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FDA Warning on OTC Sodium Phosphate Products Illustrates Inconsistency by the Agency

The U.S. Food and Drug Administration issued a warning on Jan. 8, 2014, about possible harm from exceeding the recommended dose of over-the counter drugs to treat constipation.  According to the FDA safety announcement, a number of over-the-counter (OTC) laxatives have been found to have serious and potentially fatal side effects when warnings on the "Drug Facts" label are not followed or when there are certain coexisting health conditions.  In other words, you should read the label carefully if you're taking a laxative and not exceed the maximum dose.

While consumers might think the federal agency is taking strong action to protect the public, in fact this recent warning illustrates how the FDA can act inconsistently.

Drug recall lawyer Jeffrey D. DeCarlo - who has been successfully litigating cases across the country against manufacturers of sodium phosphate bowel FDA Warningcleansing products since 2005 - points out that the FDA has approved a prescription drug (OsmoPrep) that contains twice the dose as these OTC products!

Like the OTC sodium phosphate drugs, the prescription bowel cleansers, used prior to colonoscopy or drug injury other procedures, were linked to a serious form of kidney damage.  According to the new FDA safety announcement, using more than one dose in 24 hours of over-the-counter sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. These sodium phosphate laxatives are sold under the brand name Fleet and are also sold as store and generic brands.

Why the FDA Needs to Be More Consistent

Attorney DeCarlo expresses alarm about the FDA's inconsistency when it comes to alerting the public as to the risks of using sodium phosphate products - and he points out the agency's actions can have serious ramifications.  On the one hand, the FDA is saying in this new warning:  don't exceed the recommended dose for these over-the-counter products, as it can be seriously harmful to your health.  But, on the other hand, the agency has also approved the prescription drug OsmoPrep that contains twice the dose as these OTC products.

The fact that the prescription of sodium phosphate is obtained through a physician is not going to help or stop someone from having an adverse reaction due to amounts of sodium phosphate that are now known to be harmful. The FDA is not acting consistently, and consumers will likely continue to suffer serious harm.

Why does this happen?  For one, the FDA has been systematically underfunded for decades.  In a previous post, we explored the problem of institutional corruption in the pharmaceutical industry.  Changes are needed, but may be difficult to achieve politically, because the pharmaceutical industry has paid a lot of money to shape outcomes of legislation and exert influence over congressmen.

That's one reason why it's important to have a strong legal advocate on your side if you or a loved one was injured by a sodium phosphate product or some other dangerous drug.  You need to level the playing field with a powerful and experienced attorney.  The FDA has received 54 reports of side effects, including 13 deaths, linked to OTC sodium phosphate laxatives.  Serious side effects include dehydration and/or abnormal levels of electrolytes in the blood that can lead to kidney damage and sometimes death.  Don't delay if you or a loved one is experiencing any side effects of sodium phosphate products.

Jeffrey D. DeCarlo is proud of the work he has done to help consumers injured after using sodium phosphate products.  As part of a class action lawsuit, Jeffrey D. DeCarlo played a principal role in developing the national settlement criteria for the settlement of more than 350 claims in the Fleet Phospho-soda laxative multi-district legislation.

If you or a loved one was injured or suffered adverse side effects after using an OTC sodium phosphate drug or a prescription product, contact the Law Office of Jeffrey D. DeCarlo, P.A., today at 877-572-0065 for a free evaluation.

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