Safety & Recalls

Other indications for the blockbuster cancer mediation are not affected.

Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”

The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.

Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.

Shigella cause an estimated 450,000 infections in the United States each year and an estimated $93 million in direct medical costs.

Brimonidine tartrate ophthalmic solution is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Patients who have had liver problems in the past may be at risk of liver damage from Sprycel, which is used to treat patients with chronic myeloid leukemia.

Hospira/Pfizer’s potassium phosphates product alone may produce daily aluminum exposures of up to twice of the FDA-recommended limit for children.

The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis.

IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.

Dosing has been lowered to reduce the risk of liver damage in patients taking Turalio, which is approved to treat patients with a rare tumor that affects the joints.

Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.

Hospira is calling one lot of vancomycin hydrochloride, an antibiotic to treat patients with serious infections caused by methicillin-resistant staphylococci.

Among the most-read product recall stories are those of amoxicillin, metformin, sodium bicarbonate Omnipod 5, and clopidogrel and atenolol.

Among the top safety stories this year are Genentech’s warning to Ocrevus label, FDA’s update to GnRH agonists, a study about JAK-inhibitor side effects, FDA’s warning about Prolia in kidney disease and safety issues related to the potential Alzheimer’s disease drug lecanemab.

Testing of the blood pressure medication revealed nitrosamine levels that were above acceptable limits.

Lilly’s first-in-class medicine that activates both the GLP-1 and GIP receptors, Mounjaro, is the latest to be included on the FDA’s drug shortages list because of high demand.

Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.

Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.

Adderall pills containing methamphetamine and oxycodone pills containing fentanyl have been among the fake pills the DEA and investigators have confiscated.

An FDA review has found that Prolia can result in low calcium levels in the blood in patients with advanced kidney disease and can lead to hospitalization and death.

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.