March 2025 Drug Safety Part 2: New warnings for MRI contrast agents; Baqsimi, Belsomra, Furoscix, Iluvien ophthalmic, Metronidazole; Recalls of ADHD and acne meds; medication tips
(Jump to recalls announcements)
MRI Contrast Agents: Dotarem, Elucirem, Eovist, Gadavist, Multihance, Prohance, Omniscan
Warnings about the risk of acute respiratory distress syndrome (ARDS) and pulmonary edema (fluid in the lungs) were added to the labels of seven gadolinium-based contrast agents (GBCAs). These drugs are used as part of magnetic resonance imaging (MRI) procedures to provide enhanced image quality for diagnosis of conditions such as multiple sclerosis or cancer. Patients with acute respiratory distress syndrome (ARDS) require oxygen support and in some cases, mechanical ventilation. Cases of ARDS have occurred within less than 30 minutes to 24 hours after GBCA administration. Healthcare providers are advised to assess oxygen requirement and monitor for worsening respiratory function in patients experiencing breathing problems after administration of the GBCA.
Several other FDA warnings associated with GBCAs have been issued recently, including a July 2024 warning about the risk of acute pancreatitis and an expanded boxed warning in February 2024. Also, an FDA safety communication about risk of GBCAs being retained in the body was issued in 2018. Macrocyclic agents are often the first-choice type of contrast agent for both brain and full-body MRIs because of a better safety profile than the linear or first-generation types.
“Macrocyclic” GBCAs Latest Safety Labeling Updates for respiratory risk:
Dotarem (approved in 2013)
Elucirem (approved in 2022)
Prohance (approved in 1992)
“Linear” GBCAs Latest Safety Labeling Updates for respiratory risk:
Eovist (approved in 2008)
Gadavist (approved in 2011)
Multihance (approved in 2004)
First Generation GBCA
Omniscan (approved in 1993)
Omniscan is an older generation type of GBCA agent and has a poorer safety profile than the macrocylic and linear contrast agents. It is linked to nephrogenic systemic fibrosis (a serious disease of the skin and organs) in patients with kidney disease. The FDA issued a safety communication about the risk of nephrogenic systemic fibrosis in 2010.
Baqsimi (glucagon) intranasal powder
Baqsimi is a single-use intranasal dispenser that delivers glucagon to treat very low blood sugar (severe hypoglycemia) in adults and children with diabetes. The label was updated in support of its expanded approval for pediatric patients age one year and older, based on the results of a clinical trial. Previously, it was only approved for age four and up. Adds warning about serious hypersensitivity reactions including hives, trouble swallowing, dizziness, cough, fast heartbeat, and facial swelling. Nose bleed and cough were added to the list of common side effects. Baqsimi (glucagon) was approved in 1960; this single-use formulation was approved in 2019.
Baqsimi FDA Safety Label Change
Belsomra (suvorexant)
Insomnia drug Belsomra label was updated to report results of a lactation study. The active ingredient suvorexant was found to be present in low concentrations in breast milk. About 82% of suvorexant taken by the mother was excreted in breast milk within 24 hours. Patients are advised to talk with their doctors about the best way to feed their babies while taking Belsomra. Belsomra was approved in 2014.
Belsomra FDA Safety Label Change
Check out Belsomra Patient Reviews at Ask a Patient website.
Furoscix (furosemide) subcutaneous injection
Furoscix is a diuretic for treating edema (water retention) in adult patients with chronic heart failure; it was also recently approved to treat edema in adult patients with chronic kidney disease. This safety update supports the recent approval for kidney disease patients.
The single-use “On-body Infusor” will deliver an 80 mg dose of furosemide (30 mg over the first hour followed by 12.5 mg per hour for the next four hours). Patients with severely reduced kidney function may require additional diuretic therapy. Also warns that in patients with liver disease like hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may lead to hepatic encephalopathy and coma. For these patients, electrolyte balance should be carefully monitored. Furosemide was approved in 1968, while the Furoscix formulation was approved in 2022.
