Injectafer recall

Injectafer recall. for as little as. Manufacturer customer service or other non-safety recall campaigns. Accessed June 2019. Your VIN is a unique 17 character (including letters) serial number that can be found on your vehicle (the passenger side door sill, for example) or in your vehicle's documentation (like its registration). Class: Supportive Care Generic Name: ferric carboxymaltose (FER-ik kar-box-ee-MAWL-tose) injection Trade Name: Injectafer® For which conditions is this drug approved? Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: Who have intolerance to oral iron or have had unsatisfactory response to oral iron Who have non-dialysis dependent chronic kidney disease Injectafer lawsuits claim drug causes hypophosphatemia (HPP). See full list on drugwatch. And, a Class III is for drugs that are high levels of iron stored in your body --feeling weak or tired, joint pain, finger pain, stomach pain, weight loss, irregular heartbeats, fluttering in your chest. Avoid extravasation of Injectafer since brown discoloration of the extravasation site may be long lasting. Injectafer: NDC 0517-0650-01 (750 mg) NDC 0517-0602-01 (100 mg) Lot Number: Dose Administered: Total # of Vials Administered: I have administered Injectafer, as indicated above, for the above patient to treat iron deficiency anemia or iron deficiency in heart failure. The NDC code 0517-0602 is assigned by the FDA to the product Injectafer which is a human prescription drug product labeled by American Regent, Inc. redness of the face, neck, arms, and occasionally, upper chest. 7600 – Toll free 888. 1 In CONFIRM-HF (a trial specific to ID treatment in certain HF patients), the mean and median total dose was 1500 mg (with a dosing range of 500 mg-3500 mg iron). My patient Feb 12, 2020 · Injectafer, an intravenous medication used to treat adult iron deficiency anemia, is making headlines and not because of its efficacy. The dosage of Injectafer is expressed in mg of elemental iron. For Injectafer 1,000 mg, administer as a slow intravenous push over 15 minutes. Phone 703. According to an Injectafer lawsuit pending in the U. Obtain physician and. Dec 7, 2023 · • Injectafer 100 mg iron/2 mL single-dose vial: 00517-0602-xx • Injectafer 750 mg iron/15 mL single-dose vial: 00517-0650-xx • Injectafer 1,000 mg iron/20 mL single-dose vial: 00517-0620-xx VII. 5578 in Injectafer. 1 day ago · How to say injectafer in English? Pronunciation of injectafer with 1 audio pronunciation, 1 meaning and more for injectafer. These are not all the possible side effects of Injectafer. 7 million patients have been treated for iron deficiency anemia. News. Your doctor or nurse will monitor your response during and after your infusion for sign of an unusual or allergic reaction, usually for about 30 minutes. Despite these clinical findings, Luitpold released Injectafer in the US without adequate warnings, according to lawsuits. 7. If extravasation occurs, discontinue the Injectafer administration at that site. May 2023. It is also used to treat iron deficiency anemia in adults with chronic kidney disease Jul 18, 2023 · Injectafer Side Effects. Any unused drug remaining after injection must be discarded. Injectafer® has been approved in 83 For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course . Injectafer® has been studied in more than 40 clinical trials that included over 8,800 patients worldwide. $50†. A growing number of lawsuits accuse the manufacturers of Injectafer® of failing to warn about the risk of hypophosphatemia, a severe side effect involving dangerously low phosphate levels in the blood. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. 5, 1500) [1 to <12 years: 672 mg (range: 264, 1500), 12 to ≤ 17: 1500 mg (range: 0. The recall affected millions of manufactured devices. Pregnancy. The product's dosage form is injection, solution and is administered via intravenous form. Sep 15, 2023 · Application error: a client-side exception has occurred (see the browser console for more information). . Mail to. Multiple Exactech recalls have occurred in recent years. Mar 18, 2008 · 212 Carnegie Center, Suite 301, Princeton, NJ 08540, USA. 5 minutes. Feb 4, 2020 · Injectafer is an intravenous medication approved to treat adults with iron deficiency anemia who are unable to tolerate oral supplements. If Injectafer is administered by slow IV push, it may take about 7. Code Type Code Description Product Package Codes NDC 0517-0602-01 0517-0650-01 Injectafer 100 mg iron/2 mL single-use vial (individually boxed) Injectafer 750 mg iron/15 mL single-dose vial (individually boxed) Product-Specific Jan 1, 2015 · Injectafer Initiation meets the definition of medical necessity when ALL criteria are met: 1. Animal data . For patients weighing less than 50 kg (110 lb): Give Injectafer in two doses separated by at least 7 days. In the Injectafer pivotal trials for the treatment of IDA, a fixed-dose regimen of 1500 mg was used. You may report side effects to FDA at 1-800-FDA-1088. 