November 2024 Drug Safety Update Part 1: Botox Cosmetic and Dry Eye, Cardio Effects; Antifungals; Briumvi for MS; Biosimilars for Prolia and Stelara; Limbitrol Antidepressant; GLP-1 Meds
Consumer-friendly summaries of new safety information added to Food and Drug Administration (FDA) drug labels
Botox Cosmetic (onabotulinumtoxinA): New Indication and New Side Effects
Botox Cosmetic injection received FDA approval for treating the appearance of moderate to severe vertical bands that occur between the jaw and neck (platysma bands) in adults. Botox Cosmetic is now approved as treatment to improve the appearance of forehead lines, frown lines, crow's feet lines, and most recently, platysma bands. The drug label was updated with this new indication, along with a number of safety updates:
Providers are warned not to use Botox Cosmetic in the presence of infection at the proposed injection site, and to use caution when the injection site is inflamed or when excessive weakness or atrophy is present in the targeted muscle(s).
Cases of dry eye have been reported when the injection is in or near the orbicularis oculi muscle, which is the muscle around the eye that closes the eyelids and drains tears. (Check here for diagram showing oculi muscle.)
A new section was added on adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes.
Patients with preexisting neuromuscular disorders, such as motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored closely, because of increased risk of side effects.
There are also extensive changes to the clinical trials experience section of the label. Read the label for all the changes.
Botox Cosmetic was initially approved in 1989.
Botox Cosmetic FDA Safety Label Change
Patient reviews of Botox Cosmetic at Ask a Patient website
Antifungal Medications (posaconazole and itraconazole): Risk of Pseudoaldosteronism
Noxafil (posaconazole), Sporanox (itraconazole), and Tolsura (itraconazole) are medications used for treating or preventing a variety of fungal infections. Noxafil is taken to prevent invasive Aspergillus and Candida infections in high risk patients, such as those who are severely immunocompromised. Sporanox capsules are taken for similar reasons and also for fingernail or toenail fungus in non-immunocompromised patients. Tolsura is NOT interchangeable or substitutable with other itraconazole products and is approved to treat infections of Blastomycosis, Histoplasmosis, and Aspergillus in adults.
All three drugs had a safety label update to warn about the risk of new or worsening high blood pressure and low potassium levels in the blood (pseudoaldosteronism). It is also recommended that your healthcare provider should check your blood pressure and potassium levels.
The labels state that management of pseudoaldosteronism may include discontinuation of the medication, substitution with an appropriate antifungal drug that is not associated with pseudoaldosteronism, or use of aldosterone receptor antagonists. Noxafil was approved in 2006. Tolsura and Sporanox were approved in 1992.
Noxafil FDA Safety Label Change
Sporanox FDA Safety Label Change and Patient reviews of Sporanox at AskaPatient
Tolsura FDA Safety Label Change
Briumvi (ublituximab-xiiy) for Multiple Sclerosis
Injectable multiple sclerosis (MS) drug Briumvi had a safety label update to inform about potential safety risks to the fetus and to notify patients about the new Pregnancy Exposure Registry that monitors pregnancy outcomes in women exposed to Briumvi during pregnancy or when becoming pregnant within 6 months following their last dose. Briumvi was initially approved in 2022.
Briumvi FDA Safety Label Change
Selarsdi (ustekinumab-aekn), Biosimilar for Plaque Psoriasis drug Stelara
Selarsdi is a "biosimilar" (biologic generic) version of Stelara, and with its latest two approvals for Chron's disease and ulcerative colitis (UC), now treats the same four conditions as Stelara. Additionally, the Selarsdi drug label was updated to add these side effects for each indication, which were reported in clinical trials:
Crohn’s disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis.
Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis (bacterial infection).
Selarsdi, a single-dose vial for intravenous infusion or subcutaneous injection, was approved in 2024 and is expected to launch in first quarter 2025.
Selsardi FDA Safety Label Change
Curious about Stelara? Read patient reviews for Stelara at AskaPatient website.
Jubbonti (denosumab-bbdz), Biosimilar for Osteoporosis Treatment Prolia
Jubbonti injection treats bone loss (osteoporosis) in women who are at high risk for bone fracture after menopause and to treat bone loss in men who are at high risk for bone fracture. Its drug label was updated to report that in clinical trials of postmenopausal women, the most common adverse reactions are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
Jubbonti, a biosimilar for osteoporosis drug Prolia, was initially approved in March 2024.
