April 2025 Drug Safety: Lidocaine cream; new side effects for migraine drugs; antidepressants study; Pluvicto for prostate cancer; Imfinzi; Tymlos; vitamin B-12 quality; microplastics in teabags
Consumers Warned about Some Topical Lidocaine Products
The FDA is warning consumers not to use certain over-the-counter topical analgesic creams, gels, and sprays that are being illegally marketed to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. These products have higher concentrations of lidocaine than are allowed in over-the-counter lidocaine products, which could lead to serious injury. Some of the products contain added drugs like epinephrine which could be dangerous. Check the six companies, associated products, and websites where the products are sold.
https://www.askapatient.com/news/lidocaine-topical-drugs-new-warnings.asp
Migraine Headache Drugs: New Side Effects
Reports of two additional adverse effects were added to the labels of six drugs that prevent and/or treat migraine headaches. High blood pressure and risk of Raynaud’s Phenomenon (a type of circulation problem) have been reported for: Aimovig, Qulipta, Ajovy, Ubrelvy, Zapzet, and Emgality, and Nurtec ODT.
New Warnings for Migraine Headaches Drugs - Ask a Patient
Imfinzi (durvalumab) for intravenous infusion
Imfinzi is an immunotherapy that treats different kinds of cancer, including NSCLC (non-small cell lung cancer), small cell lung cancer (SCLC), liver cancer and endometrial cancer. Its safety label was updated to include clinical trials results and updated side effects for its recent approval for muscle invasive bladder cancer (MIBC), a type of cancer that has spread into the muscle layer of the bladder but not to other parts of the body.
The most common side effects when used for MIBC include low red blood cells (anemia), low white blood cells, constipation, increased level of creatinine in the blood, decreased level of magnesium in the blood, decreased appetite, nausea, and more. See label update for complete details. Imfinizi was approved in 2017.
Imfinzi FDA Safety Label Change
FDA issued a press release about Imfinzi's new approval for bladder cancer.
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use
Prostate cancer drug Pluvicto received expanded approval to treat metastatic castration-resistant prostate cancer (mCRPC). Pluvicto may now be used by adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy (such as enzalutamide or Xtandi brand name), but not necessarily chemotherapy. Previously, patients were required to have already tried both kinds of treatments in order to be eligible to be screened for Pluvicto.
Patients are screened using a companion PSMA positron emission tomography (PET) scan (such as Locametz) that measures PSMA expression in tumors. The drug label was updated with clinical trials data that support the expanded approval. The number of patients eligible for the treatment is expected to triple with this expanded approval.
The revised label provides additional warnings about the risk of myelosuppression (decrease in the production of blood cells) and renal toxicity (kidney injury). Patients are advised to remain well hydrated and to urinate frequently. Healthcare providers should perform kidney function laboratory tests and monitor complete blood counts. Pluvicto was approved in 2022.
Pluvicto FDA Safety Label Change
FDA issued a Press Release about Pluvicto’s expanded approval for prostate cancer.
Read more about Pluvicto, a unique “radiopharmaceutical” that delivers radiation directly to tumors without affecting surrounding cells, in our post from last year that includes comments from radiation oncologist Dr. Stacy Wentworth (writer of the newsletter Cancer Culture).
https://news.askapatient.com/i/144784960/radiation-oncology-promising-treatments
Check out this information from the Prostate Cancer Foundation that answers the question: “I have metastatic castrate-resistant prostate cancer (mCRPC). Could I benefit from PSMA-targeted radioligand therapy?”
https://www.pcf.org/c/will-psma-targeting-radioligand-therapy-be-helpful-for-me/
Tymlos (abaloparatide) injection, for subcutaneous use
Osteoporosis drug Tymlos had a label change to warn about post-marketing reports of patients experiencing increases in blood pressure. Tymlos was approved in 2017.
Tymlos FDA Safety Label Change
Drug Research: Antidepressants and Sudden Cardiac Death
A University of Copenhagen study presented at the European Society of Cardiology Congress (ERHA 2025) found that individuals with a history of antidepressant use have an increased risk of sudden cardiac death, which varies based on age and time of exposure, compared with individuals with no history of antidepressant use. The researchers define sudden cardiac death as “an unexpected death of a person, believed to be caused by a heart-related issue… occurring within one hour of the onset of symptoms in witnessed cases or within 24 hours of the person being last seen alive in unwitnessed cases.”