13 g/dL for Injectafer ® vs. Injectafer (ferric carboxymaltose injection) was no better than a placebo in a double-blind study of patients with heart failure with reduced ejection fraction. Program and if you may be eligible. There are different types of recalls though, depending on the danger involved with the drug. *For iron deficiency anemia (IDA), one course of treatment is 2 doses of 750 mg separated by at least 7 days. Enter VIN here: Note: certain VINS will require the user to pick a Brand via radio button. For patients weighing less than 50 kg (110 lb), the recommended dosage is Injectafer 15 mg/kg body Nov 14, 2020 · Injectafer (also known as ferric carboxymaltose) is an intravenous medication used to treat iron deficiency anemia. The implants were designed for people who developed arthropathy after a rotator cuff tear. It usually takes 2-3 days for EOB to be approved. The product is distributed in a single Nov 23, 2020 · Injectafer can be provided as a slow undiluted intravenous push at a rate of about 100 mg per minute. References 1. , that resolve Basking Ridge, NJ and Shirley, NY – June 5, 2023: Daiichi Sankyo, Inc. Dec 16, 2021 · Injectafer was first approved by the FDA in 2013 for adults as a 1500 mg course of treatment, administered as two doses of 750 mg each separated by at least seven days. Each mL contains 50 mg iron as ferric carboxymaltose in water for injection. Give patient a copy of Upon receiving the form, Daiichi Sankyo Access Central the Patient Consent on will be able to assess patient page 3 eligibility for Injectafer support patient signatures on programs as well as conduct a page 1 benefits Injectafer ® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. Safety recalls conducted by small vehicle manufacturers, including some ultra-luxury brands and specialty applications. The active ingredient in Injectafer is ferric carboxymaltose, the inactive ingredients are: water for injection, sodium hydroxide or hydrochloric acid. Get information on open safety recalls and service campaigns released since 1999 for Toyota, Lexus and Scion vehicles intended for sale or sold in the U. This decision was made despite the Food and Drug Administration (FDA) first rejecting the drug in 2006. On January 15, 2020, Plaintiffs Maria and Anthony Munroe of Massachusetts filed a lawsuit against the makers and sellers of Injectafer. Injectafer may harm your unborn baby. S. This medication is used to treat "iron-poor" blood (iron deficiency anemia). Feb 14, 2022 · Injectafer is a medication administered into the vein via a single or double-dose injection, based on body weight. Nationally Recognized in Legal Community. , and involves inadequate body iron stores for normal red blood cell production. nervousness. 8. ABOUT INJECTAFER What should I tell my healthcare provider before receiving Injectafer? (cont´d) • Are pregnant or plan to become pregnant. , a Daiichi Sankyo Group company, today announced that they have reached settlement agreements with Mylan Laboratories Ltd. feeling of warmth. 0 Comments NHTSA's new search tool lets you enter a Vehicle Identification Number (VIN) to quickly learn if a specific vehicle has not been repaired as part of a safety recall in the last 15 years. , and Sandoz, Inc. Abbreviated New Drug Application (ANDA) disputes regarding Injectafer® (ferric carboxymaltose) have now been settled. After FDA approval of lorcaserin in 2012, the FDA mandated a large-scale study to Dec 5, 2023 · Chicago Personal Injury Lawyer Dangerous Drug Attorney. This led to a litigation, and excited for future results of our ongoing robust clinical program for Injectafer®. loss of appetite. Sep 19, 2023 · Injectafer is injected into a vein by a healthcare provider. 9% sodium chloride injection, USP, such that the concentration of the infusion is not less than 2 mg of iron per mL and administer over at least 15 minutes. 