FDA Suspends Sensipar Trials Following Death Of Teenager

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FDA Suspends Sensipar Trials Following Death Of Teenager

Main Category: Clinical Trials / Drug Trials
Also Included In: Pediatrics / Children's Health | Regulatory Affairs / Drug Approvals
Article Date: 28 Feb 2013

The U.S. Food and Drug Administration recently announced it has stopped all pediatric clinical trials of the drug Sensipar, following the death of a 14 year old patient who took part in one of the studies.

Sensipar is a drug, developed by Amgen Inc, that reduces the levels of calcium in the blood by decreasing the release of parathyroid hormone (PTH) from the parathyroid gland. Having high levels of calcium can be the cause of a number of health problems, it has been associated with an increased risk of heart attack.

If calcium levels become too low though, there can also be health risks.

The agency states that they are not yet certain if the drug had anything to do with the death of the teenager and that they will continue to evaluate all the information available.

Amgen Inc is the largest biotech company in the world, last week it sent a letter to healthcare providers informing them of the teenagers death and the trials' suspension.

The company said: "Amgen is working as rapidly as possible to understand the circumstances of what happened. This analysis is ongoing and will be concluded as quickly as possible,"

Sensipar, which had sales close to $950 million in 2012, is not approved for children. It is strictly approved for adults, to treat:

secondary hyperparathyroidism in patients with chronic kidney disease
hypercalcemia in patients with parathyroid cancer
hypercalcemia in patients who aren't able to undergo parathyroidectomy

The FDA reminds doctors that patients on Sensipar should consistently be monitored for the development of low serum calcium levels.

Some indicators of low serum calcium levels are:

Tetany (intermittent muscular spasms)
Parethesias (pins and needles)
Mylagias (pain in muscles)
Muscle cramping
Convulsions

If calcium levels drop too low, healthcare professionals should ensure that measures are made to try and bring the levels back up, by either increasing the dose of vitamin D sterols, providing calcium supplements, or suspending treatment with the drug.

Within a week after initiation of the drug or following any dosage adjustments, doctors should make sure they measure calcium levels and monthly follow-ups to check the levels.

The most commonly reported side effects of the drug include nausea, diarrhea, and vomiting.

The FDA said: "We urge both health care professionals and patients to report adverse events involving Sensipar to the FDA MedWatch program."

To report a serious problem, or adverse event involving Sensipar to the FDA, call:

1-800-332-1088
1-800-FDA-0178 Fax

Or use the FDA's MedWatch Online reporting process.

Written by Joseph Nordqvist
Copyright: MediLexicon International Ltd

Original article posted on Medical News Today.
Articles not to be reproduced without permission of Medical News Today

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