Monthly Archives: November 2023

The U.S. Food and Drug Administration has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or post marketing adverse event (AE) data sources.

FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies. T-cell malignancies have occurred in patients treated with several products in the class. Currently approved products in this class (listed alphabetically by trade name) include the following:

• Abecma (idecabtagene vicleucel)
• Breyanzi (lisocabtagene maraleucel)
• Carvykti (ciltacabtagene autoleucel)
• Kymriah (tisagenlecleucel)
• Tecartus (brexucabtagene autoleucel)
• Yescarta (axicabtagene ciloleucel)

Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and evaluating the need for regulatory action.

Patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies. In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene.

To report suspected adverse events including T cell malignancies, contact the FDA at 1-800-FDA 1088 or www.fda.gov/medwatch.

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The U.S. Food and Drug Administration is warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). It may start as a rash but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, we are requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.

This hypersensitivity reaction to these medicines is serious but rare. DRESS can include fever, rash, swollen lymph nodes, or injury to organs including the liver, kidneys, lungs, heart, or pancreas.

What is FDA doing?

The FDA is requiring manufacturers of these medicines to add new warnings about DRESS to the prescribing information and the Medication Guide for patients and caregivers. For levetiracetam (Keppra, Keppra XR, Elepsia XR, and Spritam), this involves adding a new warning in the Warnings and Precautions section of the prescribing information, which describes the most serious and significant potential safety issues. Currently the symptoms associated with this condition are described less prominently.

For clobazam (Onfi and Sympazan), the FDA is requiring a new warning specifically about DRESS to be added to the prescribing information. Symptoms related to this risk are already described more generally in other sections of the clobazam prescribing information.

FDA reviewed worldwide cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with levetiracetam and clobazam in children and adults reported to the FDA Adverse Event Reporting System (FAERS) database and can be found in the medical literature.

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FDA Approves Ogsiveo for Adults with Desmoid Tumors

SpringWorks Therapeutics, Inc., announced today that the U.S. Food and Drug Administration has approved Ogsiveo™ (nirogacestat), an oral gamma secretase inhibitor, for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. The FDA previously granted breakthrough therapy, fast track, and orphan drug designations to nirogacestat for the treatment of desmoid tumors.

Desmoid tumors are locally aggressive and invasive soft-tissue tumors that can lead to substantial morbidity. In addition, when vital structures are impacted, desmoid tumors can be life threatening. Although they do not metastasize, desmoid tumors are often refractory to existing off-label systemic therapies and associated with recurrence rates of up to 77% following surgical resection. Desmoid tumor experts and treatment guidelines now recommend systemic therapies as first-line intervention instead of surgery for most tumor locations requiring treatment.

Ogsiveo (nirogacestat) is not approved for the treatment of any other indication in the United States, or for any indication in any other jurisdiction by any other health authority.

SpringWorks is also evaluating nirogacestat as a potential treatment for patients with ovarian granulosa cell tumors and for patients with multiple myeloma as part of several B-cell maturation agent (BCMA) combination therapy regimens in collaboration with leaders in industry and academia.

SpringWorks expects to file a Marketing Authorization Application for Ogsiveo in desmoid tumors with the European Medicines Agency in the first half of 2024.

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Botanical-Be is voluntarily recalling all lots of Kuka Flex Forte Capsules, Artri King, Capsules, and Reumo Flex Capsules to the consumer level. FDA analysis has found the Kuka Flex Forte Capsules, Artri King Capsules, and Reumo Flex Capsules, to be tainted with Diclofenac. Diclofenac is an approved non-steroidal anti-inflammatory drug (NSAID), however, the presence of Diclofenac in Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses. To date, Botanical-Be has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and are packaged as followed:

• Artri King distributed in the bottles with 100 capsules.
• Kuka Flex distributed in the bottles with 30 capsules.
• Reumo Flex distributed in the boxes with 30 capsules.

The affected product lots include the following lot numbers and expirations: Artri King lot 35421, with an expiration date of December 19, 2025; Kuka Flex Forte; all lots with an expiration date of December 12, 2024, and UPC code 0736640810265; Reumo Flex; all lots with an expiration date of October 20, 2024.

These products were distributed nationwide via the internet. Botanical-Be is notifying its customers via email and is arranging for the return of all recalled products.

Consumers in possession of these products should cease usage immediately and return them to the place of purchase.

