Mission Pharmacal Launches Ferralet® 90 for Treatment of the Leading Cause of Anemia in the U.S. Designed to improve on existing oral iron therapies
SAN ANTONIO, TX (May 20, 2008) – Mission Pharmacal announced the launch of Ferralet® 90, a new prescription oral iron supplement for treatment of iron deficiency anemia (IDA) that is responsive to oral iron therapy. IDA is a depletion of stored iron that prevents maturation of red blood cells. Ferralet 90 contains 90 mg of carbonyl iron as well as essential vitamins and minerals to help patients replenish iron stores in an effective, safe and tolerable manner. Iron deficiency is the most common nutritional deficiency and the leading cause of anemia in the United States.1
"If left untreated, IDA has the potential to interfere with the body's vital functions, such as the nervous system, cardiovascular and immune system function. Women of child bearing age are at highest risk of developing iron deficiency anemia, and screening for IDA should be part of every woman's annual medical check up exam," said Miriam Nelson, Ph.D., a leading health and nutrition expert and author of the best-selling Strong Women book series. "The good news is that new IDA supplements, such as Ferralet 90, that are effective and tolerable can help restore iron levels back into normal range."
One in five women is iron deficient and at risk for developing anemia.2 Menstruation is a leading cause of iron deficiency anemia in women by the Centers for Disease Control and Prevention.3
Women with IDA may better tolerate Ferralet 90 over other traditional iron supplements. Ferralet 90 contains carbonyl iron, which works with the body to regulate absorption at a rate determined by gastric acid production. This prolonged solubilization and absorption is the key to carbonyl iron's safety and tolerability.4 Ferralet 90 is free of lactose and gluten, features a vanilla scent and contains docusate sodium, a gentle and effective stool softener, to help prevent side effects that may occur in women who are sensitive to iron therapy.
Ferralet 90 also contains vitamin C to further aid in iron absorption, folic acid to bolster red blood cell development and vitamin B12 to support red blood cell generation.
"Mission Pharmacal recognizes the unique health and nutritional needs of women and is proud to offer healthcare providers an improved option to help meet the specific needs of iron deficiency anemia patients in the United States," said Neil Walsdorf, Jr., president of Mission Pharmacal. "Ferralet 90 builds on the benefits of existing iron supplements, but offers additional vitamins and minerals to help improve the overall health of women and aid in compliance."
About Ferralet® 90
Ferralet® 90 is marketed by Mission Pharmacal Company based in San Antonio, Texas. Ferralet 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence and dietary needs. Ferralet 90 is available by prescription.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Ferralet 90 should be kept out of the reach of children. In case of accidental overdose of Ferralet 90, call a doctor or poison control center immediately. Please see full Prescribing Information, including boxed WARNING, for Ferralet 90 at www.ferralet90.com.
About Mission Pharmacal
Mission Pharmacal is a privately-held pharmaceutical company based in San Antonio, Texas. For more than 60 years, the company has been dedicated to identifying unmet health needs in the marketplace and developing innovative prescription and over-the-counter products to meet them. Currently, Mission Pharmacal provides physicians and consumers with pharmaceutical and nutritional products. For more information, visit www.missionpharmacal.com.
Media Contact:
Ami Shah
cohn&wolfe
(212) 537-8048
ami.shah@cohnwolfe.com
Important Safety Information
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
Warning
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Precautions
Administration of Drug- General: Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. The type of anemia and underlying cause or causes should be determined before starting therapy with Ferralet® 90 tablets. Ensure Hgb, Hct, reticulocyte count are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated. This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
- Folic Acid: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using these products since folic acid may mask the symptoms of pernicious anemia.
- Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
- Geriatric Use: Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.
This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.
Please see full Prescribing Information
- Iron deficiency--United States, 1999-2000 [Internet]. Centers for Disease Control and Prevention (CDC); 2002 Oct 11 [accessed 2008 Apr 9]. Available from: http://www.cdc.gov/MMWR/preview/mmwrhtml/mm5140a1.htm.
- Iron Deficiency Anemia [Internet]. MayoClinic.com; [cited 2008 May 20]. Available from: http://www.mayoclinic.org/anemia/irondeficiencyanemia.html.
- Recommendations to prevent and control iron deficiency in the United States [Internet]. Centers for Disease Control and Prevention; 1998 Apr 3 [accessed 2008 Apr 9]. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/00051880.htm.
- Brittenham GM, Klein HG, Kushner JP, Ajioka RS. Preserving the national blood supply. Hematology Am Soc Hematol Educ Program. 2001:422-32.
