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FDA Warning to Pediatricians

The Lancione Law Firm

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 recalculated.

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 immediately.

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

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