Antithrombin III(Grifols SA)

MONDAY, Jan. 8, 2024 -- Applesauce fruit puree pouches under recall and investigation for toxic lead levels may also contain another toxin, chromium, according to an update released Friday by the U.S. Food and Drug Administration (FDA). The products under recall are WanaBana, Weis and Schnucks brand cinnamon-flavored applesauce pouches. All were made by AustroFoods at a facility in Ecuador that is currently under FDA inspection. High lead levels appear tied to cinnamon used in the applesauce that was supplied by another company, Negasmart, the FDA said. At least 287 confirmed, probable and suspect cases of lead poisoning linked to tainted fruit puree pouches have now been reported in 37 states, according to the latest update from the U.S. Centers for Disease Control and Prevention (CDC). Now chromium has emerged as another possible toxin. "After additional analysis of both recalled cinnamon apple products and the cinnamon collected from the manufacturer in Ecuador, FDA has determined that, in addition to lead, the cinnamon and recalled products also contained a high level of chromium," the FDA announced in its Friday update. Chromium is a naturally occurring element that comes in various forms. According to the CDC, chromium III is an essential nutrient, while chromium VI is known to cause cancer. At this time, however, FDA "was not able to definitively determine the form of chromium in the cinnamon apple puree sample," the agency said. In any case, "people who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium and should inform their healthcare provider so they can monitor health and provide supportive care, as needed," the FDA said. Ongoing investigation Meanwhile, investigation into U.S. lead poisoning cases tied to the applesauce pouches continues. The median age for cases in the investigation "is nearly 2 years old," a CDC spokesperson told CBS News , though reports have come in for children as old as 9. Federal officials have urged state health departments to seek out cases of lead poisoning, which could be missed if children who ate lead-tainted applesauce don't get blood tests from their doctor for the toxic metal. AustroFoods said last month that it will reimburse customers up to $150 for lead tests. In early December, FDA said the tainted fruit puree pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards. Tests conducted at an Ecuadorean facility run by Austrofoods found that cinnamon supplied to the plant by another company, Negasmart, contained "extremely high levels of lead contamination, 5110 parts per million (ppm) and 2270 ppm," the FDA said in its update. To put that into context, an international body charged with setting lead limits in bark-sourced spices such as cinnamon "is considering adopting a maximum level of 2.5 ppm for lead in bark spices," the FDA said. 'Intentional act' Speaking to Politico in early December, an FDA source said the cinnamon used in the recalled applesauce may have been deliberately tainted. "We’re still in the midst of our investigation," Jim Jones , the FDA's deputy commissioner for human foods, told Politico . "But so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.” “My instinct is they didn’t think this product was going to end up in a country with a robust regulatory process,” Jones said. “They thought it was going to end up in places that did not have the ability to detect something like this.” According to Politico , the FDA suspects the deliberate adulteration of cinnamon included in the applesauce products was "economically motivated." The FDA said Negasmart, the source of the tainted cinnamon, is now operating under an “Ecuadorian administrative sanctions process.” Jones told Politico that food adulteration outside the United States “is always going to be tricky to absolutely stop, if somebody has intent to purposefully do something like this.” An FDA spokesperson also told Politico : “We have limited authority over foreign ingredient suppliers that do not directly ship product to the U.S. because their food undergoes further manufacturing/processing prior to export.” Still, he said, “we’re going to chase that data and find whoever was responsible and hold them accountable." Advice to parents So far, sample analysis of WanaBana, Weis and Schnucks fruit puree pouches that do not contain cinnamon and are not part of the recall have not shown elevated levels of lead. In its initial alert on the recall issued in late October, the FDA said four children in North Carolina were the first to be found to have high levels of lead in their blood that was