Safety & Recalls

New requirements resulted in long call wait times, which has led to patient access issues.

The incidence of brain swelling was highest in the group of patients who received the highest doses of Aduhelm, as well as the group of patients who are carriers of the APoE gene.

The antiseizure medication affected by the recall could have sterility issues.

Equipment and process issues could lead to a lack of sterility.

The safety labeling for the beta interferons that are used to treat multiple sclerosis have been updated to include warnings about injection site reactions.

The studies conducted to support Verzenio’s most recent approval for the treatment of high-risk early breast cancer provided additional safety data.

The label now includes new data from the trial that supported Cyltezo’s application for interchangeability with Humira.

Glass was found in one vial of Cubicin, which treats patients with Staph infections of the skin and blood.

The product contained N-nitrosoirbesartan impurity, a probable human carcinogen.

Hikma, which makes the broad-spectrum antibiotic, has experienced manufacturing delays.

The labeling of Trikafta, which treats cystic fibrosis, has been updated to warn about the possibility of liver failure that could lead to the need for transplantation.

The labeling for selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs) now must include information about sexual side effects in the warning and precautions and patient counseling sections.

The diabetes therapy is being recalled because of a lack of potency.

To date, Pfizer has not received reports of adverse events related to this recall, but is making the move as a precaution.

The affected lots of this rare disease therapy have been contaminated with yeast, mold, and bacteria, which could lead to life-threatening infections.

The lot contains kits with the incorrect solution for diluting vancomycin, which could lead to doses above or below recommended levels.

The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.

The product is considered “super potent” with a higher dose that could result in serious cardiac toxicities.