FDA Suspends Pediatric Trial Of Common Drug

Categories: Uncategorized

In a concerning development, the U.S. Food and Drug Administration ended a clinical trial of a common calcium receptor drug known as Sensipar or cinacalcet hydrochloride. While the FDA approved this drug years ago for several uses in adult patients, the company’s manufacturer was undertaking further trials to determine whether the drug is also safe and effective for children.

However, one of the 14-year-old trial participants died while taking Sensipar. The FDA quickly suspended the clinical trial and the company sent a letter to healthcare professionals about the death.

Ohio parents need to be aware of this situation for several reasons – children with kidney disease or hypercalcemia may be at risk if a physician or pharmacist mistakenly dispenses Sensipar. Although the company behind this drug notified many health professionals about the death in its study, parents should not assume that all doctors will receive or pay attention to this notification.

Because the FDA cannot interfere with physicians’ ability to exercise their medical judgment, doctors are often allowed to prescribe medications “off label” or “unapproved uses.” This means that a doctor could potentially ignore the existing label notes saying that Sensipar is not approved for children – and this could have catastrophic results.

If a pharmaceutical or prescription error causes serious injuries or even death, children or their families may have a claim under medical malpractice laws.

Source: MedPage Today, “Death Halts Sensipar Trials in Kids” Todd Neale, Feb. 26, 2013

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