The study analyzed health and death records for 4.3 million residents in Denmark aged 18-90 years for the year 2010. That year there were a total of 45,701 deaths and 6002 cases of sudden cardiac death. Of the 643,999 residents who had a recent history of antidepressant use, there were 1,981 sudden cardiac deaths. This compares with 4,021 sudden cardiac deaths among people without a history of antidepressant use. The incidence rate ratio of sudden cardiac death was significantly higher for antidepressant users across all age groups except for the age group 18-29 years, for whom the association was not statistically significant.
Researchers also found a greater risk of sudden cardiac death for individuals taking antidepressants for longer periods of time. When the data was adjusted for age, sex and comorbidities, the group exposed to antidepressants for 1 to 5 years had a 56% higher risk of sudden cardiac death, while those exposed to antidepressants for six or more years experienced a 2.2 times higher risk.
Note: Specific antidepressants used by individuals were not identified in the study. Also, the researchers acknowledge that having a psychiatric disorder is independently associated with sudden cardiac death. Patients with schizophrenic disease have the highest rates of sudden cardiac death.
Press Release: https://www.escardio.org/The-ESC/Press-Office/Press-releases/Use-of-antidepressant-medication-linked-to-substantial-increase-in-risk-of-sudden-cardiac-death
Study: Mujkanovic, J., Warming, P. E., Kessing, L. V., Køber, L. V., Winkel, B. G., Lynge, T. H., & Tfelt-Hansen, J. (2024). Nationwide burden of sudden cardiac death among patients with a psychiatric disorder. Heart, 110(23), 1365–1371.
Supplements Tips: Green Tea and Vitamin B-12
Green Tea Bags and Microplastics
While many people drink green tea for its health benefits, some consumers may unknowingly be ingesting microplastics along with the tea. Nylon or plastic-containing tea bags can release billions of microplastics particles into each cup of steeped tea, according to independent testing laboratory Consumer Lab. They surveyed makers of bagged green tea and found that brands containing plastic include Kirkland (Costco) and Trader Joes, who reported using a very small amount of “acrylic binder and PAE (Poly-Amide-Epichlorohydrin).”
Tetley brand tea bags are compostable but may be heat sealed, meaning that they may contain a very small amount of plastic, according to Consumer Labs. Twinings reported that its enveloped tea bags are made from tea paper (wood pulp) and are folded and tied with string. Additional companies that state they do not use any plastic in their teabags include Yogi, Stash, and Tazo. Lipton and Celestial Seasonings brands have not yet responded to the survey. An option to avoid microplastics is to steep loose tea with a metal tea ball.
Consumer Lab: Green Tea Review: Tea Bags, Loose Leaf Tea, Matcha Powders, and Supplements
(article is paywalled; membership required to view; this article also includes test results for levels of heavy metals, caffeine, antioxidants, and green tea polyphenols.)
Vitamin B-12 Supplements Sold on Amazon Fail Potency Testing
Natural products company NOW Foods tested 25 different brand samples of Methyl B-12 (Vitamin B-12) purchased on Amazon in January 2025. These included liquids, lozenges, and tablets. Since Vitamin B-12 is found in meat, poultry, fish, and dairy products, not plant-based foods, these supplements are often taken by vegetarians. Test results showed 11 brands exceeded their label claim for the vitamin, with six testing over 120%. 12 brands tested below 100%, with three showing potency between 90-100%, while three brands contained only 0-1% potency.
An example of a brand with 0% potency was a 90-tablet bottle from Nextdia, CA. Check link below for a description of testing methodology and a table with results by brand name. Brands that failed potency testing are marked with the symbol ⚠︎ . NOW says it reported the results to both Amazon and the FDA.
https://www.nowfoods.com/healthy-living/articles/nows-testing-methyl-b-12-brands-amazon
Why do you need Vitamin B-12?
“Vitamin B-12 (cobalamin) plays an essential role in red blood cell formation, cell metabolism, nerve function and the production of DNA, the molecules inside cells that carry genetic information. Left untreated, a vitamin B-12 deficiency can lead to anemia, fatigue, muscle weakness, intestinal problems, nerve damage and mood disturbances.”
(from MayoClinic)
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