October 2024 Drug Safety Update Part 2: Skin Conditions, Eye disease, Leukemia, Lung, Malaria, Overactive Bladder, Type 2, and Tuberculosis treatments
Consumer-friendly summaries of new safety information added to FDA drug labels
Dermatologic Drugs: Ameluz for Actinic Keratosis and Cosentyx for Plaque Psoriasis
Ameluz, in combination with photodynamic therapy (PDT) using a red light illumination source, treats actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp. AKs are rough, scaly skin patches that can be precancerous. The drug label was updated to add a section on opthalmic adverse reactions, including eyelid swelling and dry eyes.
Patients are advised to avoid direct contact of Ameluz with the eyes or with the mucous membranes and to rinse with water in case of accidental contact. The light illumination BF-RhodoLED and RhodoLED are branded companion PDT devices that work with this drug. Ameluz was initially approved in 1999.
Extensive changes were made to the clinical trials reporting section. Please see complete label for details.
Ameluz FDA Safety Label Change
Cleveland Clinic description of actinic keratosis:
https://my.clevelandclinic.org/health/diseases/14148-actinic-keratosis
Plaque psoriasis drug Cosentyx (secukinumab) had a label update to warn that serious adverse reactions including anaphylaxis and angioedema (swelling) have occurred during post-approval use of the injectable drug. Patients who experience serious allergic reactions are advised to immediately discontinue Cosentyx and seek appropriate therapy. Cosentyx was initially approved in 2015.
Cosentyx FDA Safety Label Change
Patient ratings and reviews of Cosentyx at Ask a Patient
Eye Disease Drugs: Xelpros, Durysta for Glaucoma; Eyelea for Wet AMD
Xelpros (latanoprost) daily eye drops for glaucoma
Glaucoma drug Xelpros' drug label was updated to add the adverse effects of gastrointestinal disorders, including nausea and vomiting. Xelpros was approved in 1996.
Xelpros FDA Safety Label Change
Durysta (bimatoprost) dissolvable implant for glaucoma
Durysta is a surgically injected biodegradable implant that treats open angle glaucoma (OAG) or ocular hypertension (OHT) with a slow release of the bimatoprost over a period of about six months, eliminating the need for patients to use daily eye drops. The drug label was updated to warn of clinical trials occurrences of corneal thickening (in less than 1% of patients). Also, the label reports post-marketing experiences of a serious eye inflammation condition called endophthalmitis. Durysta was approved in 2020.
Durysta FDA Safety Label Change
Read more about the Durysta treatment:
https://www.aao.org/eyenet/article/bimatoprost-implant-glaucoma-management
Eyelea and Eyelea HD (aflibercept) Injection for Wet AMD
Wet Age-Related Macular Degeneration (AMD)/ Macular Edema/diabetic retinopathy treatment Eyelea had a safety label update to add the adverse effect of scleritis. Scleritis is the inflammation of the sclera, or white part of your eye. Redness and swelling, or pain and tenderness in the eye can be symptoms. Eyelea was initially approved in 2011.
Eyelea FDA Safety Label Change
Eyelea HD FDA Safety Label Change
Cleveland Clinic explanation of scleritis
Leukemia Drug: Vesanoid (tretinoin) capsules
Vesanoid is a retinoid (vitamin A-derived drug) used to induce remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL). The drug label was updated to warn about interactions with substances that affect enzymes involved in metabolizing drugs, called CYP3As.
CYP3A Inhibitors: Patients are advised against using Vesanoid with strong CYP3A inhibitors, which may INCREASE the concentration of Vesanoid in the blood. If use is required, patients should be monitored closely. Examples of CYP3A inhibitors include antifungal medications like ketoconazole, Itraconazole, voriconazole, and posaconazole, protease inhibitors used to treat HIV, along with some antibiotics like clarithromycin and grapefruit juice components.
CYP3A Inducers: Drugs and substances that are CYP3A inducers, including phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids should also be avoided, as they might DECREASE the drug concentration in the blood.
Vesanoid was initially approved in 1995.
Vesanoid FDA Safety Label Change
Note: Tretinoin capsule should not be confused with Isotretinoin capsule (brand names Accutane or Zenatene), which is a different retinoid and is used for treating cystic acne. Retin-A (tretinoin cream or gel) is a topical medication used to treat acne.
