August 2024 Drug Safety Updates: iron deficiency anemia; high cholesterol; H.pylori; lupus; and 8 more meds
August 2024 Drug Safety Updates: iron deficiency anemia; high cholesterol; H.pylori; lupus; and 8 more meds
Consumer-friendly summaries of new safety information added to FDA drug labels
Iron deficiency anemia drugs
Three drugs used to treat iron deficiency anemia received drug safety label updates.
Venofer (iron sucrose)
Venofer infusion is used to treat iron deficiency anemia in patients with chronic kidney disease. Its label was updated to add post-marketing reports of cardiac-related adverse events, including heart attacks and bradycardia (low heart rate).
Label update for Venofer: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1379
Read or add reviews at Ask a Patient website for Venofer
Infed (iron dextran injection)
Patients age 4 months and up who have iron deficiency anemia who do not respond well to oral iron may be prescribed Infed injection. Infed’s update was similar to the Venofer update. Its label was changed to add the post-marketing reports of cardiac-related adverse events, including abnormal heart rhythms, reduced flow to heart, and heart attacks. (Note: Infed has a boxed warning for the risk of anaphylactic reactions.)
Labe update for Infed: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2333
Monoferric (ferric derisomaltose injection)
Monoferric is prescribed for adult patients who have iron deficiency anemia AND who do not respond well to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD). The “Prescribing Information” section of the label was updated to include various post-marketing experiences including general pain and malaise, respiratory side effect of bronchospasm, and skin conditions including skin exfoliation and skin swelling.
Label update for Monoferric: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2332
Cholesterol lowering drugs
Crestor (Rosuvastatin)
Crestor (rosuvastatin), one of the most commonly prescribed drugs to treat high cholesterol, received a safety label update to warn of certain drug interactions.
First, Ticagrelor (an antiplatelet drug that reduces risk of blood clots and is also known by the brand name Brilinta) may INCREASE the concentration of rosuvastatin in the blood, which may increase the risk of myopathy and rhabdomyolysis. Patients taking ticagrelor along with rosuvastatin should be monitored for signs and symptoms of myopathy (muscle weakness) or rhabdomyolysis (when muscle tissue breaks down and gets into the blood).
The label also notes that:
Cases of myopathy and rhabdomyolysis have been reported in patients using both products concomitantly. Cases have occurred more frequently in patients taking 40 mg of rosuvastatin.
Second, the label was also updated to change guidance about antacids. It has long been known that antacids (like aluminum and magnesium hydroxide-containing Tums) can decrease the amount of rosuvastatin in the blood. The label says:
Concomitant aluminum and magnesium hydroxide combination antacid administration decreased the mean exposure of rosuvastatin 50%
Previously the guidance was to take rosuvastatin at least two hours AFTER taking the antacid. Now, the label has changed to instruct patients to take Crestor two hours BEFORE taking the antacid.
Label update for Crestor: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=216
Cholesterol drug Antara (micronized) (fenofibrate)
Antara's label update includes clinical trials information and risk of serious hypersensitivity reactions. In particular, it is known that fenofibrate has not been shown to decrease the risk of heart attacks and strokes. Related clinical trials results from large studies were added to the label:
“Fenofibrate did not reduce cardiovascular disease morbidity or mortality in a large, randomized, placebo-controlled trial of patients with type 2 diabetes mellitus on background statin therapy…”
The label was also updated to include muscle pain and rhabdomyolysis risk, liver toxicity data, and warnings not to use in patients with liver disease, or severe renal impairment.
Label update for Antara: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1576
Fenofibrate reviews on Ask a Patient website
What’s the difference between fibrates (like Antara) and statins (like Crestor or rosuvastatin)? And who is a candidate for each kind of drug? Check out UCLA Health’s partial answer:
“Statins, more officially known as HMG-CoA reductase inhibitors, target cholesterol in the bloodstream, most of which comes from the liver, not from foods that we eat. Statins have undeniably shown benefits in decreasing the risk of both heart attacks and strokes; fibrates seem to have a more narrow benefit.”
