Biologic Drug's Infection Risk Warning Strengthened to "Black Box" Warning
By Miranda Hitti
WebMD Medical News


May 1, 2008 -- The arthritis and psoriasis drug Enbrel now has a "black box" warning about the risk of serious infections that may lead to hospitalization or death.

Enbrel is used to treat rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. It already carried a warning about infection risk. Now, those risks appear in a "black box" warning, the FDA's sternest warning.

The new black box warning notes that infections seen in patients treated with Enbrel have included rare cases of tuberculosis. The warning recommends teaching patients taking Enbrel about infection symptoms, monitoring them for infection during and after treatment with Enbrel, and screening them for tuberculosis before and during Enbrel treatment.

The biologic drugs Remicade and Humira, which are used to treat rheumatoid arthritis, already have boxed warnings about tuberculosis risk.

"Recently we decided that even though TB is uncommon with Enbrel, cases do occur, and we thought it made sense to treat all three products the same by putting a boxed warning on the Enbrel label as well," FDA spokeswoman Karen R. Mahoney tells WebMD in an email. "We hope that screening for TB will further reduce the already low rate of TB with Enbrel."

Amgen and Wyeth, the drug companies that make Enbrel, wrote a letter to doctors in March to tell them about Enbrel's black box warning. That letter now appears on the FDA's web site.

Sweet Prunus avium L. Sour Prunus cerasus L.
 
The fruit my husband?s taste buds anxiously awaits each spring. We eat them other times of the year frozen or canned but our favorite is fresh off the tree? Great for snacks and great cancer fighting, health improving little fruit - Cherries!
 
Cherries are a small, round, red stone fruit. They grow on trees in small clusters. There are both sweet cherries and sour cherries. Sweet cherries are round or slightly heart-shaped.
 
Cherries are eaten fresh, made into pie filling, flavored yogurt, jellies, jams, sauces, stewed fruit, fruit drinks, ice cream and candies. Cherries are a good source of vitamin C, the B vitamins, potassium and many micronutrients. Most sweet cherries are eaten fresh. Almost all sour cherries are processed for canning.
 
Compact, juicy, and colorful, cherries are nicely supplied with nutrients, notably pectin (a soluble fiber that helps control blood cholesterol levels), vitamin C, and beta-carotene, with some potassium. (Sour cherries, which are sometimes called "pie cherries," have considerably more vitamin C than sweet cherries do, though much of it is lost when the cherries are cooked.)
 
Cherries are also high in a number of phytochemicals, including: anthocyanins (pigments responsible for the red and blue colors of fruits and vegetables), which are touted to have anticancer properties based on their antioxidant activities that defend cells against harmful carcinogens; and quercetin, a flavonoid, which is an antioxidant and with anticancer properties as well as anti-inflammatory and antihistaminic properties. It is this anti-inflammatory activity that has made cherries (specifically cherry juice) of interest to people who suffer from gout.
 
Both sweet and sour cherries besides being rich in fiber also contain several vitamins, such as Vitamin A, Thiamin- B1, Riboflavin- B2 and Vitamin C.  Also mixed in are the minerals such as Calcium, Phosphorus, Iron, Sodium, Niacin and Potassium.
 
There's even a possible dental health bonus in that studies have shown that a substance (not yet absolutely  identified) in cherry juice may help prevent tooth decay.
 
Although some people find the cherry pit an annoying feature, the cherry's only other shortcoming is their brief season, which lasts less than 3 months.
 
The two basic categories of cherry: sweet and sour.
 
Sweet Cherries;
 
Bing: There are many commercial varieties of sweet cherries, but the leader is the Bing, a large, round, extra-sweet cherry with purple-red flesh and a deep red skin that verges on black when fully ripe and great fresh.
 
Lambert: The second most popular variety is the Lambert, a smaller, heart-shaped red cherry similar in taste and texture to the Bing.
 
Rainier: The Rainier, a sweet cherry with yellow or pinkish skin, is grown in limited quantities and is milder and sweeter than the Bing.
 
Royal Ann: Another light-skinned variety, the Royal Ann, is often canned or made into maraschino cherries.
 
Sweet cherries are usually shipped immediately, since shelf life is 2 weeks. They are subject to the same post-harvest diseases (brown rot, grey mold, blue mold, Rhizopus, Alternaria, etc..) as other stone fruits.
 
Maraschino cherries are made mostly from sweet cherries, but a small proportion of sour cherries are brined for this purpose. Brined cherries are de-colorized with SO2, then steeped in Marasca, a liqueur distilled from the fermented juice of wild cherries.


Sour cherries:
 
Most commercially grown sour varieties--such as Montmorency, which is the best known--are canned or frozen for use as pie fillings or sauces, although you can occasionally find fresh sour cherries during the summer months at farmers' markets and roadside stands. Sour cherries are smaller than sweet cherries and are a bright scarlet.
 
Both sweet and sour cherries have extremely short shelf lives, and must be handled gently to reduce bruising and oxidation.
 
Sour cherries for processing are dumped into cold water immediately following harvest. They are then transported to processing plants, where they are washed, de-stemmed, pitted, and packed for freezing, all within hours from harvest.
 
A nutrient rich food!
 
Our favorite way of eating cherries are fresh and ready for popping into the mouth. Nothing quite so great as picking and eating when they are in season. But we also love cherry cobblers and pies?
 
Here are two versions of Cherry Cobblers for in season or off!
 
Fresh Cherry Cobbler
 
1 1/4 cups sugar
3 tablespoons cornstarch
4 cups pitted fresh tart cherries
1/4 teaspoon almond extract
1 cup flour
1 tablespoon sugar
1 1/2 teaspoons baking powder
1/2 teaspoon salt
3 tablespoons shortening
1/2 cup milk
 
Preheat oven to 400ºF. Blend 1 1/4 cups sugar, cornstarch, cherries, and almond extract in a medium saucepan. Cook over medium heat, stirring constantly, until mixture thickens and boils. Continue to boil and stir for 1 minute. Pour fruit mixture into an ungreased 2-quart casserole.
 
Place in oven while preparing dough.
 
Measure flour, 1 tablespoon sugar, baking powder, and salt into a mixing bowl. Add shortening and milk. Cut shortening in several times then stir until dough forms a ball. Drop dough in about 6 spoonfuls onto hot fruit. Bake 25 to 30 minutes, or until topping is golden brown. Serve warm with cream, if desired, or cool slightly and serve with vanilla ice cream
 
 
Cherry Cobbler with Biscuit Mix
 
2 tablespoons quick cooking tapioca
2/3 cup sugar
1/8 teaspoon salt
1 can (20 ounces) drained canned tart cherries, reserve juice
1 cup cherry juice (add water to make 1 cup if necessary)
2 teaspoons butter
1 cup biscuit mix
2 tablespoons sugar
1/3 cup evaporated milk
 
Preheat oven to 425ºF.  In a bowl, combine tapioca, 2/3 cup sugar, 1/8 teaspoon salt, cherries and the 1 cup cherry juice (if there isn't enough cherry juice to make 1 cup, add a little water). Mix and put into a lightly buttered 1 1/2-quart baking dish. Dot top of cherry mixture with 2 teaspoons butter, cut in small pieces. Bake at 425? for 12 minutes.
 
Then add dumplings: In a mixing bowl, combine biscuit mix, 2 tablespoons sugar, and evaporated milk. Remove cherry mixture from the oven and drop dough by tablespoonfuls on top to make 4 dumplings.
 
Return to oven and bake for about 12 minutes longer, or until dumplings are lightly browned.
 
Cherry Cobbler serves 4. Best served warm.
 
Enjoy
Lena