Request Legal Help Now - Free

Advertisement
LAWSUITS NEWS & LEGAL INFORMATION

Feraheme(R) Label Updated to Reflect Risk for Serious Adverse Events


Lexington, MA: AMAG Pharmaceuticals, Inc has reached agreement with the US Food and Drug Administration (FDA) regarding an update to the product label for Feraheme(R) (ferumoxytol) Injection ) for intravenous (IV) use.

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. The updated product label, also called a package insert, includes, among other things:

Bolded warnings and precautions that describe events that have been reported after Feraheme administration in the post-marketing environment, including life-threatening hypersensitivity reactions and clinically significant hypotension; A new section of the label entitled Adverse Reactions from Post-marketing Spontaneous Reports; and An increase in the observation period following Feraheme administration from 30 to 60 minutes to observe patients for signs and symptoms of hypersensitivity.

The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic/anaphylactoid reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.

In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Patients should be observed for signs and symptoms of hypersensitivity for at least 60 minutes following each Feraheme injection and the drug should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

Legal Help

If you or a loved one has suffered illness or an adverse health event from using this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Nov-30-10


ADD YOUR COMMENT ON THIS ISSUE

Please read our comment guidelines before posting.


Note: Your name will be published with your comment.


Your email will only be used if a response is needed.

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.

Request Legal Help Now! - Free