Jubbonti FDA Safety Label Change
Curious about Prolia? Read patient reviews for Prolia at AskaPatient website.
Limbitrol (amitriptyline hydrochloride; chlordiazepoxide) and Severe Allergic Reaction
Limbitrol tablets treat moderate to severe depression that is associated with moderate to severe anxiety. Its ingredient amitriptyline HCL is also used to treat migraines and is contained in drugs like Elavil and Endep. Limbitrol also contains chlordizepoxide, a long-acting benzodiazepine that treats anxiety.
Limbitrol's drug label was updated to warn of "drug reaction with eosinophilia and systemic symptoms (DRESS)," a rare but severe allergic reaction to a medication that is accompanied by skin rash and affects internal organs. Limbitrol is available as a generic and was initially approved in 1977.
Limbitrol FDA Safety Label Change
Also called drug hypersensitivity syndrome, DRESS mainly affects adults. Read more on this topic here:
https://dermnetnz.org/topics/drug-hypersensitivity-syndrome
Liptruzet (atorvastatin calcium; ezetimibe) and Myasthenia Gravis
Liptruzet tablets are used to treat high cholesterol. The drug had a safety label update to warn of rare reports (either new onset or symptom exacerbation) of myasthenia gravis, including ocular myasthenia. Myasthenia gravis is a disease causing general muscle weakness, weakness in muscles used for breathing, and sometimes eye muscle weakness, ocular myasthenia. There have been reports of recurrence when the same or a different statin was administered.
Extensive changes were made to the Patient Information section of the label; please refer to the label for complete information.
Liptruzet was initially approved in 2013 and since 2021 has been sold under the branded generic name Lypqozet.
Liptruzet FDA Safety Label Change
GLP-1 Drugs: Zepbound and Victoza: Risk of Pulmonary Aspiration
Weekly injectable weight loss drug Zepbound (tirzepatide) had a safety label update to warn about the serious risk of pulmonary aspiration during general anesthesia or deep sedation. Pulmonary aspiration occurs when food or stomach contents are inhaled into the lungs. Patients taking Zepbound are advised to tell their healthcare provider if they are scheduled to have surgery or other procedures that use anesthesia or deep sedation. The medication guide also now includes the instruction that Zepbound should be used with a reduced-calorie diet and increased physical activity.
The clinical trials section of the label had extensive changes, which included the addition of reported side effects of dysgeusia (altered sense of taste) and dysethesia (unpleasant or altered sense of touch), which were experienced by a small number of patients. Zepbound was approved in 2022.
Zepbound FDA Safety Label Change
Weekly injectable diabetes drug Victoza had a drug safety label update to warn of the risk of pulmonary aspiration during general anesthesia or deep sedation. Pulmonary aspiration occurs when food or stomach contents are inhaled into the lungs. Victoza was approved in 2011.
Victoza FDA Safety Label Change Letter from FDA
Patient reviews of Victoza on AskaPatient website
As is noted in the FDA’s letter to Novo Nordisk regarding Victoza, the FDA has determined that new safety information about the risk of pulmonary aspiration should be included in the labeling for all GLP-1 drugs. Eventually, all of the GLP-1 drugs will update their labels to warn of the serious risk of pulmonary aspiration for patients undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.
Because of the delay in "gastric emptying" associated with the GLP-1 drugs like Ozempic, Zepbound, and Victoza, questions about the adequacy of traditional fasting guidelines before surgery have been raised by the medical community for more than a year.
For more on this topic, check out this special feature "Should you stop taking Ozempic Before Surgery?" (Anesthesiologists say yes, while gastroenterologists say not necessarily. Two recent studies shed new light on the topic.)
The FDA posted more than 20 drug safety labeling changes since our last update on October 20. In case you missed it, here’s the link from October 20:
Today’s newsletter covered only half of the FDA safety label changes received since our last edition, so we will send a Part 2 later this week, and Part 3 will be sent on Sunday, November 17. Additional updates will include those for heparin drugs (used to prevent or treat blood clots) and safety information for six cancer-related treatments. New drug approvals announcements also will be posted. Stay tuned!
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Please visit our website to read or add ratings and reviews of prescription drugs and some vaccines: www.askapatient.com
More on Ozempic
https://geoffpain.substack.com/p/stop-it-or-you-will-go-blind-nonarteritic