September 2024 Part 2 Drug Safety Updates: Veozah and liver injury, 4 autoimmune drugs, glaucoma drops, weight loss med and heart rate
Consumer-friendly summaries of new safety information added to FDA drug labels
Veozah (fezolinetant) and Liver Injury
The Food and Drug Administration (FDA) issued a safety communication for the increasingly popular non-hormonal menopause hot flashes drug Veozah (fezolinetant) to warn of the risk of rare but serious liver injuries. FDA Safety Communications are not routine* and represent important FDA safety messages to be widely disseminated to the public. The FDA reports that the number of patients using the once-daily fezolinetant pill has steadily increased since its approval in May 2023: in May 2024, 28,700 prescriptions were dispensed.
The FDA changed the Veozah label to report on a case of severe liver injury attributed to the drug that it says could have been avoided with more frequent testing of liver enzymes. It sets new requirements for such testing: tests to evaluate for hepatic function and injury should not only be done prior to starting the drug (baseline), but also monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.
The label also now recommends that the treatment be discontinued and health care provided contacted if a patient experiences the following signs or symptoms, which could indicate liver injury:
feeling more tired than you do usually
nausea
vomiting
itching
yellowing of the eyes or skin (jaundice)
pale feces
dark urine
pain in the right upper stomach (abdomen)
If there are signs suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal.
FDA Drug Safety Communication for Veozah
Veozah Drug Safety Label Change
Public Citizen’s Health Research Group designated fezolinetant (Veozah) as a “do not use” drug because “its limited benefits for vasomotor symptoms did not outweigh the safety concerns that were already known, such as abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated values on liver blood tests.”
https://www.worstpills.org/e-alerts/view/146
*The last FDA Safety Communication was in January 2024 when FDA added a Boxed Warning for osteoporosis drug Prolia (denosumab) for increased risk of severe hypocalcemia (low calcium levels) in patients with advanced chronic kidney disease, CKD.
Additional Drug Safety Label Changes
Cimzia (certolizumab pegol injection)
Cimzia is a tumor necrosis factor (TNF) blocker used to treat a variety of autoimmune diseases including Chron’s disease and rheumatoid arthritis. It is administered by subcutaneous injection by a healthcare professional or sometimes (with physician approval) is self-injected by the patient. Cimzia has now been approved for pediatric patients age 2 and up for polyarticular juvenile idiopathic arthritis, which is a subtype of juvenile idiopathic arthritis (formerly known as juvenile rheumatoid arthritis). In this update, pediatric clinical trials results were added.
The pediatric clinical study included 193 patients and concluded that in general, the safety profile for pediatric patients was similar to the safety profile seen in adult RA patients treated with Cimzia. However, there were 26 serious infections; the most frequently reported serious infection was pneumonia.
Also, the label now warns to avoid using live vaccines immediately prior to beginning use of Cimzia, in addition to during use.
Cimzia FDA Safety Label Change
For symptoms and causes of juvenile idiopathic arthritis, read this Mayo Clinic article.
Dupixent (dupilumab)
Eczema drug Dupixent’s approval was expanded for use by children age 12 and up as add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Its label was updated to include clinical trials and safety data for adolescents. The safety profile of Dupixent in adolescents was similar to the safety profile from studies in adults, with injection site reactions being the most common adverse reaction. Dupixent is already approved for children age 6 months and up for moderate to severe asthma and eczema.
Dupixent FDA Safety Label Change
Enbrel (etanercept)
Rheumatoid arthritis (RA) drug Enbrel had a safety label update to include post-marketing reports of urinary and kidney adverse effects, including glomerulonephritis, a condition where the glomeruli (tiny filters in the kidney) become inflamed. Symptoms might include reddish urine, high blood pressure, or fluid retention.
Enbrel FDA Safety Label Change
Invega Hafyera (paliperidone palmitate)
Invega Hafyera is a once-every-six-months injection that that treats schizophrenia in adults. It is to be used only after an adequate course of treatment with once-a-month and once-every-three-months injections with paliperidone palmitate (such as Invega Sustenna and Invega Trinza). The safety label update expands the use of the drug to allow for its use by those with mild renal impairment. It notes dosage instructions for those with mild renal impairment, which are based on previous doses received. Note that although the safety label update is listed under Invega Trinza, this update only applies to Invega Hafyera, as the two drugs share the same FDA application number.
Invega Hafyera FDA Safety Label Change
Iyuzeh (latanoprost)
Iyuzeh are eye drops that treat glaucoma. The label update warns of post-marketing occurrences of gastrointestinal side effects, including nausea and vomiting.
Iyuzeh FDA Safety Label Change
Methotrexate (methotrexate) injection
Methotrexate injection is used to treat certain types of cancer, usually as part of a combination chemotherapy regimen. The label was updated to include the adverse reactions of injection site necrosis or other injection site reactions. The effects were identified in post-marketing reports or clinical trials.
(Note: this drug is not the same as methotrexate tablets, which are used to treat theumatoid arthritis and severe psoriasis in addition to cancer.)
Methotrexate injection FDA Safety Label Change
Qsymia (phentermine and topiramate extended-release capsules)
Weight loss pill Qsymia had a safety label change to clarify clinical trials information about increases in heart rates:
“In an 8-week ambulatory blood pressure monitoring (ABPM) study in adults, Qsymia increased the 24-hr average heart rate by 3.6 beats per minute (bpm) compared to the placebo group.”
Also, the description of pediatric and adult use was modified, to remove the term “BMI” and instead use the term “obesity.” For pediatric use, the indication changed from treatment of patients with “initial BMI in the 95th percentile” to “as an adjunct to a reduced-calorie diet and increased physical activity for weight reduction and long-term maintenance …in pediatric patients aged 12 years and older with obesity.”
Note: There has been a movement in the medical community to shift away from using BMI alone as a measure of individual health.
Qsymia FDA Safety Label Change
Tremfya (guselkumab)
Plaque psoriasis drug Tremfya received expanded approval for moderate to severe ulcerative colitis (U.C.) and its recent safety label update provides related clinical trials information. Also, the label includes warnings of adverse pregnancy outcomes, such as preterm delivery and low birth weight. Other extensive changes are included on the revised label.
Tremfya FDA Safety Label Change
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