According to the FDA, some patients have died after the administration of Dexferrum, an iron dextran injection product. American Regent, manufacturer of Dexferrum sent a letter healthcare professionals stating that the boxed warning for Dexferrum had been changed to do the following:

1. Emphasize the warning about the risk of anaphylactic-type reactions from Dexferrum
2. Provide precautionary measures to mitigate the risk of anaphylactic-type reactions from Dexferrum
3. Add statements to clarify the differences in the chemical characteristics and clinical effects of iron dextran preparations to minimize potential confusion between products
   

A Dexferrum lawsuit would allege that American Regent failed to adequately warn the patient of the risks of anaphlylactic shock and failed to provide adequate instructions for administration. For a free consultation about a Dexferrum lawsuit, please call 1-888-377-8900 (toll free), email Attorney Fred Pritzker or submit our online free consultation form.
Clearly, American Regent should have provided enough information in the instructions for Dexferrum for medical professionals to administer the product safely.

The new boxed warning now provides the following information:

• Health professionals should administer a test dose of Dexferrum® prior to the first therapeutic dose; if no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic dose.
• Health professionals should observe the patient for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.
• Fatal reactions have occurred following the test dose of Dexferrum and have also occurred when the test dose of Dexferrum was tolerated.
• Health professionals should note that patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions.
  

Below is the language on the new boxed warnings for Dexferrum:

Risk for Anaphylactic-type Reactions: Warnings regarding the risk for anaphylactic-type reactions have existed in the Warnings section prior to this change. The information that has been added provides guidance on patient observation following the administration of both the test dose and therapeutic administration and elevates the precaution about potential increased risks with concomitant use of angiotensin-converting enzyme inhibitor drugs. This new subsection also addresses the chemical differences and clinical effects of the available iron dextran products.

IMPORTANT SAFETY INFORMATION
Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.

Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Dexferrum® (iron dextran injection, USP) administration.

Administer a test Dexferrum® dose prior to the first therapeutic dose.

During all Dexferrum® administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran injection and in situations where the test dose was tolerated.

Use Dexferrum® only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.

Labels: Lawsuit, Lawyers, wrongful death

ADHD Medications that may be associated with sudden death in healthy children, according to the FDA: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

Research data published in the American Journal of Psychiatry suggests there may be an association between the use of stimulant medications prescribed to children with ADHD and sudden death in healthy children.

If your child has died or become seriously ill while using any of the ADHD medications above, the most common of which is Ritalin: 1) call our lawyers at 1-888-377-8900 (toll free) or 2) submit our free consultation form for review by our lawyers.

In the study, funded by the FDA and the National Institute of Mental Health (NIMH), the investigators compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, most likely due to sudden cardiac disturbance, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. According to the study report, out of 564 healthy children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Out of 564 healthy children who died in a motor vehicle accident, two were reported to be taking a stimulant medication at the time of death.

Labels: Lawsuit, Lawyers, wrongful death