Recent FDA Warnings Reminders of Dangers of Pharmaceuticals

A couple of recent announcements by the U.S. Food and Drug Administration (FDA) spotlight the potential health dangers of pharmaceutical products.

Intestinomicina Warning: Patients May be at Risk for Serious or Fatal Injury

The FDA has issued a warning for consumers to not use the drug product Intestinomicina. Manufactured in El Salvador and sold in international grocery stores throughout the United States, Intestinomicina is marketed as a treatment for infectious diarrhea and acute gastrointestinal infections.

The reason for the FDA's warning is that Intestinomicina has found to contain chloramphenicol, a prescription drug ingredient. Sales of oral forms of chloramphenicol were ended in this country in July 2012 due to risks of serious, even life-threatening, injuries. The most severe potential side-effect is bone marrow toxicity, a condition that occurs when the body does not produce enough red or white blood cells, and/or platelets. Bone marrow toxicity can be fatal. Those with anemia or low white or red blood cell counts are most in danger of death or serious injury.

Revatio Should Not be Prescribed to Children

In another recent FDA warning, this time to doctors and medical care organizations, the potential dangers of prescribing Revatio to treat pulmonary arterial hypertension in young patients were outlined. Revatio typically is used to treat adult pulmonary arterial hypertension - abnormally high blood pressure in the arteries of the lungs - by relaxing the lungs' blood vessels to lower the patient's blood pressure. The FDA says that Revatio should not be prescribed to children ages 1 through 17.

In a recent long-term clinical pediatric trial, it was shown that children taking a high dose of Revatio face a higher risk of death than children taking a low dose. It also showed that low doses do not improve exercise ability in children, which is another approved use of Revatio for adult patients.

Those who have suffered serious injuries from any incorrectly prescribed medicines, or from medicinal products that have been found to pose dangerous side effects, may want to consult an attorney and explore their legal rights to pursue compensation.


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