2. May 1, 2023 · 2. These radio buttons will appear conditionally on the VIN you choose. Injectafer consists of a shell made of a carbohydrate polymer called carboxymaltose that is tightly bound around an iron core. Injectafer ® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease. The present formula is a double-dose 1,500 mg regimen. Injectafer (ferric carboxymaltose) Venofer (iron sucrose) Oct 5, 2023 · Injectafer (ferric carboxymaltose) is an iron supplement that's given as an infusion through the vein. Plaintiffs say Injectafer’s makers failed to notify the public of the risk. Patients under 180 pounds usually just need one injection to correct the problem, while those over 180 need two, delivered seven days apart. Awarded The Best Lawyer in 2024 by U. Injectafer (ferric carboxymaltose) can also treat iron deficiency in certain adults with heart failure. If you or your health care provider prefer to use the slow drip infusion method, Injectafer is mixed with a sodium chloride solution that gradually enters the blood stream directly through a vein . Injectafer ® has been studied in more than 40 clinical trials that included over 8,800 patients worldwide. com recall notice. What is Injectafer (ferric carboxymaltose injection)? Injectafer is an intravenous (IV) iron replacement product that is used to treat iron deficiency anemia (IDA). IDA is a common complication for a variety of GI disease conditions. Gallen, Switzerland, and Shirley, N. Product: Injectafer® (ferric carboxymaltose injection) NDC No. Each mL of Injectafer contains 50 mg of elemental iron. dizziness. Monitor for extravasation. The company stated that the foam, when degraded, potentially releases toxic vapors and black particles into the masks of the users. Jun 29, 2021 · The Injectafer FDA label was updated in February 2020 with new information about severe hypophosphatemia (HPP) risks. It is usually given in 2 doses, 7 days apart, or 6 weeks apart for iron deficiency with mild to moderate heart failure. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Injectafer. Jun 21, 2021 · The FDA found clinical safety issues including an “unacceptable risk for death, serious adverse reactions, and clinically important hypophosphatemia,” court documents say. • Are breastfeeding or plan to breastfeed. 0. The new single-dose injection contains 1,000 mg. Y, 20 December 2021 – Vifor Pharma Group and its partner American Regent, Inc. Call your doctor for medical advice about side effects. The impact of dangerous drugs on patient health can be devastating, ranging from severe side Following the 2022 recall, there have not yet been any Exactech knee lawsuit payouts, so average settlement amounts have not been determined. Transfusion. Injectafer is available in 15 mL single-use vials. Common side effects may include Injectafer ® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease. Potentially long-lasting brown staining of skin near the injection site may occur if Injectafer leaks The most common adverse reactions (≥4%) were hypophosphatemia (13%), injection site reactions (8%), rash (8%), headache (5%), and vomiting (5%). Injectafer is a prescription iron replacement medicine administered only by or under the supervision of your healthcare provider. Over $400 Million worth of case results. Injectafer (ferric carboxymaltose injection), a drug used to treat iron deficiency anemia, can cause common side effects such as nausea, dizziness and pain or bruising at the injection site. A Class II recall is for drugs, which may cause temporary injuries or injuries that can be reversed through other medical treatment. Injectafer [package insert]. Onken JE, Bregman DB, Harrington RA, et al. According to Pittsburgh’s Hillman Medical Center, Injectafer side effects may include flushing, dizziness, nausea, dangerously high blood pressure and low phosphorus levels. In two randomized clinical studies [Studies 1 and 2], a total of 1775 patients were exposed to The most common side effects of Injectafer include nausea, high blood pressure, flushing, low levels of phosphorous in your blood, dizziness, vomiting, headache, an increase in certain liver enzymes, and pain or bruising at the injection site. The chemical structure is presented below: Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. Injectafer is available in 15 mL single-dose vials. You can search for all safety recalls initiated after March 15, 1994. Some GXL Liners in Novation, Acumatch and MCS hip replacement devices Safety recalls that are more than 15 years old (except where a manufacturer offers more coverage). 