FDA News -- FDA News Digest for December 18, 2007

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FDA News Digest

December 18, 2007

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IN THIS WEEK'S ISSUE

» News

-- New Type of 'Beta Blocker' Drug Approved to Treat High Blood Pressure

-- FDA Rule Requires Warning on Nonoxynol 9 OTC Contraceptive Products

-- Genetic Test Recommended for Patients with Asian Ancestry Taking Carbamazepine

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

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NEWS

New Type of 'Beta Blocker' Drug Approved to Treat High Blood Pressure

FDA has approved Bystolic (nebivolol) for the treatment of high blood pressure. Bystolic is a "beta blocker," a well-established class of medications that reduces blood pressure by reducing the force with which the heart pumps. Nearly one in three adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack, kidney failure, and death.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01757.html

FDA Rule Requires Warning on Nonoxynol 9 OTC Contraceptive Products

FDA has issued a final rule today requiring manufacturers of over-the-counter (OTC) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) to include a warning that the chemical N9 does not provide protection against infection from HIV (the virus that causes AIDS) or other sexually transmitted diseases. Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01758.html

Genetic Test Recommended for Patients with Asian Ancestry Taking Carbamazepine

Manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to labeling a recommendation that patients with Asian ancestry, before starting therapy with the drugs, get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction. Carbamazepine is used to treat epilepsy, bipolar disorder, and neuropathic pain. It is sold under the brand names Carbatrol, Equetro and Tegretol.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01755.html

To view an archive of past FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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SAFETY ALERTS/RECALLS

Safety Alert:

› FDA is warning consumers not to use 3.5-oz. packages of Swad brand sindoor, an orange or red powder used in some traditional South Asian Pacific ceremonies that is applied to the face or scalp. The product contains high levels of lead. Although the product was not intended to be sold for food use, its labeling is confusing and implies that it may be used as food. Illinois health officials have confirmed two cases of lead poisoning in consumers who used the product as an ingredient in home-cooked meals.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01756.html

Food Recalls:

› Back to Nature Sesame Ginger Rice Thins Crackers (with "Best When Used By" date of 22FEB2008)

Reason for recall: some product may contain a milk ingredient that is not declared on the label

http://www.fda.gov/oc/po/firmrecalls/backtonature12_07.html

› Wegman's Bouillabaisse Seafood Sauce, 8-oz. size (with "Use By" date up to and including 12/24/07)

Reason for recall: product contains wheat that is not declared on the label

http://www.fda.gov/oc/po/firmrecalls/wegmans122_07.html

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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UPCOMING PUBLIC MEETINGS

For a complete list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.