Another Heparin related Recall, Medtronic, Inc. Recalls Heparin-Coated Products Used During Cardiopulmonary Bypass.

Recallr is reporting another heparin related recall. The company is Medtronic INC and the products are those which featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
Recallr: Medtronic, Inc. Recalls Heparin-Coated Products Used During Cardiopulmonary Bypass.
Tags: FDA Recall, heparin recalls, Medtronic Recall, Heparin-Coated Products Recall, Carmeda BioActive surface Recall, blood oxygenators, reservoirs, pumps, cannulae, tubing packs

Food Allergens, Don't Risk Your Life On Them

Summer is here soon and we will be running around soaking in the sun going on trips and having parties. These are times that we are in a hurry and may fail to look at food labels and may forget to ask hosts about party foods they are serving. So what happens next is food allergies making all the fun times not so fun times.

So learning about food allergens and allergies make life easier for everyone during the summer and beyond.

While more than 160 foods can cause allergic reactions in people with food allergies, the law identifies the eight most common allergenic foods. These foods account for 90 percent of food allergic reactions, and are the food sources from which many other ingredients are derived.

The eight foods identified by the law are:
Milk Eggs Fish (e.g., bass, flounder, cod) Crustacean shellfish (e.g. crab, lobster, shrimp) Tree nuts (e.g., almonds, walnuts, pecans) Peanuts Wheat Soybeans

These eight foods, and any ingredient that contains protein derived from one or more of them, are designated as "major food allergens" by the law.

How Major Food Allergens Are Listed

The law requires that food labels identify the food source of all major food allergens. Unless the food source of a major food allergen is part of the ingredient's common or usual name (or is already identified in the ingredient list), it must be included in one of two ways.

The name of the food source of a major food allergen must appear:

1. In parentheses following the name of the ingredient.
   Examples: "lecithin (soy)," "flour (wheat)," and "whey (milk)"

– OR –

2. Immediately after or next to the list of ingredients in a "contains" statement.
   Example: "Contains Wheat, Milk, and Soy."

Know the Symptoms

Symptoms of food allergies typically appear from within a few minutes to two hours after a person has eaten the food to which he or she is allergic.

Allergic reactions can include:
Hives Flushed skin or rash Tingling or itchy sensation in the mouth Face, tongue, or lip swelling Vomiting and/or diarrhea Abdominal cramps	Coughing or wheezing Dizziness and/or lightheadedness Swelling of the throat and vocal cords Difficulty breathing Loss of consciousness

About Other Allergens
Persons may still be allergic to — and have serious reactions to — foods other than the eight foods identified by the law. So, always be sure to read the food label's ingredient list carefully to avoid the food allergens in question.

What to Do If Symptoms Occur

The appearance of symptoms (see Know the Symptoms at right) after eating food may be a sign of a food allergy. The food(s) that caused these symptoms should be avoided, and the affected person, should contact a doctor or health care provider for appropriate testing and evaluation.

• Persons found to have a food allergy should learn to read labels and avoid the offending foods. They should also learn, in case of accidental ingestion, to recognize the early symptoms of an allergic reaction, and be properly educated on — and armed with — appropriate treatment measures.

• Persons with a known food allergy who begin experiencing symptoms while, or after, eating a food should initiate treatment immediately, and go to a nearby emergency room if symptoms progress.

Tags: food allergies, food allergens

Safety Tips For Riding Escalators! For All Seasons!

We all love escalators, they take you up and down the floors and give our tired feet a rest after tiresome shopping or some times work. Escalators have become so much part of our lives, that we do not notice them any more. We just ride them up and down.
Escalators are mechanical devices and can give you and I a lot of trouble if we do not take care. It is just simple steps that is necessary to be safe while riding escalators. Following is an CPSC bulletin; Know the Steps to Safety When Using Escalators
Some shoes more likely than others to pose risk
Each year the ride between floors is made easier when an estimated 90 billion riders use an escalator. Although most of those rides are without incident, the CPSC estimates there were approximately 11,000 escalator related injuries in 2007. The majority of these injuries are from falls but 10 percent occur when hands, feet or shoes are trapped in escalators.
The most common entrapment is to the foot. Soft-sided shoes are the most likely to get stuck and pose the possibility of injury to the rider. CPSC is aware of 77 entrapment incidents since January 2006, with about half resulting in injury. All but two of the incidents involved popular soft-sided flexible clogs and slides.
Here are some steps you can take to prevent escalator injuries:

Make sure shoes are tied before getting on an escalator.

Stand in the center of the step and be sure to step off of the escalator at the end of your ride.

Always hold children's hands on escalators and do not permit children to sit or play on the steps.

Do not bring children onto escalators in strollers, walkers, or carts.

Always face forward and hold the handrail.

Avoid the sides of steps where entrapment can occur.