53 LR. This was a class I recall, which means there is a risk of serious bodily harm or death. April 2018. List of products in the National Drug Code with proprietary name injectafer. Administration of ferric carboxymaltose to rabbits during organogenesis caused adverse developmental outcomes including malformations and increased implantation loss at maternally toxic doses of ~12-23% of the human weekly dose of 750 mg (based on body surface area) Jul 1, 2019 · 1. However, prior lawsuits over recalled implants have resulted in knee replacement settlements that ranged between $50,000 and $250,000, depending on the extent of problems caused by the implant. No deaths or SAEs were reported. Give each dose as 15 mg/kg body weight for a total cumulative dose not to exceed 1500 mg of iron per course. If you or a loved one received an Injectafer treatment and then suffered from severe HPP, we will fight to be sure you receive fair compensation. This recall supersedes and expands NHTSA recall number 14V-593. Serious side effects include high blood pressure, allergic reactions and abnormally low phosphate, also known as hypophosphatemia. high blood pressure. Vehicles previously repaired under 14V-593 will need to have the new remedy performed. Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single dose treatment course. 92 Dec 20, 2020 · Injectafer is an iron supplement often prescribed to people suffering from iron deficiency anemia, also known as IDA. This information was last updated on May 29, 2024. In children: low levels of phosphate in your blood, injection site reactions, rash, headache, and vomiting. It is an injectable form of ferric carboxymaltose (FCM) and is introduced directly to the bloodstream. low levels of phosphorous in your blood. Did you develop hypophosphatemia or other serious side […] What is NDC 0517-0650-01? The NDC Packaged Code 0517-0650-01 is assigned to a package of 1 vial, single-dose in 1 box / 15 ml in 1 vial, single-dose of Injectafer, a human prescription drug labeled by American Regent, Inc. Injectafer should be used only if you have not responded well to treatment with oral iron, or if 2. Patient receives each dose. The FDA was recently forced to do this for a shoulder implant developed by Zimmer Biomet because there was a higher rate of fracture than stated on the label. Accessed November 2023. Iron-deficiency anemia is a condition in which there is a lower than normal number As of October 2020, the FDA has not yet issued an Injectafer recall or any warning to the public regarding the apparent danger of using the product. It treats iron-deficiency anemia in people who can't take iron supplements by mouth and in certain adults with chronic kidney disease (CKD). For eligible patients. Feraheme is a prescription medicine used to treat iron-deficiency anemia in adults with chronic kidney disease. Then, funds will be uploaded onto the virtual 16-digit debit card. A Class I recall is for drugs, which may cause serious adverse effects or death. In 2013, Injectafer was first approved for sale and use in the United States. The generic name of Injectafer is ferric carboxymaltose injection. Complete all required fields. These are not all of the possible side INDICATIONS. Enrollment is valid for 2 courses of treatment per 12-month period. D. ( 1) adult patients who have non-dialysis dependent chronic kidney disease. The safety of Injectafer was evaluated in adult patients with iron deficiency and heart failure in randomized controlled trials FAIR-HF (NCT00520780 INJECTAFER prescription and dosage sizes information for physicians and healthcare professionals. flushing. Fax it to 1-833-471-9988. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course. Note: Luitpold Pharmaceuticals is a wholly owned subsidiary of Daiichi Sankyo. Injectafer is intended for single-use only. It was designed to gradually release iron once inside your body, which may decrease the potential for some side effects and give you more iron in just 2 administrations. Additionally, Philips mentioned on September 1st, 2021 that they intend to either repair or replace affected Aug 9, 2019 · Injectafer (ferric carboxymaltose) was approved for intravenous use by the FDA in 2013. Member’s hemoglobin is below the laboratory’s lower limit of normal – recent (within 60 days of request) laboratory documentation must be provided 3. What should I tell my healthcare provider before receiving Injectafer? Before you receive Injectafer, tell your healthcare provider about all of your medical