Impaired Renal Function From Oral Phosphates Leads FDA To Issue Recall
After the recent Food and Drug Administration Fleet Phospho-Soda recall, many consumers have expressed concern regarding the medication and its risk for serious medical injury. The products pulled off of the market included many popular over-the-counter medications typically used for bowel prep before colonoscopy treatments, and for years were considered both safe and effective to use. However, in light of troubling reports, the warning made clear the connection between the drug and the risk involved. In addition, all prescription versions of the drug now feature “black box” warnings to more accurately reflect the risk of injury when taking it in high doses, or in a manner inconsistent with doctor’s orders. The FDA explained, “Though rare, these are serious adverse events associated with the use of oral sodium phosphates - both prescription and over-the-counter products. In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury.” Prior to the agency's action, a series of side effects had been well-documented in those using the medicine, including rectal bleeding, lack of bowel movement after use, seizures, sores and/or ulcers around the rectum, drowsiness, mood changes, loss of appetite, nausea, vomiting, uneven heart rate, limited or lacking urination, swelling, weight gain, and shortness of breath. The primary concern has to do with a condition called phosphate nephropathy, a disease that presents when crystals form in the renal tubules and create a blockage. Ultimately, the blockage can lead to renal failure. While some patients have recovered from the disease without extensive medical intervention, some experienced injury severe enough to require transplant or dialysis; the conditions have also been linked to fatalities. If phosphate nephropathy is not treated immediately the risk of fatality is markedly higher. A positive diagnosis is difficult, as it requires a complete biopsy. Consumers and patients affected typically experience symptoms within a few hours or days of taking the medication. Common signs of the disease include: - Bloating and water retention
- Limited or lacking urination
If a patient suspects they may be experiencing renal failure, or are exhibiting symptoms of the disease, it is essential that they seek medical help. The risk of death is extremely high without medical intervention. Additionally, many common medications may interact seriously withPhospho Soda Bowel Prep and can aggravate the possible complications, including narcotics, diuretics, NSAIDs, antibiotics, antidepressants, anti-nausea medications, anti-psychotics, blood pressure medications, and some common migraine drugs. These can raise the risk of more serious complications. In February of 2009, three women came forward as part of a product liability legal action. All three women purchased the over-the-counter drug and took high doses as preparation for colonoscopies. The suit claims that the parent company did not alert consumers to the risks associated with use of the drug, nor did they test the product thoroughly before releasing it to the general public. Attorneys have been working with these women to resolve the case, and hopefully settle damages and compensation. The suit could provide precedent for many others who used the product, which had never been tested or approved by the Food and Drug Administration. Many individuals who have taken the medication are looking to file a liability lawsuit, seeking compensation for medical bills, lost wages, or general pain and suffering. Working with a seasoned lawyer means you have access to past, pending, and current claims. Using a directory like LegalTube will help you find the attorney that is most appropriate for your needs.
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