Drug Safety January 2024 FDA Labeling Updates & Recalls
Drugs
The U.S. Food & Drug Administration (FDA) added a black box warning to Amgen’s osteoporosis drug Prolia (denosumab) because of the risk of severe hypocalcemia, (low calcium levels), in patients with advanced chronic kidney disease. Patients taking Prolia with CKD experiencing hypocalcemia were seriously harmed, with reports of increased bone fractures, hospitalization, life-threatening events, and death. Prolia was approved in 2010 to treat bone loss in postmenopausal women and later approved to treat men and women at high risk of fracture.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease
According to Fierce Pharma, the drug’s patent is set to expire in a year.
https://www.fiercepharma.com/pharma/fda-slaps-boxed-warning-amgens-osteoporosis-drug-prolia
Check here for a history of Prolia’s safety label changes, by date:
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=281
The FDA announced that its preliminary evaluation of GLP-1 drugs taken for diabetes or weight loss (like Ozempic, Mounjaro, Wegovy) has not shown a link to depression or suicidality. However, because of the small number of suicidal thoughts or actions observed in both people using GLP-1 RAs and in the comparative control groups, they cannot rule out a small risk; therefore, FDA is continuing to look into this issue. (Just recently, FDA had flagged these drugs for further investigation – see below information on semeglutide side effects).
https://www.fda.gov/drugs/drug-safety-and-availability/update-fdas-ongoing-evaluation-reports-suicidal-thoughts-or-actions-patients-taking-certain-type
The drug label for Regeneron’s Dupixent (dupilumab) was updated to include a new common side effect of dry eye. Also ,clinical trials information updates were added for pediatric studies. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1709
Devices: CPAP Mask Recall by ResMed
CPAP Mask Recall
The FDA issued a safety communication to alert patients, caregivers, and health care providers about certain recalled ResMed Ltd (ResMed) masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines (of various brands). The recalled masks have magnets that can cause potential injuries or death when they interfere with implanted metallic medical devices or metallic objects in the body. The potential malfunctions can also occur in in people (such as a caregiver) near a person using the mask. The masks should always be at least 6 inches away from metallic implants or objects.
The recall only applies to those who should not use the mask, including patients with:
• Active medical implants that interact with magnets, such as pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps.
• Metallic implants and objects containing ferromagnetic material, such as aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance, ocular implants, metallic splinters in the eye.
https://www.fda.gov/medical-devices/safety-communications/certain-resmed-ltd-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect-certain
ResMed has photos of affected products and more information:
https://document.resmed.com/documents/products/serviceandsupport/mask-magnet-support/Customer_FSN_English_US.pdf
The FDA has received multiple reports of new side effects for semaglutide and other glucagon-like peptide-1 (GLP-1) receptor agonists (like Ozempic, Victoza, Wegovy, Rybelsus, Saxenda, Byduren, Trulicity, Byetta and Mounjaro) through the FDA Adverse Events Reporting System (FAERS). It is “evaluating the need for regulatory action” with regard to these adverse events for 13 drugs in the category. The emerging side effects are: hair loss (alopecia), suicidal ideation or depression, and aspirating (airway obstruction). Gastrointestinal issues such as nausea, diarrhea and constipation are the most common side effects listed on GLP-1 drug labels, but the labels do not mention the hair loss, depression, or aspiration side effects. This page includes other drugs with potential signals for serious risks; scroll down to the middle for the GLP-1 drugs of concern.
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
Check Ask a Patient for reports of
Ozempic and breathing problems (only two reported)
The Hill reported on the FDA investigation of new side effects.
Related: Some patients taking GLP-1 drugs are experiencing other serious side effects. A man is suing Eli Lilly claiming that its Mounjaro drug caused a permanent condition of gastroparesis (when the stomach can't empty its contents). Business Insider reports that "Blake" had recently started taking the weekly diabetes medication Mounjaro and became very ill after just two injected doses. His doctors say that he'll probably have to live with gastroparesis for life.
https://www.businessinsider.com/mounjaro-lawsuit-alleges-stomach-is-paralyzed-from-glp-1-use-2023-12
Mounjaro reviews on Ask a Patient
All opioid pain medication labels were updated with various warnings, which included: meds should not be used for more than a few days for acute pain treated in an outpatient setting, the risk of overdose increases as the dosage increases for all opioid pain medicines, the risk of opioid-induced hyperalgesia (increase in pain), and other risks. Manufacturers of immediate-release and extended-release opioid pain drugs were notified in April 2023 of the required label changes, and the FDA announced the final approval and implementation of the label changes on December 15, 2023. About 70 drugs were affected including Actiq (fentanyl citrate), Codeine, Darvon, Dermerol, Methadone, Morphine, MS Contin, Nucynta, Suboxone, and more.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-safety-labeling-changes-opioid-pain-medicines
Many drug safety label changes were made to various drugs in the beta blockers category. Beta blockers are used to treat high blood pressure. The labels now warn that beta blockers may mask early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia.
Ziac: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2312
Lopressor: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2307
Atenolol (Tenoretic, Tenormin): https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2907