linked to the WanaBana products. By law, food manufacturers have a responsibility to prevent chemical hazards when needed, the FDA noted. This includes measures to lower or eliminate the presence of lead in their products. The FDA has warned families not to eat or serve these products and encourages them to throw out the pouches or return them to the store where they were purchased for a refund. Caregivers should take any children who may have eaten these products to have blood tests to check for lead exposure, the CDC added. Lead is toxic to humans, particularly children, and there is no safe level of exposure, the CDC says. Exposure can cause developmental delays in children. Initial symptoms of lead poisoning may include head, stomach and muscle aches, vomiting, anemia, irritability, fatigue and weight loss. Sources U.S. Centers for Disease Control and Prevention, health alert, Dec. 29, 2023 U.S. Food and Drug Administration, health alerts, Jan. 5, 2024, Dec. 26 and Nov. 17, 2023 Politico CBS News Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

LACHEN, Switzerland, June 6, 2023 /PRNewswire/ -- Octapharma to present new clinical and scientific findings for wilate®, Nuwiq®, octaplex® and atenativ® at the upcoming ISTH 2023 Congress New data and clinical study developments will be presented in nine posters and during two Supported Symposia The most recent developments from Octapharma's Haematology and Critical Care portfolios will be presented at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) on June 24–28, 2023, in Montréal, Canada. The data will be featured in nine poster presentations and two Supported Symposia during this key international meeting. Octapharma is a proud Silver Supporter of the ISTH 2023 Congress. There will also be a promotional booth focusing on modern approaches to bleeding and coagulation management. People with inherited bleeding disorders, such as haemophilia A and von Willebrand disease, are at risk of recurrent and prolonged bleeds placing a heavy burden on patients' lives. In addition to the risk of potentially life-threatening bleeds, increased bleeding is associated with long-term consequences that severely impair patients' quality of life. Patients with a deficiency of the prothrombin complex of coagulation factors are also at increased risk of bleeding. Such deficiencies may be inherited but can also be acquired and may be induced by the use of vitamin K antagonists (VKA) for anticoagulation therapy. During urgent surgery, rapid correction of the deficiency is required and can be achieved through the use of four-factor prothrombin complex concentrates (4F-PCC). 4F-PCC can also be used to control major bleeding associated with the use of direct oral anticoagulant (DOAC) therapy in patients with factor Xa inhibitors. The presentations at ISTH 2023 reflect Octapharma's long-term commitment to improving patient care and addressing unmet clinical needs. "We are proud to showcase our new data and provide updates of studies from across Octapharma's haematology and critical care portfolios at ISTH 2023," said Olaf Walter, Board Member at Octapharma. "Despite advances in the field, people with bleeding and coagulation disorders still face considerable challenges surrounding bleed management. At Octapharma, we strive to address such challenges head-on with the goal to improve the day-to-day lives of patients." Poster Presentations The WIL-31 study investigated the efficacy and safety of prophylaxis with wilate® in patients with von Willebrand disease (VWD) of any gender with VWD type 1, type 2 (except 2N) or type 3. The results of the study show that wilate® prophylaxis is highly effective at reducing the number of bleeds in children and adults, and provides compelling evidence to support the use of regular prophylaxis in patients with severe VWD. Further data on the efficacy and safety of wilate® prophylaxis is being collected in the WIL-33 study in children under six years of age. The goals and design of this study will be presented. Prophylaxis is already the standard of care for people with haemophilia A. The results of an indirect comparison show that fewer patients experienced bleeds when receiving personalised prophylaxis with Nuwiq® rather than prophylaxis with a comparator factor VIII (FVIII) product. New data exploring differences in the binding of different recombinant FVIII products to platelets in vitro will be shared in a separate poster. Although haemophilia A mainly affects males, female carriers may also have reduced levels of FVIII and be at increased risk of bleeding, especially during