Furoscix FDA Safety Label Change
Iluvien (fluocinolone acetonide) ophthalmic implant
Iluvien is a corticosteroid that is implanted in the eye to treat diabetic macular edema (swelling in the central part of the eye that occurs as a result of inadequately treated diabetes). It recently received expanded approval to treat chronic non-infectious uveitis, an inflammatory eye disease that can cause irreversible vision loss if left untreated. The label warns that for non-infectious uveitis, hypotony (low eye pressure) has been observed within 24 hours of injection and has resolved within 2 weeks. Warns that patients may experience temporary blurred vision after the injection of the implant. See label for complete list of changes, including new sections with warnings about risks of using ocular corticosteroids, including risk of bacterial, viral, and fungal infections. Fluocinolone acetonide was approved in 1963; lluvien formulation was approved in 2014.
Iluvien FDA Safety Label Change
Read more about uveitis at Cleveland Clinic:
https://my.clevelandclinic.org/health/diseases/14414-uveitis
Metro I.V. (metronidazole) in Plastic Container for intravenous use
Metro I.V. label was updated in support of metronidazole’s expanded approval to treat complicated intra-abdominal infections in infants, including pre-term infants, from birth to less than four months of age. Includes clinical trials results evaluating the safety of metronidazole-containing regimens, which were administered for up to 10 days. Adverse events for the infants were comparable to patients receiving other antibacterial regimens in the study and generally similar to adverse reactions described in adults. Metro I.V. is not approved for this age group for other indications or for use in pediatric patients older than 4 months of age. Metro I.V. was approved in 1983.
Metro I.V. FDA Safety Label Change
Complicated intra-abdominal infections are common and often fatal in premature infants. Read these summaries about antibiotic safety and pediatric trials for use of metronidazole from the Pediatric Trials Network:
Safety of Metronidazole for Infants with Complicated Intra-Abdominal Infections
Antibiotic Safety in Infants with Complicated Intra-abdominal infections
Drug Recalls: Atomoxetine and Benzoyl Peroxide
Atomoxetine from Glenmark and Northstar
A nationwide recall is underway for 1.5 million bottles of atomoxetine (Straterra brand name), a popular ADHD (attention-deficit/hyperactivity disorder) drug, because of unacceptable levels of N-nitroso atomoxetine, a possible cancer-causing ingredient. The medications were made in India by generic manufacturer Glenmark Pharma and some are packaged by Northstar. This recall is directed at pharmacies, but consumers may check the FDA Enforcement Report with the recall list for affected products, which range in strength from 10 to 100 milligrams. Nitrosamine impurities occur due to manufacturing process problems.
FDA Enforcement report with list of recalled bottles of atomoxetine (scroll down the linked page to see the product list.)
Check out patient experiences with atomoxetine/Straterra (a non-stimulant ADHD medication) at Ask a Patient website.
In December 2024, 233,000 bottles of the generic antidepressant duloxetine (brand name Cymbalta) were also recalled due to nitrosamine impurities.
https://news.askapatient.com/i/153167678/duloxetine-antidepressant-recall-from-rising-pharmaceuticals
Acne Products Containing Benzoyl Peroxide
A recall is underway for six benzoyl peroxide-containing acne products by LaRoche, SLMD, Walgreens, and ProActive because the FDA found unacceptable amounts of benzene in the products. FDA says 90% of the 95 acne products it tested had undetectable or extremely low levels of benzene. An additional product, Zapzyt, is also under recall because of results of its own testing. Exposure to benzene can increase risk of cancer. The recall is directed at retailers, who are instructed to remove products from store shelves and from sale online. Check product names, lot numbers, and expiration dates here:
https://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show
In March 2024, independent testing laboratory Valisure brought the problem of benzene in acne products to the attention of the FDA.
https://news.askapatient.com/i/142698062/benzene-in-acne-products
Medication Tips: Statins, joint pain, liver enzymes, migraines
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