Safety & Recalls

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

The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.

Apokyn and Kynmobi contain apomorphine hydrochloride, which can cause hemolytic anemia that requires hospitalization. The products both treat the loss of muscle movement control caused by Parkinson’s disease.

Some children who received GnRH agonists for precocious puberty have experienced a serious side effect known as idiopathic intracranial hypertension, which results in elevated spinal fluid pressure in the brain.

The production suspension will impact both the commercial and clinical trial supplies of Lutathera and Pluvicto in the United States and Canada.

The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.

Higher than normal levels of nitrosamine have been detected. Long-term exposure to high amounts of nitrosamine can lead to cancer.

Zosyn’s label was updated to warn about the risk of a severe immune response called hemophagocytic lymphohistiocytosis.

The label of Triumeq now includes additional information about use in patients who have both HIV and hepatitis B.

Some vials have been found to be missing a label.

Two new subsections have been added to the warning and precautious section of Zepzelca’s label to address serious adverse events that were identified during post-market monitoring.

The recall was related to syringes in these lots malfunctioning.

The recall of orphenadrine was due to the presence of the cancer-causing nitrosomine.

The recall of Accuretic and generics distributed by Greenstone is a result of the presence of a cancer-causing agent.

The lots could contain trace amounts of sodium, silicon, chromium, aluminum, and cellulose, which could result in irritation or infection and has the potential to block blood vessels in the heart, lungs, or brain.

B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.

A total of 28 lots have been recalled because of a high rate of allergic reactions.

Over time, Egaten, an antiparasitic, can increase the QTc interval, resulting in a heart rhythm condition that can cause chaotic heartbeats.

The CDC released the first real world data February 15 in a Morbidity and Mortality Weekly Report (MMWR) that infants younger than 6 months were overall 61% less likely to be hospitalized from COVID-19 if their mothers were vaccinated during pregnancy through completion of a 2-dose primary mRNA COVID-19 vaccine series with either Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax).

Problems with N-nitrosodimethylamine (NDMA)-contaminated metformin were identified by the FDA in 2020. Viona Pharmaceuticals announced in earlier this month that it was recalling 23 lots of the popular diabetes medication.

Smaller doses are recommended for people with moderate renal impairment and the treatment should not be taken by people with serious kidney disease. There are also drug interactions to be aware of because Paxlovid is an inhibitor of CYP3A.

Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.

This is the Areva's second importation of bupivacaine this year.

Because of a COVID-19 related shortage, facilities may not have immediate access to Actemra, which is required as part of the REMS programs for CAR T-cell therapies.

Medexus is working with Ethypharm to generate the data needed to support an abbreviated new drug application for triamcinolone hexacetonide.

The topical anesthetic was found to be “super potent,” which could lead to systemic toxicity and central nervous system and cardiovascular reactions.

The new boxed warning for Xeljanz, Olumiant, and Rinvoq includes the risk of cardiovascular adverse events and cancer.

Glass has been detected in the two lots of Veklury, which is used to treat patients who are hospitalized with COVID-19.

A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.