US halts Amgen study after teen patient death (Update)

U.S. government health regulators have halted Amgen's studies of its drug Sensipar after the death of a 14-year-old patient in a company trial.

The Food and Drug Administration said Tuesday it is still gathering information about the death, but has shut down all studies of the drug in children.

Sensipar is approved in adults to treat over-activity of the parathyroid gland, which can lead to brittle bones, kidney stones and abdominal pain. It has been used since 2004 to treat symptoms of chronic kidney disease and parathyroid cancer.

Amgen Inc. had been studying the drug to see whether it works in children.

The Thousand Oaks, California-based company said in a statement that it "is working as rapidly as possible to understand the circumstances of what happened."

The FDA said on its website that it is unclear whether Amgen's drug had a role in the patient's death, but it is reminding doctors to prescribe it carefully.

The drug is known to lower calcium levels, sometimes to a dangerous extent.

The agency says doctors should monitor patients' calcium levels monthly to make sure they don't fall to dangerous levels. Signs of a calcium deficiency include muscle cramping, convulsions and burning or prickling sensations.

The most common side effects of the drug in adults include nausea, vomiting and diarrhea.

Amgen reported annual sales of $800 million for Sensipar in 2011, its most recent full-year financial report.

Company shares fell 7 cents to $89.48 in afternoon trading Tuesday.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Patient privacy focus of Amgen suit

Jan 09, 2008

Two former employees with the California biotech company Amgen Inc. allege the company persuaded sales people to access patient records to boost sales.

Amgen buys Micromet for anti-leukemia drug

Jan 26, 2012

Biotech giant Amgen said Thursday it was buying the German-American cancer research firm Micromet, giving it access to Micromet's promising leukemia therapy.

Marqibo approved for rare leukemia

Aug 10, 2012

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with a rare form of blood and bone marrow cancer, Philadelphia chromosome negative ...

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

User comments