traumatic events such as surgery. Data from a retrospective case series of female haemophilia A carriers who were prescribed Nuwiq® during surgery at the Bonn Haemophilia Centre will provide an insight into the effective treatment of females. MOTIVATE is an ongoing, international investigator-initiated study made possible through funding from Octapharma AG, evaluating the management of haemophilia A patients with inhibitors. The Coordinating investigators, Drs Carmen Escuriola Ettingshausen and Robert F. Sidonio Jr., will provide an update on the study status as a poster at the Congress. The LEX-210 study will evaluate the haemostatic efficacy of octaplex® in patients with acute major bleeding receiving factor Xa inhibitors. As anti-factor Xa (anti-Xa) activity levels will be measured in these patients, the correlation between heparin-calibrated and specific factor Xa inhibitor assays has been analysed and will be presented. The results from the first head-to-head, phase 3, randomised, controlled trial (LEX-209) comparing two 4F-PCCs in patients on VKA anticoagulation who need urgent surgery will be presented, with a focus on dosing and haemostatic efficacy results. The results show that octaplex® was non-inferior to control 4F-PCC for rapid vitamin K antagonist reversal in patients undergoing urgent surgeries with significant bleeding risk. The posters will be presented at the following times: Sunday June 25, 18:30–19:30 ET PB0163. Differential binding of recombinant FVIII products to platelets, and impact of FVIII on VWF expression and platelet contractility in vitro. Presenting author: Viola Vogel. PB0235. Phase 3 study of the efficacy, pharmacokinetics, immunogenicity and safety of von Willebrand factor/factor VIII concentrate in patients with severe von Willebrand disease under 6 years of age. Presenting author: Akshat Jain. PB0238. Prospective, phase III study of the efficacy, safety, and pharmacokinetics of a human antithrombin III concentrate in congenital antithrombin deficiency during surgery or childbirth. Presenting author: Craig Kessler. Monday June 26, 18:30–19:30 ET PB0840. Efficacy of prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate in patients with von Willebrand disease: Subgroup analysis by age and VWD type. Presenting Author: Robert F. Sidonio Jr. PB0681. German experience with simoctocog alfa during surgery in female haemophilia A carriers. Presenting author: Natascha Marquart. PB0584. Using heparin-calibrated assays to assess anti-factor Xa activity of factor Xa inhibitors (FXaI): a literature correlation analysis. Presenting author: Ravindra Sarode. PB1032. Four-factor prothrombin complex concentrates for vitamin K antagonist reversal before urgent surgery: dosing and hemostatic efficacy in a double-blind randomized study. Presenting author: Ravindra Sarode. Tuesday June 27, 18:30–19:30 ET PB1261. Matching adjusted indirect comparisons between personalized prophylaxis with simoctocog alfa versus standard prophylaxis with turoctocog alfa in adults with severe haemophilia A. Presenting author: Fernando F. Corrales-Medina. PB1288. Immune tolerance induction (ITI) strategies in haemophilia A patients with inhibitors – data from the MOTIVATE study. Presenting author: Carmen Escuriola Ettingshausen. Wednesday June 28, 13:00–14:00 ET PO11. Impact of simoctocog alfa prophylaxis on bleeding and joint health in Spanish patients with severe haemophilia A. Presenting author: María Teresa Alvarez-Román. Supported Symposia New clinical and scientific data, as well as updates on ongoing and new studies, will be shared during two Supported Symposia during the Congress. Final Results of the WIL-31 Study – A New Treatment Standard for von Willebrand Disease Patients with Severe Bleeding? Monday June 26, 13:15–14:30 ET, Room 511 Chair: Alok Srivastava, Christian Medical College, Vellore, India The symposium will focus on new data regarding the use of wilate® prophylaxis in children and adults to improve the lives of people with VWD. Topics presented will include the importance of prophylaxis, including current guidelines on the management of VWD and how to identify patients who may benefit from prophylactic treatment. Key learnings from the WIL-31 VWD prophylaxis study will be shared and case presentations of select WIL-31 patient cases from across the globe will be discussed. Bringing Together Two Worlds – Scientific and Clinical Insights for All-Round Bleed Protection in Haemophilia A Tuesday June 27, 13:15–14:30 ET, Room 511 Chair: Davide Matino, McMaster University, Hamilton, Ontario, Canada Octapharma's symposium on haemophilia