The FDA recently issued a warning regarding the use of over-the-counter laxatives manufactured by C.B. Fleet Company. According to the agency, these laxatives are causing severe kidney and heart damage, and potentially death, if more than one dose is taken within one day. Drug injury lawyers at Pintas & Mullins Law Firm remind consumers taking OTC laxatives to avoid this dangerous product.
Many consumers taking C.B. Fleet’s laxatives products have been hospitalized for dehydration and dangerously low electrolyte levels, with at least one suffering fatal kidney and heart injuries. As stated, these products are most likely to cause severe injury if more than one dose, or a larger-than-recommended dose, is taken within 24 hours.
Although the drugs warn consumers not to take more than one dose within 24 hours, C.B. Fleet failed to include certain age and health restrictions. The laxative labels failed to alert consumers that those over age 55 and patients with certain health conditions need to speak to a physician before taking the over-the-counter sodium phosphate drug. Consumers in those specific groups are at much higher risk of serious side effects.
Patients with the following conditions or taking the following medications need to consult a doctor before taking any type of sodium phosphate laxative:
¢ Colon inflammation ¢ Kidney dysfunction ¢ Patients taking aspirin ¢ Ibuprofen ¢ Other non-steroidal anti-inflammatory drugs ¢ Diuretics ¢ Angiotensin-converting enzyme inhibitors ¢ Angiotensin receptor blockers (such as for high blood pressure)
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It is important to note that some laxatives are sold under generic and store-brand labels (opposed to labels denoting C.B. Fleet). These products are sold both as oral tablets and as enemas. It is impossible for the FDA to know the true amount of serious incidents and deaths related to these products, however, because adverse events are not required to be reported to the government.
Mining the data it does have available, however, the FDA knows of at least 54 patients who were critically injured by sodium phosphate laxatives over the past few decades, including more than a dozen deaths. The actual number, as stated, is unknown.
Recalls and Lawsuits
In 2008, the FDA added a black box warning, the most severe alert, to two similar prescription laxatives, OsmoPrep and Visicol, manufactured by Salix. The warnings informed patients that the drugs could cause severe kidney damage. Two years later, C.B. Fleet was forced to pull one of its laxative products from the market, Phospho-soda, after the FDA asserted that such drugs were dangerous and should only be taken through prescription. Subsequent lawsuits were filed from the recall, resulting in a large settlement for about 600 consumers injured by the laxatives.
C.B. Fleet is well aware that its products are dangerous, however they still refuse to include specific warnings on their labels. This blatant disregard for safety should not be tolerated.Kidney injury lawyers at Pintas & Mullins Law Firm are here to help anyone seriously injured by a C.B. Fleet laxative. Our case reviews are completely free, and available for injured consumers nationwide.