“Significant elevation of triglycerides, greater than 400, can cause inflammation of the pancreas, so people with very elevated triglyceride levels would benefit from a fibrate medication. So too might those with elevated triglycerides and normal LDL cholesterols.”
Antibiotics
Cleocin (clindamycin HCL)
Cleocin is a common antibiotic prescribed for a variety of bacterial infections. Its label was updated to warn of the risk of esophageal irritation or esophagitis (also called GERD or acid reflux). To reduce that risk, the label says to follow the administration guidance, which includes taking the medication with a full glass of water (6 to 8 ounces) and to avoid lying down for at least 30 minutes afterwards.
Label update for Cleocin: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=279
Patient reports of esophagitis or GERD with Cleocin on Ask a Patient
Read more about esophagitis on MedlinePlus: https://medlineplus.gov/ency/article/001153.htm
Voquezna
This antibiotic, approved in 2022 for treating H.pylori and stomach ulcers, had a safety label update to warn of the risk of kidney infections:
Acute Tubulointerstitial Nephritis. If suspected, discontinue VOQUEZNA TRIPLE PAK or VOQUEZNA DUAL PAK and evaluate patients with suspected acute TIN.
The label also adds post-marketing reports of low blood platelets and reports a clinical effect that could lead to a false test result for a kind of neuroendocrine tumor:
Clinical Effect: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.
Label update for Voquezna: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2833
Note: The label updates for Voquezna include VOQUEZNA TRIPLE PAK (three drug combo) and VOQUEZNA DUAL PAK (two drug combo).
Read more about interstitial nephritis, including symptoms, on MedlinePlus:
https://medlineplus.gov/ency/article/000464.htm
Additional Label Updates
Beovu (brolucizumab-dbll)
BEOVU injection is a human vascular endothelial growth factor (VEGF) inhibitor that treats Neovascular (Wet) Age-Related Macular Degeneration.
The label was updated to warn of clinical trials incidents of “inflammation of the sclera.” The sclera is the white part of your eye.
Label update for Beovu: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2274
Inrebic (Fedratinib)
Myelofibrosis (MF) cancer drug Inrebic (Fedratinib) had a label update to advise that:
While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated.
Thiamine is Vitamin B1.
Label update for Inrebic: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2561
Darzalex Faspro (Daratumumab)
Targeted monoclonal antibody drug Darzalex Faspro ((Daratumumab) for multiple myeloma, a type of blood cancer, had a label update to warn of the risk of chylothorax. Chylothorax is a condition where fluid from the lymphatic system (chyle) leaks into the space around your lungs.
Label update for Darzalex Faspro: https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2999
Jemperli (dostarlimab-gxly)
Injectable endometrial cancer drug: Jemperli (dostarlimab-gxly) had its label updated to provide information on clinical trials results.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2613
Erleada (apalutamide)
The label for prostate cancer drug Erleada (apalutamide) was updated to include a new section on the risk of interstitial Lung Disease (ILD) along with other updates.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2063
Sucraid (sacrosidase) Oral Solution
Sucraid (sacrosidase) Oral Solution (enzyme replacement therapy for the treatment of congenital sucrase-isomaltase deficiency) had a safety label update to include a new section on hypersensitivity risks, including wheezing, rash, and itching. It also includes data supporting the approval for use in patients 5 months and older.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3000
Fotivda (tivozanib hydrochloride)
Kidney cancer drug Fotivda (tivozanib hydrochloride) had a safety label update to warn of risk of gastrointestinal perforation.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3001
Saphnelo (anifrolumab-fnia)
Once-monthly injectable lupus treatment Saphnelo (anifrolumab-fnia) had its label updated to include warning about risk of arthralgia (joint pain).
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2887