A this year is dedicated to both, scientists and clinicians. The speakers will present data from the NuPreviq trial and the matching adjusted indirect comparisons (MAIC) analyses of Nuwiq® vs extended half-life (EHL) products as well as introduce the PROVE study. Topics discussed during this symposium will also include the role of platelets in FVIII binding, impact of prophylaxis on microRNA expression (biomarkers of joint and bone health) and how to utilise the power of RNASeq to understand inhibitor development. Both symposia will be open to congress participants in Montréal and will be streamed live for participants not attending the Congress. The opportunity to ask questions will be available at both symposia. Larisa Belyanskaya, Head of IBU Haematology at Octapharma commented: "We are delighted to showcase new data from WIL-31, which supports the importance of prophylaxis in people with von Willebrand disease, and to discuss scientific and clinical questions that need to be address to advance the management of people with haemophilia A." About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein[1]. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor[1]. Nuwiq® treatment has been assessed in nine[1-3] completed clinical trials which included 201 previously treated patients (190 individuals)[1] and 108 previously untreated patients[2] with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations[4]. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups[4]. About wilate ® wilate® is a high-purity human von Willebrand factor/factor VIII (VWF/FVIII) concentrate, that undergoes two virus inactivation steps during its production[5]. No albumin is added as a stabiliser[5]. The purification processes result in a 1:1 ratio of VWF to FVIII that is similar to normal plasma[5]. wilate® contains a VWF triplet structure and content of large high molecular weight multimers similar to normal human plasma[5]. wilate® is exclusively derived from large pools of human plasma collected in approved plasma donation centres[6]. wilate® is available in 500 IU and 1,000 IU presentations. wilate® is indicated for the prevention and treatment of haemorrhage or surgical bleeding in von Willebrand disease (VWD), when desmopressin (DDAVP) alone is ineffective or contra-indicated, and for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)[6]. About octaplex® octaplex® is a human four factor prothrombin complex concentrate (4F-PCC) containing Factors II, VII, IX and X, as well as inhibitor protein C and its cofactor protein S. octaplex® is indicated for the treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. It can also be used in the treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available. octaplex® is presented in vials containing 500 IU and 1000 IU of human prothrombin complex. The total protein content per vial is 260–820 mg (500 IU vial)/ 520–1640 mg (1000 IU vial). The specific activity of the product is ≥ 0.6 IU/mg proteins, expressed as factor IX activity. Do not store above 25°C, do not freeze. Store in the original package in order to protect from light. The product shelf life is three years.[7] About atenativ® atenativ® is a human antithrombin III concentrate (AT III), which is presented in vials containing 500 IU and 1000 IU of human antithrombin III as lyophilised powder for infusion. After reconstitution with 10 mL water for injection (WFI), the solution provides 50 IU/mL or 100 IU/mL of human antithrombin III. Store in the refrigerator (2-8 °C) Keep the vials in the outer carton in order to protect from light. The shelf life is three years. It has been indicated for treatment of patients with congenital and acquired antithrombin deficiency including prophylaxis for the prevention of deep vein thrombosis and thromboembolism in clinical risk situations (especially in surgery, pregnancy and childbirth), in combination with heparin, if indicated, as well as prevention of the progression of deep venous thrombosis and thromboembolism associated with heparin as indicated.[8] atenativ® is currently not registered in Canada. 1. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. 2. Liesner RJ et al. Thromb Haemost 2021; 121:1400-8. 3. Octapharma AG; Data on file. 4. Nuwiq® Summary of Product Characteristics. 5. Stadler M et al. Biologicals 2006; 34:281-8. 6. wilate® Summary of Product Characteristics. 7. octaplex® Summary of Product Characteristics. 8. atenativ® Summary of Product Characteristics. Octapharma press releases are specifically for health specialist/medical media and are not for consumer press. Logo - SOURCE Octapharma AG