June 2025 Safety Update Part 2: Warnings for Transderm Scop, Caprelsa, Hyzaar, Xarelto, GLP-1s (Mounjaro and more)
Transderm Scop (scopolamine) patch and Hyperthermia
The FDA issued a Drug Safety Communication about the serious risk of hyperthermia, or overheating, for motion sickness drug Transderm Scop (scopolamine transdermal system). The scopolamine-containing patch is applied behind the ear and delivers 1 mg of medicine over about 3 days.
The medication can affect the body’s ability to maintain a stable internal temperature and can also reduce sweating, which may contribute to an increase in core body temperature. Heat-related complications may lead to confusion, loss of consciousness, coma, or death. In reported cases, hyperthermia occurred most often within 72 hours after the Transderm Scop patch was applied for the first time. The FDA notes that warm environmental temperatures and use of external heat sources, such as a heated blanket, exacerbate the risk.
Patients using the patch who have a high body temperature or are not sweating in warm conditions should remove the patch and contact a doctor. People over the age of 65 and those under the age of 17 may be at greater risk of hyperthermia. (The med is not approved for pediatric patients, but is sometimes prescribed “off-label.”) Transderm Scop was approved in 1979.
FDA Announcement: “FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)”
Transderm Scop FDA Safety Label Change
Read or add ratings for Transderm Scop at Ask a Patient website.
Caprelsa (vandetanib) tablets and Osteonecrosis of the Jaw
Thyroid cancer treatment Caprelsa had a safety update to warn that osteonecrosis, including osteonecrosis of the jaw (ONJ), has occurred during treatment. Exposure to denosumab (Prolia brand name) or bisphosphonate drugs like alendronate (brand name Fosamax) may increase the risk of ONJ. Patients should avoid invasive dental procedures while taking Caprelsa. Caprelsa was approved in 2011.
In people with healthy bones, new bone is always replacing old bone. In osteonecrosis, the bone breaks down faster than the body can make enough new bone. https://rheumatology.org/patients/osteonecrosis-of-the-jaw-onj
Read more about osteonecrosis at MedLine Plus
Caprelsa Safety Label Change, and Revised Drug Label
Hyzaar (hydrochlorothiazide; losartan potassium) tablets and Angioedema
Blood pressure drug Hyzaar now warns that angioedema (swelling) side effects have included swelling of the intestines, or “visceral angioedema.” Hyzaar is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic or “water pill.” Hyzaar was originally approved in 1994.
Rare case reports of losartan-induced visceral angioedema have been reported in the medical literature.
Hyzaar FDA Safety Label Change
Read or add ratings for Hyzaar at AskaPatient website.
Xarelto (Rivaroxaban) Tablets, Oral Suspension and Risk of Spleen Rupture
Xarelto treats and prevents deep vein thrombosis or DVT (a type of blood clot usually in the leg) and pulmonary embolism, which is a blood clot in the lung. The medication is also taken to prevent strokes and blood clots in people with atrial fibrillation that is not caused by heart valve disease.
Xarelto has a new warning about the risk of internal bleeding from any organ and also warns about the risk of spleen rupture. Patients are advised to get medical help right away if they experience symptoms of a ruptured spleen: upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder or diffuse abdominal discomfort. Xarelto was originally approved in 2011.
Xarelto Safety Label Change, and Revised Drug Label
Read or add ratings for Xarelto at Ask a Patient website.
GLP-1 Drugs and Kidney Injury
GLP-1 drugs are used to treat type 2 diabetes and/or weight loss. Many of the drugs in the category have new warnings about the risk of serious kidney injury caused by dehydration that is associated with GLP-1 gastrointestinal adverse effects like diarrhea and vomiting. The labels have also been edited for a more uniform presentation of side effects and risk information for the drugs in the GLP-1 category.
Some of the GLP-1 drug labels were also updated to add that there have been post-marketing reports of hair loss (alopecia) and the neurological symptom of “altered sense of touch,” or dysesthesia. Ozempic, Rybelsus, and Zepbound already had made all of these changes, so were not included in the recent updates received by the FDA. GLP-1s with strengthened warnings about kidney injury include:
Bydureon BCISE extended-release (exenatide synthetic) subcutaneous weekly injection (approved in 2017)
The postmarketing experience section also now includes reports of dysesthesia (altered sense of touch). Bydureon Extended Release Safety Label Change
Byetta (exenatide synthetic) subcutaneous twice-daily injection (approved in 2005)
The postmarketing experience section also now includes reports of dysesthesia (altered sense of touch). Byetta FDA Safety Label Change
Mounjaro (tirzepatide) subcutaneous weekly injection (approved in 2022) The postmarketing experience section also now includes reports of alopecia (hair loss).
Mounjaro FDA Safety Label Change
Soliqua 100/33 (insulin glargine and lixisenatide) subcutaneous daily injection (approved in 2016) The postmarketing experience section also now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch). Soliqua FDA Safety Label Change
Trulicity (dulaglutide) subcutaneous weekly injection (approved in 2014)
Added new clinical trials reports of stomach problems (gastrointestinal effects). Trulicity FDA Safety Label Change
Victoza (liraglutide) subcutaneous daily injection (approved in 2010) Victoza FDA Safety Label Change
Xultophy 100/3.6 (insulin degludec and liraglutide) subcutaneous daily injection (approved in 2016) The postmarketing experience section also now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch). Xultophy FDA Safety Label Change
Saxenda (liraglutide) subcutaneous daily injection (approved in 2014)
The postmarketing experience section also now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch). Saxenda FDA Safety Label Change
GLP-1 Drugs and Pancreatitis
The U.K.’s Medicines and Healthcare products Regulatory Agency’s (MHRA) will be investigating adverse effects of GLP-1 drugs on the pancreas. This is in response in an increase in reports of acute pancreatitis to the MHRA Yellow Card scheme, which monitors adverse reactions to medications and medical devices in the UK.
The Guardian: “Hundreds of weight loss and diabetes jab users report pancreas problems”
Medication Tips: Cancer Treatments
Chemocare website is a resource for patient and caregivers with questions about cancer drugs. Find out what you should tell your health care team before starting a treatment, learn about drug interactions, how to store it (if applicable), side effects to expect, and self-care tips. The resource covers everything from novel immunotherapies and targeted radioligand treatments to taxane-based chemotherapies. The “Cancer Answer Line” at 1.844.268.3901 has advanced practice nurses and coordinators who will answer cancer-related concerns of patients, non-patients, caregivers, and even physicians (from 8am to 4:30pm EST). The site is hosted by Cleveland Clinic.
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