FDA Warning to Pediatricians

by | Mar 4, 2015 | Firm News, General Interest, Medical Malpractice, Medication Errors |

The federal Food and Drug Administration has recommended that pediatricians
lower dosages of the antiviral drug Valcyte in both the oral solution
and tablet forms.

The drug is used in to prevent cytomegalovirus (CMV) in children ages four
months to 16 years who have undergone a heart, kidney or kidney-pancreas
transplant. CMV is a herpes-type virus that can generate disease in different
parts of patients’ bodies. Valcyte is designed to help weakened
immune systems fight off CMV infections.

Overdose Side Effects

Side effects from a Valcyte overdose may include:

  • Abdominal pain
  • Vomiting
  • Diarrhea
  • Tremors
  • Seizure

The FDA recommended a lower dosage of the drug to prevent overdosing in
kids with low body weight, with low body surface area and with a below-normal
level of serum creatinine.

Creatinine levels in the blood are indicative of how effectively kidneys
are functioning. High creatinine levels can be a signal of weak kidney
function; low creatinine levels can be found in patients with low muscle mass.

Patients Routinely Ignored

The FDA states that patients with low weight, body surface area and levels
of creatinine levels were not routinely observed when the maker of Valcyte
conducted its clinical trials. It’s therefore possible that children
with those conditions have been overdosed before the Valcyte dosage was

The FDA says no child should now receive more than 900 mg of the medication.

What Parents Should Do

Parents who observe, or have observed, the symptoms of Valcyte overdoses
in their children are advised to contact their health care professionals

For those parents whose children have been harmed by a Valcyte overdose,
contact a Cleveland, Cleveland Medical Malpractice attorney who can evaluate
the facts of the case and help you understand your legal options.


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