- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
June 6, 2023Super Lawyers Names Five Attorneys to “Southern California Rising Stars” List
-
June 1, 2023Chambers USA Recognizes Five Robins Kaplan Practice Groups and 17 Lawyers in 2023 Guide
-
May 2023Robins Kaplan LLP Celebrates 85 Years
-
June 9, 2023LGBTQ Legal Services: Transgender Name Change Clinic
-
June 13, 20232023 Probate and Trust Law Section Conference
-
June 14, 2023Leading Through Uncertainty
-
May 2023Raoul Shah: Keeping Humanity and Compassion Close
-
May 18, 2023NFT Trademark Defense Comes Down To Licensing Terms
-
April 20, 2023Drafting Subsequent Agreements to Avoid Arbitrability Litigation
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Injectafer Linked to Severe Hypophosphatemia
July 22, 2020
The pharmaceutical drug Injectafer (generic name: ferric carboxymaltose), an iron carbohydrate complex used to treat iron deficiency anemia, has been linked to severe hypophosphatemia (HPP) – a dangerously low level of phosphorus in the blood that can cause life-threatening complications.
Severe Hypophosphatemia Can Be Life-Threatening
Iron deficiency anemia occurs when the body lacks sufficient iron. Injectafer is an iron deficiency anemia treatment used in adult patients who have an intolerance or unsatisfactory response to oral iron. The drug is injected intravenously by a healthcare professional, often in two doses, approximately seven days apart.1
Injectafer has been shown to dramatically reduce the amount of phosphate (phosphorus) in the body, leading to severe hypophosphatemia. Symptoms of severe HPP include extreme fatigue, muscle weakness and confusion, and left untreated, severe HPP can cause seizures, respiratory failure, heart failure, rhabdomyolysis, and osteomalacia.2 Complications involving severe HPP can even lead to coma and death.3
Studies Show Injectafer Increases Risk of Severe Hypophosphatemia
Clinical studies involving Injectafer overwhelmingly point to Injectafer’s propensity to cause severe HPP at rates drastically higher than its competitor iron supplements.
For example, a study published in February 2020 found that 73-74% of those given Injectafer developed hypophosphatemia (measured as a serum phosphate level of 2.0 mg/dL or less), while only 8% of those given another iron infusion drug called Monoferric developed hypophosphatemia.4 Severe hypophosphatemia (measured as a serum phosphate level of 1.0 mg/dL or less) occurred in 11.3% of those treated with Injectafer, but did not develop in those treated with Monoferric.5
Another study published in 2018 reported that over half of those treated with Injectafer developed severe hypophosphatemia (serum phosphate measured at less than 2.0 mg/dl ) and 10% developed extreme hypophosphatemia (serum phosphate measured at less than 1.3 mg/dl), while less than 1% of those treated with Feraheme developed severe hypophosphatemia and none developed extreme hypophosphatemia.6
Injectafer Label Changed in February 2020 to Warn of “Symptomatic Hypophosphatemia”
Despite all of the medical studies demonstrating the disproportionate rates of severe and extreme hypophosphatemia among Injectafer users, the manufacturers of Injectafer failed to adequately warn of the dangerous nature of Injectafer. Prior to February 19, 2020, the label did not mention severe or symptomatic hypophosphatemia as a potential risk of using the drug. In February 2020, the label was updated to include a warning for “Symptomatic Hypophosphatemia.”7 The label still does not address the severity or the high rate of hypophosphatemia that Injectafer can cause.
We Will Investigate Your Case for Free
Robins Kaplan LLP is investigating cases in which individuals have been treated with Injectafer and subsequently suffered serious side effects related to severe HPP. If you or someone you know has suffered from these side effects, please call us at 1.800.553.9910 or contact us here.
1 See https://injectaferhcp.com/.
2 Imel EA, Econs MJ. Approach to the hypophosphatemic patient. J Clin Endocrinol Metab. 2012;97(3):696‐706. doi:10.1210/jc.2011-1319.
3 Wang et al., Impact of hypophosphatemia on outcome of patients in intensive care unit: a retrospective cohort study. BMC Anesthesiol. 2019 May 24;19(1):86. doi: 10.1186/s12871-019-0746-2.
4 Wolf M, et al., Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials, JAMA. 2020; 323(5)423-443 (Feb. 2020).
5 Id.
6 Wolf M, et al. Randomized trial of intravenous iron-induced hypophosphatemia. JCI Insight. 2018;3(23) (Dec. 2018).
7 Injectafer [package insert]. Shirley, NY: American Regent, Inc. February 2020.
The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.
Related Professionals
Kate E. Jaycox
Partner
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.