Lung Disease Drug: Ofev (nintedanib esylate) capsules
Interstitial lung disease and Idiopathic Pulmonary fibrosis (IPF) drug Ofev (nintedanib esylate) had a drug safety label update to warn of reported cases of a nervous system disorder called "Posterior reversible encephalopathy syndrome." (PRES). PRES typically has a rapid onset of symptoms such as headache, seizures, altered consciousness, and visual disturbance. Ofev was initially approved in 2014.
Ofev FDA Safety Label Change
Read about PRES in this StatPearls article. PRES is rare but sometimes occurs with sudden-onset of hypertension.
Posterior Reversible Encephalopathy Syndrome
Malaria Treatment: Sovuna (hydroxychloroquine sulfate) tablets
Malaria treatment Sovuna (hydroxychloroquine sulfate tablets) had its label updated to explain that the product cannot be directly administered to pediatric patients weighing less than 23 kg (50 pounds) because the lowest possible dose of 150 mg (half of the scored 300 mg tablet) exceeds the recommended dose for these patients .
Also, in the patient counseling information section, the label was updated to include the risk of liver toxicity in patients with porphyria cutanea tarda (a skin blister condition caused by defect in a liver enzyme). Patients are advised to seek medical attention if experiencing liver toxicity symptoms like fatigue, rash, nausea, dark urine, or jaundice. Sovuna was initially approved in 2022.
Sovuna FDA Safety Label Change
Overactive Bladder Treatment: Gemtesa (vibegron) tablets
Gemtesa (vibegron) tablets are used to treat overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. Its drug label was changed to add the risk of anangioedema (swelling) to the face, lips, tongue, throat or larynx, with or without difficulty breathing. Gemtesa was initially approved in 2020.
Gemtesa FDA Safety Label Change
Type 2 Diabetes Treatment: Onglyza (saxagliptin hydrochloride) tablets
Type 2 diabetes drug Onglyza had a drug safety label update to advise that because insulin and "insulin secretagogues" (such as glipizide, a diabetes drug that stimulates the release of insulin) are known to cause hypoglycemia (low blood sugar), lower dosages of these may be required when taken along with Onglyza.
The label update reports that clinical trial results did NOT show Onglyza to be effective at improving glycemic control in pediatric patients (age 10 to 17 years).
The label also now adds that patients should not crush or chew the tablets, which are taken once a day. The Medication Guide had extensive changes; see the full label for details. Onglyza was initially approved in 2009.
Onglyza FDA Safety Label Change
Onglyza works by increasing levels of natural substances called incretins, which help to stimulate release of insulin after a meal. Januvia is an example of another diabetes drug that works by increasing levels of incretins.
Read or add reviews for Onglyza at Ask a Patient.
Tuberculosis Drugs: Ridafin (rifampin capsule and I.V.) and Rifater tablets
Ridafin (rifampin) is a treatment for all forms of tuberculosis. The drug interactions section of the label was updated to warn of its effect on the antifungal drug caspofungin. Healthcare providers are advised to refer to the caspofungin prescribing information for caspofungin dose adjustment. Rifadin injection was initially approved in 1989; capsules were initially approved in 1971 and both formulations are available as generics.
Ridafin FDA Safety Label Change
Rifater (isoniazid; pyrazinamide; rifampin) is used as a short-course treatment for pulmonary tuberculosis. The drug interactions section of the label was updated to warn of its effect on the antifungal drug caspofungin. Healthcare providers are advised to refer to the caspofungin prescribing information for caspofungin dose adjustment.
Also, the isoniazid active ingredient of Rifater has resulted in reports of the adverse reaction of alopecia (hair loss). Rifater was initially approved in 1994.
Rifater FDA Safety Label Change
Did you miss our Part 1 of the October Drug Safety Update? View it here:
Please note: The regular Drugs and Treatments News is on break this week. In the meantime you can browse through recent editions here:
https://news.askapatient.com/archive
We recently revised our article on the World Health Organization’s list of essential medicines in the mental health category. The list is updated every two years, with the next one scheduled for 2025. Check out: “Changes to Model List of Essential Medicines for Mental and Behavioral Disorders” Medicines deemed essential for treating depression, bipolar disorders, anxiety disorders, obsessive compulsive disorders, psychotic disorders, and substance abuse are listed.
https://www.askapatient.com/news/essential-medicines-for-mental-and-behavioral-disorders.asp
Visit us at AskaPatient.com for patient-contributed drug ratings and reviews and more news.