Drug experts are warning patients about the deadly consequences associated with a certain type of over-the-counter drug after as little as one dose.
According to the Food and Drug Administration (FDA), the use of sodium phosphate drugs has been linked to kidney damage, heart complications and even death.
Oral Sodium Phosphates (OSPs) are most commonly used to treat constipation and are often given or bowel cleansing prior to a colonoscopy or other procedure. But when administered in too large a dose, OSPs can bring on severe dehydration and altered levels of serum electrolytes within 24 hours.
These effects, in turn, can result in damage to organs, including the heart and kidneys, including nephrophathy. Phosphate, sodium and calcuim are among the serum electrolytes affected.
Sodium phosphate and sodium biphosphate is packaged under the name Fleet, as well as generics and store brands. In some cases sodium phosphate is applied rectally as an enema.
The FDA warns consumers, as well as health-care providers, to use only the recommended dosage after consulting the Drug Facts label on the packaging. Never administer Sodium Phosphate drugs to a child 5 and under without first consulting a health-care professional.
Furthermore, it will require the manufacturer of OsmoPrep and Visicol to include a boxed warning and medication guide as part of an REMS (risk evaluation and mitigation strategy). A post-marketing clinical trial will also be undertaken to measure the risk associated with kidney damage.
The following populations are considered at high risk of acute phosphaet nephropathy, according to the FDA:
- Patients over age 55
- Patients who are dehydrated
- Patients with a history of kidney failure
- Patients with delayed bowel emptying
- Patients with colitis
- Patients who take diuretic pills, ACE inhibitors to lower blood pressure, ARBs for blood pressure and NSAIDs, such as ibuprofen
Warning signs can include lethargy, decreased urination, swollen ankles, drowsiness and malaise. Nephropathy can only be detected by blood test.
It may be weeks or months before signs arise.
Oral Sodium Phosphate medications will continue to be available over the counter. That means consumers must vigilant in order to protect themselves.
Educate yourself on the proper use, as well as the side effects of any drug you use. Be especially cautious when it comes to administering dosage to children.
If you've been injured or become ill after taking Oral Sodium Phosphates, contact Keller & Keller. Our attorneys are experts in Indiana drug cases and can also assist you with your medical malpractice case.