conditions, including Dec 15, 2014 · In these high-risk patients, two 750-mg doses of Injectafer ® increased hemoglobin more than five 200-mg doses of Venofer ®, with a change in hemoglobin of 1. Its structure is similar to naturally occurring ferritin, which is the body's Injectafer® (ferric carboxymaltose injection) is an iron replacement product indicated for. Shirley, NY; American Regent, Inc. 05/24/24. Iron deficiency anemia affects about 7. District Court, Eastern District of Pennsylvania, Katherine Crockett was forced to take a leave of absence from work when she developed severe Sep 2, 2021 · The most common side effects of Injectafer include: nausea. The Board of Pharmacy has received notice of the following product withdrawal. The FDA cited that using Injectafer could cause dangerously low blood phosphorous levels, which can trigger hypophosphatemia. Enter your license plate number plus the state it was issued in, or enter your 17-digit VIN number. Injectafer should be used only if you have not responded well to treatment with oral iron, or if you are intolerant to oral iron treatment. Assistance of up to $500 per dose. the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required. Patients with Iron Deficiency and Heart Failure. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position. Administer Injectafer intravenously, either as an undiluted slow intravenous push or by infusion. 2020-2022 Hyundai Palisade Recall . 538. For patients weighing less than 50 kg (110 lb), the recommended dosage is Each Injectafer infusion may take about 15 minutes. In some Oct 12, 2020 · According to the lawsuit, following the first infusion, Injectafer caused his phosphate levels to fall precipitously, resulting in severe and/or symptomatic hypophosphatemia. Injectafer is administered intravenously (into a vein) either as an undiluted slow intravenous push or by infusion over at least 15 minutes. Here is a timeline of Exactech recalls: June 2021. Legally Reviewed by: Jonathan Rosenfeld. A recall involving an international vehicle. Hospira Carpuject Recall Issued Due to Potential Leaks of Some Drug Products. confusion. 5 million people in the U. Data are insufficient to assess risk of major birth defects and miscarriage. and American Regent, Inc. , U. Food and Drug Administration (FDA) approved INJECTAFER ® (ferric carboxymaltose injection) for the treatment of iron deficiency in adult patients with heart failure categorized as New York Heart Association class II/III to improve Injectafer is a prescription iron replacement medicine administered only by or under the supervision of your healthcare provider. Jun 8, 2023 · Injectafer (ferric carboxymaltose injection) is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. It was sold by Eisai Inc, a drug manufacturer. Fax to 1-888-257-4673. 1 Shares. ” In the US, more than 1. ADVERSE REACTIONS (severe hypotension, shock including in the context . When administering Injectafer 500 or 750 mg as a slow intravenous push, give at the rate of approximately 100 mg (2 mL) per minute. Feb 11, 2024 · bone pain. headache. ( 1) Recalls, Market Withdrawals and Safety Alerts; Press Announcements; Warning Letters; Advisory Committees; En Español; Products. 1 Injectafer has been May 2, 2024 · The size of the Injectafer lawsuit settlements will be determined by how much HPP injured the plaintiff. 3 DOSAGE FORMS AND STRENGTHS The Injectafer Savings Program. The supplement, then, boosts the levels of iron in the body. Injectafer ® (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron, or adult patients who have non-dialysis dependent chronic kidney disease. The defendants in the case are Luitpold pharmaceuticals, Inc, American INDICATIONS. * The Injectafer Savings Program is only available for adults 18 years or older who are commercially insured. Territories, and Mexico using our quick and easy recall and campaign lookup below. Administer Injectafer intravenously, either as an undiluted slow intravenous push or by Dec 7, 2023 · Injectafer 100 mg iron/2 mL single-dose vial: 00517-0602-xx Injectafer 750 mg iron/15 mL single-dose vial: 00517-0650-xx Injectafer 1,000 mg iron/20 mL single-dose vial: 00517-0620-xx VII. Injectafer Savings Program 100 Passaic Ave, Suite 245 Fairfield, NJ 07004. Print the form. iron or have had unsatisfactory response to oral iron, and in adult patients with non-dialysis. Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH to 5 Jul 29, 2020 · 1. J. When administered via infusion, dilute up to 1,000 mg of iron in no more than 250 mL of sterile 0. Injectafer should be used only if you have not responded well to treatment with oral iron, or if Dec 21, 2021 · In the US, more than 1. Nov 19, 2020 · Injectafer Infusion Side Effects. The main ingredient of Injectafer, ferric carboxymaltose, is for adults (and now children Feb 21, 2024 · Belviq is a weight loss drug with the active ingredient lorcaserin. Severe hypophosphatemia (HPP) can cause serious health problems, including bone pain, seizures, and death. The average Injectafer lawsuit settlement amounts for cases involving Injectafer-induced HPP if the plaintiff experienced very severe or long-term health effects might be between $200,000 and $500,000. * The Injectafer Savings Program is only available for patients aged 1 year or older who are commercially insured. For further assistance, call Injectafer Savings Program help desk at 1-866-4-DSI-NOW (1-866-437-4669)(8:00 AM ET - 5:00 PM ET, Monday to Friday, except holidays). , a Daiichi Sankyo Group company, today announced that the U. pounding in the ears. Dec 20, 2021 · Abbreviated New Drug Application (ANDA) disputes regarding Injectafer® (ferric carboxymaltose) have now been settled; St. 5, 1500). OR. Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. The researchers offered several possible explanations for the unexpected result. 2 Preparation and Administration . Potential Long-Term Side Effects of Hypophosphatemia Resulting from Injectafer Use In the 24 hours following administration of Injectafer, laboratory assays may overestimate serum iron and . Shockingly, the government approved a new Injectafer single dosage formula in May 2021. The overall median total dose of Injectafer was 1500 mg (range: 0. It is often prescribed to treat anemia in people who have Injectafer is contraindicated in patients with hypersensitivity to Injectafer or any of its inactive components. 2 Preparation and Administration. Injectafer is injected into your vein to treat iron deficiency anemia in adults and children 1 year of age and older. Pharmacology, adverse reactions, warnings and side effects. Jun 11, 2023 · Injectafer is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. Indication for use is iron deficiency anemia 2. Reich & Binstock has a successful track record of taking on the pharmaceutical industry. The first lawsuits were filed in 2019, following studies in which Injectafer was linked to a possible risk of hypophosphatemia. Injectafer. Chaffin Luhana attorneys are experienced in helping clients recover damages from negligent manufacturers. Please call our Houston personal injury attorneys at 713-622-7271 or fill out the contact form below for a free consultation with an attorney about an Injectafer lawsuit. : 0517-0650-01. 2014 Feb;54(2):306 Ferric carboxymaltose (Injectafer) is a high-dose IV iron that was specifically and prospectively evaluated in patients with cancer. Feb 22, 2024 · Exactech Recall. transferrin bound iron by also measuring the iron in . A Jul 3, 2023 · Injectafer is a brand (trade) name for ferric carboxymaltose injection, which may be used for the treatment of iron deficiency anemia (IDA). Injectafer lawyers say the drug makers failed to warn the public of the risk. Injectafer ® has been approved in 83 countries since initial European Union (EU) approval in 2007 and is the most extensively studied intravenous iron. 838. However, these warnings remain insufficient and continue to provide misleading information, which fails to fully describe the serious and potentially life-threatening nature of Injectafer side effects that may be experienced Dec 20, 2021 · AD HOC ANNOUNCEMENT PURSUANT TO ART. In addition, some patients may experience an allergic reaction to the drug, including swelling of the face, tongue, or throat, a rash The most common side effects of Injectafer include: In adults: nausea, high blood pressure, flushing, injection site reactions, skin redness, low levels of phosphate in your blood, and dizziness. Injectafer lawsuits claim the iron replacement drug, also known as ferric carboxymaltose, causes hypophosphatemia (HPP) or low phosphate levels. December 5, 2023. Call today for a free case evaluation at 1-888-316-2311. dependent chronic kidney disease. Philips sent out a recall notice in June of 2021. May 11, 2023 · Is There a Recall for Injectafer? Despite research studies relating Injectafer with hypophosphatemia, the FDA is yet to order a recall for the drug. xo pm re gx oz wo oa gw ka tv