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FDA Stops Pediatric Testing on Amgen’s Sensipar after Patient Dies

Written by Ankin Law Office

Pediatric studies of Amgen’s Sensipar have been stopped by the U.S. Food and Drug Administration (FDA) after a 14-year-old patient died. In a notice posted on the FDA’s website, the agency stated that it isn’t known whether the drug played a role in the child’s death, but it is discontinuing the testing nonetheless.

Sensipar is currently approved for use in adults to treat a thyroid-related condition, but is currently being studied for potential use in children, as well. According to an article in Fox Business, Amgen is currently conducting three studies regarding the use of Sensipar to treat a condition affecting the parathyroid gland in pediatric patients.

Amgen said in a statement that it 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.”

Last year, Amgen agreed to pay $762 million to settle allegations that it misbranded its anemia drug Aranesp. According to an article in Bloomberg, a plea agreement reached between Amgen and federal prosecutors was accepted by a U.S. District Judge Sterling Johnson in New York on December 19, 2012. Pursuant to the agreement, Amgen will pay $150 million in criminal penalties and $612 million to settle civil claims by various states and whistleblowers who alleged that the company also illegally marketed certain drugs.

FDA Approval Process

Before a pharmaceutical drug can be released into the marketplace, it must be approved by the FDA for a specific purpose. FDA testing requirements and approval processes vary depending on the type of pharmaceutical or medical device that is seeking approval. Some question whether the FDA testing and approval process is adequate, however. For instance, when the Stryker Orthopedics announced that it was recalling its Rejuvenate and ABG II Modular-Neck Hip Implant Systems last year, some critics questioned whether the problems associated with the recalled Stryker hip implant were the result of inadequate medical testing.

Moreover, recent evidence of the addiction nature of opioids like OxyContin have caused many medical experts to express concerns about the role of pharmaceutical companies in the FDA approval and marketing processes. In some cases, evidence regarding the dangers of a pharmaceutical drug won’t become known until after the drug has been approved and made its way into the marketplace, as was the case with drugs like Zoloft and Yasmin.

If you or a loved one has suffered serious side effects or medical complications as a result of a dangerous pharmaceutical drug, contact the skilled Chicago unsafe pharmaceutical drug lawyers at Ankin Law Offices to schedule a free consultation to discuss a possible product liability lawsuit.

Categories: Product Liability