Overview
Have you developed a zinc-related copper deficiency or myeloneuropathy after taking Bausch and Lomb PreserVision®AREDS2 Formula Eye Vitamin & Mineral Supplements?
Our Lawyers are Ready to Assist You
Robins Kaplan LLP is investigating reports of serious injuries related to high levels of zinc in PreserVision which may lead to copper deficiencies and myeloneuropathy.
Myeloneuropathy, commonly known as ‘swayback’, is characterized by simultaneous damage of the tracts of the spinal cord and peripheral nerves in the lower limbs. It is a condition which features myelopathy-spinal cord disease and neuropathy-peripheral nerve disease. Myeloneuropathy can be caused by copper deficiencies1 due to overuse of zinc in supplements2. Clinical signs of myeloneuropathy include:
- Difficulty in walking and balance
- Weakness of lower limbs
- Ataxic gait
- Sensory manifestations in glove and stocking distribution.
- Hyperreflexia, spasticity, extensor plantar responses
- Bladder bowel disturbances
Why PreserVision®AREDS2 May Lead To Myeloneuropathy?
In 1992, The National Eye Institute (NEI) division of the National Institutes of Health (NIH) launched research studies in the pursuit of slowing the progression of age-related macular degeneration (ARMD). In these initial studies, the Age-Related Eye Disease Study (AREDS)3, high doses of antioxidant supplements (vitamins C, E and A), and high doses of zinc, along with moderately high doses of copper for mineral balance, were studied.
As part of the studies, Bausch and Lomb produced various supplement formulations used in the clinical trials. Bausch and Lomb was allowed to patent a specific formula, which they named PreserVision. The initial trial formula included 80 milligrams of zinc, which was found to be effective, although some nutritional experts recommend much lower daily doses of zinc. AREDS investigators followed participants for ten years and launched additional studies Age-Related Eye Disease Study 2 (AREDS2)4 in 2006. The AREDS2 study concluded that the vitamin A component, in the form of beta-carotene, appeared to increase the rate of lung cancer in former smokers.
To refine their formula, Bausch and Lomb obtained a second patent for PreserVision AREDS 2 in which vitamin A was removed and replaced by the carotenoids Lutein and Zeaxanthin. Copper was added to the second formula to reduce the risk of copper deficiency anemia associated with high levels of zinc intake. Copper deficiency due to zinc excess arises from an indirect interaction between the two metals in the intestine4. When exposed to excess dietary zinc, the absorptive duodenal cells upregulate metallothionene, a metal-binding ligand. It binds with both zinc and copper, but more strongly with copper. This bound up metal is then sloughed off into the intestinal lumen and carried away.
Because of this, an increase in oral copper intake is ineffective in restoring the zinc-copper balance in the presence of excess dietary zinc.5 The Recommended Dietary Allowance (RDA) for Zinc is 8 mg per day for women, and 11 mg day for men. The RDA for copper is 900 micrograms (mcg) per day.
The PreserVision AREDS 2 formula contains a total daily dose of 80 mg zinc, which is 727% of the Recommended Dietary Allowance of zinc, and 2 mg of copper; which is 222% of the Recommended Dietary Allowance of copper.
We Will Evaluate Your Case for Free
If you believe that you have been adversely affected by a zinc-related copper deficiency or have developed myeloneuropathy after taking Bausch and Lomb PreserVision®AREDS2 we may be able to help.
Contact our attorneys for a free case evaluation at 1.800.553.9910 or by completing our online contact form above.
About Our Mass Tort Attorneys
Our nationally recognized mass tort attorneys assist clients who are seriously injured by dangerous and defective products.
Robins Kaplan’s medical and pharmaceutical attorneys have the experience to take on big drug companies. Our team of attorneys, registered nurses, paralegals, and case assistants will thoroughly investigate your case, doing the following as needed:
- Upon commencement of legal representation, one of our attorneys, legal nurses, or paralegals will call you and discuss your relevant medical history and prescription drug use.
- We will order and review your medical and pharmaceutical records, and we will determine if you took a potentially harmful drug, and then evaluate whether that drug hurt you.
- Our pharmaceutical lawyers will compare the laws of your state with the timeline of events, including, key dates in your medical timeline and dates of certain acts or omissions by the medicine manufacturer, and we will plan the best litigation strategy for your case.
- We will investigate whether the drug manufacturer complied with FDA regulations and whether the manufacturer warned you about risks and side-effects associated with the drug.
Throughout the entire process, our legal team will keep you informed about your case.
Contact us for a free and confidential evaluation today. To get started, call 1.800.553.9910 or complete our online contact form above.
References:
1 See https://n.neurology.org/content/61/2/273 Neeraj Kumar, MD; John B. Gross, Jr., MD; and
J. Eric Ahlskog, PhD, MD Myelopathy due to copper deficiency. American Academy of Neurology Journal. July 21 2003.
2 See https://pubmed.ncbi.nlm.nih.gov/15834043/ Rowin J, Lewis SL. Copper deficiency myeloneuropathy and pancytopenia secondary to overuse of zinc supplementation. J Neurol Neursurg Psychiatry. 2005;76:750-51.
3 See https://www.nei.nih.gov/research/clinical-trials/age-related-eye-disease-studies-aredsareds2/about-areds-and-areds2#section-id-14213
4 See https://www.nei.nih.gov/research/clinical-trials/age-related-eye-disease-studies-aredsareds2/about-areds-and-areds2#section-id-14094
5 See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7146416/ Maria Maares and Hajo Haase. A Guide to Human Zinc Absorption: General Overview and Recent Advances of In Vitro Intestinal Models. MDPI, Basel, Switzerland. January 27 2020.