For any queries related to this recall, consumers can contact Botanical-Be by phone at (915) 412-6237 or by e-mail at botanical.be@gmail.com on Monday to Friday from 8:00 am to 5:pm, Mountain standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

(BeneCard does not carry the noted manufactured drugs)

FDA Approves Maxigesic® IV to be Marketed in the U.S. as Combogesic® IV (acetaminophen and ibuprofen) for the Management of Pain

October 18, 2023 – Hyloris Pharmaceuticals SA), today announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.

The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.

Distribution of Combogesic® IV in U.S. hospitals should start in early 2024.

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Medically reviewed by Carmen Pope, BPharm.
By Elana Gotkine HealthDay Reporte

For patients undergoing open lumbar laminectomy, ultrasound-guided bilateral erector spinae plane blocks (ESPBs) combined with multimodal analgesia reduce opioid consumption, according to a study recently published in the European Spine Journal.

Jesse W. Stewart, M.D., from UT Southwestern Medical Center in Dallas, and colleagues compared the analgesic effects of preoperative, bilateral, ultrasound-guided ESPBs combined with standardized multimodal analgesia with multimodal analgesia alone (25 patients in each group) among patients undergoing one or two level open lumbar laminectomy.

The researchers found that with ESPBs, opioid requirements at 24 hours were significantly lower (31.9 ± 12.3 versus 61.2 ± 29.9 mg oral opioid equivalents). In the post-anesthesia care unit (PACU) and through postoperative day two, pain scores were significantly lower with ESPBs. Fewer patients in the ESPB group versus the non-ESPB group received postoperative antiemetic therapy (12 versus 48 percent). In addition, significantly shorter PACU duration was seen with ESPBs (49.7 ± 9.5 versus 79.9 ± 24.6 minutes).

“These findings suggest that ESPBs can play a major role in an opioid-sparing recovery plan that utilizes a multimodal pain management approach, not only in spine surgery but potentially for other types of surgery as well,” Stewart said in a statement

Medically reviewed by Carmen Pope, BPharm

By Elana Gotkine HealthDay Reporter

Earlier onset of atrial fibrillation (AF) is associated with increased risk of developing all-cause dementia, vascular dementia (VD), and Alzheimer disease (AD), according to a study published online Nov. 8 in JAMA Network Open.

Wenya Zhang, from the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing, and colleagues conducted a population-based cohort study using data from the U.K. Biobank to examine whether age at AF diagnosis is associated with risk of incident dementia and its subtypes. The main analysis included 433,746 participants.

The researchers found that compared to individuals without AF, the 30,601 with AF had increased risk of developing all-cause dementia and VD (adjusted hazard ratios, 1.42 and 2.06, respectively), but not AD. Younger age at AF onset was associated with increased risks of developing all-cause dementia, AD, and VD (adjusted hazard ratio per 10-year decrease, 1.23, 1.27, and 1.35, respectively). For developing all cause dementia, the highest hazard ratio was seen for individuals with AF diagnosed before age 65 years, followed by AF diagnosed at age 65 to 74 years (adjusted hazard ratios, 1.82 and 1.47, respectively) after propensity-score matching; the hazard ratio for AF diagnosed at ≥75 years was not significant. Results were similar for AD and VD.

“The quantitative manifestation of the association between AF onset age and incident dementia highlights the importance of monitoring cognitive function among AF patients, especially those younger than 65 years at diagnosis,” the authors write.

The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.

The Moderna COVID-19 Vaccine (2023-2024 Formula) is authorized for use in individuals 6 months through 11 years of age.

Summary of the Issue

FDA has become aware that some healthcare providers may not recognize that the single dose vial of Moderna COVID-19 Vaccine (2023-2024 Formula) for use in individuals 6 months through 11 years of age contains notably more than 0.25 mL of the vaccine. Some healthcare providers may be withdrawing the entire contents of the vial to administer to an individual. However, the volume of a single dose of Moderna COVID-19 Vaccine (2023-2024 Formula) is only 0.25mL.

Information for Healthcare Providers

We are advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient. To provide clarification, the Dosage and Administration section of the Fact Sheet for Healthcare Providers Administering Vaccine has been revised to further clarify that 0.25mL should be withdrawn from the vial and that the vial and any excess volume should then be discarded.

Healthcare providers, parents and caregivers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at ocod@fda.hhs.gov.