September 28th 2023
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
September 26th 2023
In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
September 11th 2023
Crystal formation could lead under- or over-dosing of Sandimmune oral solution, which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.
August 31st 2023
The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Digoxin is used to treat patients with heart failure and chronic atrial fibrillation.
August 2nd 2023
The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries, as well as possible solutions stakeholders can put into action.
FDA Pauses Clozapine REMS Program
New requirements resulted in long call wait times, which has led to patient access issues.
Large Study Finds Aduhelm Can be Associated with Brain Swelling
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.
Sagent Recalls Four Lots of Levetiracetam
The antiseizure medication affected by the recall could have sterility issues.
Formulary Watch Drug Shortage Update — November 21, 2021
SterRx Recalls 240 Lots of 12 Products
Equipment and process issues could lead to a lack of sterility.
Formulary Watch Drug Shortage Update — November 14, 2021
FDA Updates Warning Labels for MS Products
The safety labeling for the beta interferons that are used to treat multiple sclerosis have been updated to include warnings about injection site reactions.
Lilly Updates Safety Labeling for the Anticancer Therapy Verzenio
The studies conducted to support Verzenio’s most recent approval for the treatment of high-risk early breast cancer provided additional safety data.
Formulary Watch Drug Shortages Update — November 7, 2021
Formulary Watch Drug Shortages Update — October 31, 2021
Boehringer Ingelheim Updates Safety Labeling of Cyltezo
The label now includes new data from the trial that supported Cyltezo’s application for interchangeability with Humira.
Formulary Watch Drug Shortages Update — October 24, 2021
Merck Recalls One Lot of Cubicin
Glass was found in one vial of Cubicin, which treats patients with Staph infections of the skin and blood.
Formulary Watch Drug Shortages Update — October 17, 2021
Lupin Recalls All Lots of Irbesartan Tablets and Irbesartan/Hydrochlorothiazide Tablets
The product contained N-nitrosoirbesartan impurity, a probable human carcinogen.
FDA Allows Importation from Canada of Cefotaxime
Hikma, which makes the broad-spectrum antibiotic, has experienced manufacturing delays.
Drug Shortages Update — October 10, 2021
Vertex Updates Warnings Section of Trikafta Label
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.
FDA Requires New Labeling for Antidepressants
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.
Formulary Watch Drug Shortages — October 3, 2021
Lilly Recalls One Lot of Glucagon
The diabetes therapy is being recalled because of a lack of potency.
Drug Shortages Update — September 26, 2021
Formulary Watch Drug Shortage Tracker — September 19, 2021
Pfizer Recalls All Lots of Smoking Cessation Drug Chantix
To date, Pfizer has not received reports of adverse events related to this recall, but is making the move as a precaution.
FDA Recalls Three Lots of Ruzurgi
The affected lots of this rare disease therapy have been contaminated with yeast, mold, and bacteria, which could lead to life-threatening infections.
Drug Shortages — September 12, 2021
FDA is Recalling One Lot of Firvanq
The lot contains kits with the incorrect solution for diluting vancomycin, which could lead to doses above or below recommended levels.
Drug Shortages Update — September 5, 2021
FDA’s New Warning Includes Xeljanz and other JAK Inhibitors
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.
Teligent Recalls One Lot of Lidocaine
The product is considered “super potent” with a higher dose that could result in serious cardiac toxicities.
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