.

BMS warns about the risk of extramedullary hematopoiesis, a rare complication in which the production of blood cells occurs outside of the bone marrow.

Particulates were seen in a single vial, which could lead to blockage of blood vessels, including decreased blood flow to the brain, heart attack, and pulmonary embolus.

This is the second batch to be recalled because of the potential of missing labels.

Final results from a phase 3 study found that Copiktra was associated with a higher risk of serious side effects, dose modifications, and deaths compared with Kesimpta.

Labels now warn that buprenorphine products that dissolve in the mouth can cause dental problems. Buprenorphine is used to treat opioid use disorder and pain.

Byetta is used to control blood sugar in patients with diabetes. A new warning includes the risk of gallstones and gallbladder inflammation.

The recalls were made because the medications failed sterility testing.

The label now includes a new section about the risk of substituting an oral azacitidine product, Onureg, for the injection therapy.

The impacted lot failed a dissolution test, meaning it was taking longer to dissolve once ingested. This can result in less anagrelide available in the body, possibly leading to clotting or bleeding events such as a heart attack or stroke.

The FDA has changed how often AcelRx Pharmaceuticals is required to audit healthcare settings that administer Dsuvia, which is a synthetic opioid.