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

Seaweed menace may yield new medicines

10 hours ago

An invasive seaweed clogging up British coasts could be a blessing in disguise. University of Greenwich scientists have won a cash award to turn it into valuable compounds which can lead to new, life-saving drugs.

Supercomputers link proteins to drug side effects

Oct 20, 2014

New medications created by pharmaceutical companies have helped millions of Americans alleviate pain and suffering from their medical conditions. However, the drug creation process often misses many side ...

User comments