Learn where the emergency shutoff buttons are in case you need to stop the escalator.

Tags: CPSC News, escalator safety

Some Ayurvedic Medicinal Products Contain High Levels of Heavy Metals

Hindi version of Health Canada Advisory (PDF version - 47.6 KB)
Health Canada is advising to watch out for heavy metals in unapproved Ayurvedic medicinal products. Some of these products contain excessive amounts of mercury,arsenic and lead which are of course harmful to anyone but specifically to children. These metals usually accumulate in the body and create adverse conditions to users.

The toxic effects of lead may include abdominal pain, anaemia, changes in blood pressure, reproductive effects, weakness, concentration problems, weight loss, insomnia, dizziness, kidney and brain damage. The toxic effects of mercury may include irritability, tremors, memory loss, insomnia, and concentration problems. Mercury can permanently damage the brain and kidneys. The toxic effects of arsenic may include skin and lung cancers, as well as heart and kidney disease and liver damage.

The Health Canada has a specific case where in March 2008, a domestic case of heavy metal poisoning was published in the British Columbia Medical Journal, involving an adult male with symptoms of vomiting and diarrhea. The patient had been taking one tablet daily of the unauthorized Ayurvedic product Puspadhanva Rasa over a number of years to "increase vigour". Puspadhanva Rasa is manufactured by the Shri Dhanwantri Ayurvedic Pharmacy in India. The patient purchased this product in India and imported it into Canada for personal use. The product was found to contain extremely high levels of lead, mercury and arsenic.

Consumers should exercise caution when purchasing health products from outside Canada or over the Internet, as these products may not have undergone the same degree of assessment as those authorized for sale in Canada. Authorized health products will either bear an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN), or a Homeopathic Drug Number (DIN-HM). These numbers indicate that the product has been assessed by Health Canada for safety, efficacy and quality.

Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709

Consumers who find this product on the Canadian market are asked to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675.

Consumers who have used this product and who are concerned about their health should contact a health professional for advice.

To report a suspected adverse reaction to one of these products please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9

E-mail: CanadaVigilance@hc-sc.gc.ca

Tags: Health Canada, Medical Advisory, Ayurvedic Medicine, Heavy Metals in Medicine, unapproved Ayurvedic medicinal products, Puspadhanva Rasa, Shri Dhanwantri Ayurvedic Pharmacy

New Formulation of Coagulation Therapy, NovoSeven RT Approved by FDA

FOR IMMEDIATE RELEASE May 9, 2008

Media Inquiries: Peper Long, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New Formulation of Coagulation Therapy
NovoSeven RT Can Be Stored at Room Temperature

The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years.

"Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians," said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. "As with all FDA-approved products, the agency will monitor NovoSeven RT throughout its life cycle."

NovoSeven RT—the new formulation of NovoSeven Coagulation Factor VIIa (Recombinant)—contains sucrose and L-Methionine, which allow for storage at room temperature. This is helpful for health-care facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees Fahrenheit.

NovoSeven RT shares the same uses as the earlier NovoSeven product. These uses include the treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B, who have antibodies that neutralize the action of clotting Factors VIII or IX; the treatment of bleeding and the prevention of surgical bleeding in patients with congenital Factor VII deficiency; and the prevention of surgical bleeding in patients with acquired hemophilia.

Coagulation factors are proteins found in plasma, which help blood clot. When one or more of these proteins are missing or inactive, bleeding can occur.

The most commonly observed adverse reactions with NovoSeven RT are fever, bleeding, injection site reaction, joint discomfort, headache, elevations or falls in blood pressure, nausea, vomiting, pain, swelling, and rash. Some elderly patients experienced an increased risk of arterial clotting when they were treated with NovoSeven RT outside of its approved indications.

NovoSeven RT and NovoSeven Coagulation Factor VIIa (Recombinant) are manufactured by Novo Nordisk A/S, located in Denmark.

Tags: FDA Approval, Coagulation Therapy, Factor VIIa, plasma protein, NovoSeven RT

Update And Request On Heparin Sodium Injection (Baxter)

[UPDATE 05/09/2008] FDA requested that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use. In addition, FDA informed health professionals about other types of medical devices that contain, or are coated with, heparin.

[UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

Tags: FDA Recall, Drug recall, Heparin Recall, Baxter Recall

Generic (Requip,)Ropinirole, For Treatment of Restless Legs Syndrome Approved By FDA

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.

"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.

The following companies have received approval to market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.

The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.

The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving. Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.

For information:

Drugs@FDA
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Consumer Education: Generic Drugs
www.fda.gov/cder/consumerinfo/generic_text.htm

GridTags: FDA Approval, Drug Approval, Requip, ropinirole hydrochloride, Restless Legs Syndrome, RLS, Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., Mylan Pharmaceuticals Inc