March 2025 Drug Safety Updates Part 1: Cardiac Risk Warning Removed for Testosterone Meds; News for Bactrim, Lybalvi, Nplate, Prolensa, Remicade, TNKase
FDA Removes Cardiac Risk Warning on Testosterone Products
In 2015, the FDA issued a warning to the public about cardiac risk related to prescription testosterone products like Androgel, Testim and Testosterone. These drugs are approved for adult males with low testosterone (hypogonadism) associated with a medical condition. Now, the FDA is reversing its position about cardiac risk, based on an assessment of a clinical trial study, called the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE). The study showed that the use of testosterone drug gel did not increase the risk of death from cardiovascular causes more than placebo.
Based on the new FDA directive, testosterone product labels will soon remove the current boxed warning about increased risk of heart attacks and strokes. The not-so-good-news is that testosterone products without a current warning about high blood pressure will soon have a new warning about risk of increased blood pressure, based on required post-market ambulatory blood pressure (ABPM) studies, which confirmed a class-wide increase in blood pressure with testosterone.
Read more about hypogonadism at MedLine Plus.
Joe Graedon of the People's Pharmacy discusses the FDA's latest assessment of testosterone health risk and suggests that the FDA has "seemingly ignored the question of whether low testosterone levels contribute to cardiovascular disease, especially in older men." He also presents examples of testosterone levels considered to be "normal" as reported by various medical sources.
https://www.peoplespharmacy.com/articles/is-the-fda-wrong-about-testosterone-heart-risk
Bactrim and Bactrim DS tablets; sulfamethoxazole and trimethoprim tablets, injection, oral solution; Sulfatrim pediatric oral suspension (sulfamethoxazole; trimethoprim)
Bactrim (sulfamethoxazole) treats adults and children age two months and older with bacterial infections including pneumonia, urinary tract infections and shigellosis. In June 2024, the FDA noted that it was evaluating the need for regulatory action regarding the risk of hemophagocytic lymphohistiocytosis. This month, the FDA acted on this evaluation by requiring a warning about the risk of hemophagocytic lymphohistiocytosis (HLH) for patients treated with sulfamethoxazole-trimethoprim.
HLH is a life-threatening immune response with symptoms of extreme systemic inflammation. Signs and symptoms of HLH often include fever, liver or spleen enlargement, rash, and swollen lymph nodes. Additional symptoms may include neurologic symptoms, high ferritin levels, anemia, high triglycerides, and liver enzyme and coagulation abnormalities. Patients are advised to discontinue the medication at the first sign of an adverse reaction. Bactrim was approved in 1973.
Bactrim DS FDA Safety Label Change (Bactrim and Bactrim DS tablets)
Sulfamethoxazole and Trimethoprim FDA Safety Label Change (tablets)
Bactrim and other sulfa drugs had additional safety updates in June 2024:
https://news.askapatient.com/i/146143459/sulfa-antibiotics-safety-label-updates
Lybalvi (olanzapine; samidorphan l-malate)
Lybalvi treats schizophrenia and bipolar 1 disorder in adults. The lactation section of the label adds that samidorphan is present in human breast milk, along with olanzapine. Infants exposed to Lybalvi should be monitored for excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements). In January 2025, the potential risk of breast cancer related hyperprolactinemia, or elevated prolactin levels, was added to the labels of Lybalvi and other antipsychotic drugs. Lybalvi was approved in 2021.
Lybalvi FDA Safety Label Change
Nplate (romiplostim) subcutaneous injection
Nplate treats low blood platelet levels in adults and children with immune thrombocytopenia (ITP), a condition where the immune system attacks the blood platelets, leaving the patient with an inadequate blood clotting response. Because Nplate might raise blood platelet levels too much, causing dangerous clotting, a new warning is added about the risk of thromboembolic complications, including blood clots in the leg veins (DVT or deep vein thrombosis) or lungs (PEP or pulmonary embolism). The label also now warns that portal vein thrombosis, or blood clots in the veins of the liver, is also a risk in patients with and without chronic liver disease. Nplate was approved in 2008.
Nplate FDA Safety Label Change
Prolensa (bromfenac sodium) eye drop solution
Prolensa treats post-operative inflammation and eye pain in patients who have undergone cataract surgery. It is a nonsteroidal anti-inflammatory (NSAID). The label now warns about the risk of medication contamination. Patients are advised not to touch the dropper tip to the eye, eyelids, or to any surface, and to replace the bottle cap after using. Prolensa was approved in 1997.
Prolensa FDA Safety Label Change
Remicade (infliximab) for injection, for intravenous use
Remicade treats Chron's disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases. The label warns that new onset immune disorders such as psoriasis, rheumatoid arthritis, and inflammatory bowel disease have been reported. Remicade was approved in 1998.
Remicade FDA Safety Label Change
Remicade patient ratings and reviews at Askapatient website
TNKase (tenecteplase)
TNKase recently received an expanded approval to treat acute stroke in adults and is also approved to reduce the risk of death associated with acute ST elevation (a type of heart attack). The most common adverse reaction is bleeding. The label adds a new section about the risk of bleeding, which can occur one or more days after administration of TNKase. Symptoms of bleeding include unusual bruising; pink or brown urine; red, black, or tarry stools; coughing up blood; vomiting blood or blood that looks like coffee grounds or symptoms of a stroke.
TNKase FDA Safety Label Change
Did you miss the last edition of Drug Safety Updates? Check it out here:
This week, we also posted an update with recent drug and device approvals. Check it out here:
https://news.askapatient.com/p/drug-and-device-approvals-deep-brain-stimulation-device
Please note that all REMS documents (for drugs requiring special safety programs) are now available on the FDA website. They had been unavailable for two weeks during February. We also have links to the REMS documents on our website.
Thank you for reading this edition of Ask a Patient Health News: Drug Safety Updates. Visit us at www.askapatient.com for patient-contributed drug and vaccine ratings and reviews.