March 28, 2001 (Washington) -- Government regulators on Wednesday issued a warning to healthcare professionals regarding the use of the popular prescription heartburn drug Pepcid in patients with moderate kidney problems. This warning, however, does not apply to over-the-counter versions of the medication.
In a letter from the FDA, regulators said they have now received reports of adverse events related to the central nervous system in patients with moderate kidney impairment.
Because elderly patients are more likely to have decreased kidney function, the regulators recommend that healthcare professionals take special care when prescribing doses for elderly patients.
Currently, the label for prescription-strength Pepcid urges physicians to adjust doses for patients with severe kidney problems, or renal insufficiency, by reducing the dose or increasing the time interval between doses. The new warning includes patients with moderate kidney failure.
"Today's announcement was based upon reports of [abnormal drowsiness] in patients with poor renal function," Jason Broadsky, an FDA spokesman, tells WebMD.
The present warning affects only the prescription version, Broadsky says. But the FDA also is reviewing whether a warning is needed for the over-the-counter version, he tells WebMD.
The prescription version is available in several formulations, including 20-mg and 40-mg tablets, as well as premixed and nonpremixed versions for injection. The over-the-counter version is a 10-mg tablet that comes in packages of 15, 25, and 50 chewable tablets.
To date, the FDA has received no reports of deliberate Pepcid overdoses. Oral doses of up to 640 mg a day have been given to adult patients with no serious adverse events.
The warning comes because FDA officials have verified a direct connection between levels of the drug and an increase in creatinine, a waste product found in the urine that is considered a sign of kidney failure.
Doctors already know that it takes the body a long time to process the medicine and remove it from the body -- even in patients with normal kidney function. But in patients with decreased kidney function, the drug remains in the body longer. In patients with severe kidney disease, the drug has been found to remain in the patient's system for more than 20 hours by some reports. This higher level of medication could lead to side effects, such as abnormal drowsiness or lethargy.
Also, if an over-the-counter medication, when taken as directed, does not alleviate all symptoms, it is time to alert your family physician or another healthcare professional instead of continuing to self-medicate.
Merck and Co. of Whitehouse Station, N.J., the maker of Pepcid, did not return requests for comment at the time this story was written.