FDA News RECALLS/SAFETY ALERTS June 20, 2005

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FDA News Digest June 20, 2005

 

 

IN THIS WEEK'S ISSUE

 

-- FDA Grants Tentative Approval to Generic Drug for AIDS Relief

-- Antibiotic Treatment Tygacil Approved; First in a New Class

-- Recalls/Safety Alerts

-- Congressional Testimony

-- Public Meetings

-- Question of the Week

 

 

FDA Grants Tentative Approval of Generic Drug for AIDS Relief

 

As part of the President's Emergency Plan for AIDS Relief, FDA has granted tentative approval of generic Lamivudine tablets made by Aurobindo Pharma for the treatment of HIV/AIDS. The agency's tentative approval means that though existing patents or exclusivity agreements prevent U.S. marketing of Aurobindo's product, the drug meets FDA's standards for quality, safety, and effectiveness. Lamivudine -- an "antiretroviral" drug that helps stop HIV from infecting uninfected cells -- is used in combination with other antiretroviral drugs.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01184.html

 

 

Antibiotic Treatment Tygacil Approved; First in a New Class

 

FDA has approved Tygacil for the treatment of adults with complicated intra-abdominal and complicated skin and skin structure infections, including infections due to methicillin-resistant Staphylococcus aureus (MRSA), a type of infection for which there are few treatment options. Tygacil, a glycylcycline antibiotic related to tetracyclines, retains activity against some bacteria that are resistant to tetracyclines.

-- Antibiotic resistance information: http://www.fda.gov/oc/opacom/hottopics/anti_resist.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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RECALLS/SAFETY ALERTS

 

Recalls :

 

Certain models of Guidant Corp.'s implantable defibrillators and cardiac resynchronization therapy defibrillators

Reason for recall: may develop short circuit, resulting in failure

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01185.html

 

Various drug products manufactured by Able Laboratories Inc. and repackaged by Quality Care Products LLC

Reason for recall: products may not have been produced according to quality assurance standards

http://www.fda.gov/oc/po/firmrecalls/qualitycare06_05.html

 

Accusure Insulin Syringes; 1 cc., 28 gauge, 1/2 inch

Reason for recall: mislabeling could cause incorrect dose

http://www.fda.gov/oc/po/firmrecalls/qualitest06_05.html

 

Golden Taste Tuna Deluxe; 3.5-oz. and 7.5-oz. sizes

Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/goldentaste06_05.html

 

Kemps Bakery Classics French Silk Pie Ice Cream; 1/2-gal. size

Reason for recall: undeclared wheat

Initial recall notice: http://www.fda.gov/oc/po/firmrecalls/kemps06_05.html

Four states added to recall: http://www.fda.gov/oc/po/firmrecalls/kemps206_05.html

 

Chocolate cookies contained in Elegant Gourmet's "Camp Survival Kit"

Reason for recall: No ingredient listing is provided for cookies

http://www.fda.gov/oc/po/firmrecalls/elegant06_05.html

 

Lion Pavilion Ltd.'s Dried Cabbage Vegetable; 8.8-oz. size

Reason for recall: undeclared sulfites

http://www.fda.gov/oc/po/firmrecalls/lionpavilion06_05.html

 

Safety Alerts:

 

FDA is asking all sponsors of prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs) to revise their product labeling to include information about the increased risk of cardiovascular events and potentially life-threatening gastrointestinal bleeding. In the case of prescription NSAIDs, FDA has requested that labeling include a boxed warning.

http://www.fda.gov/cder/drug/infopage/COX2/default.htm

 

FDA has approved new labeling for Iressa (gefitinib) that limits the drug's indication to cancer patients who are benefiting or have benefited from treatment with the drug. The manufacturer will limit distribution of the drug under a risk management plan.

http://www.fda.gov/cder/drug/advisory/iressa.htm

 

 

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.]

 

 

CONGRESSIONAL TESTIMONY

 

June 14 -- FDA Center for Food Safety and Applied Nutrition Director Robert E. Brackett, Ph.D., appeared before the Senate Committee on Agriculture, Nutrition and Forestry.

bioengineered foods

http://www.fda.gov/ola/2005/bioengineered0614.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html.

 

 

 

PUBLIC MEETINGS

 

 

 

June 22-23 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

Under discussion: a premarket approval application for a device intended to treat heart failure

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12625dd06222305.html

 

June 23 -- Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

Under discussion: a premarket approval application for a fetal heart monitoring device

Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12524d062305.html

 

June 28 -- Pediatric Ethics Subcommittee of the Pediatric Advisory Committee

Under discussion: a proposed clinical investigation involving children as subjects

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/fda12605d062805.html

 

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

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

 

 

QUESTION OF THE WEEK

 

How can you find out about drug interactions, side effects, or adverse events associated with a certain medicine?

 

The drug labeling, or package insert, that accompanies drug products is the most complete single source of information on the drug. This labeling is available from your local pharmacist and also is reprinted in the Physician's Desk Reference (PDR), which can be found in many libraries. In addition, the package insert is available from the manufacturer and may often be found on the drug manufacturer's Web site. Labeling for drugs approved after 1998 may often be found at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.

 

Another option for finding more information on a drug's side effects is to request this through FDA's Freedom of Information (FOI) Office. You can find out more about this option and how to make an FOI request at http://www.fda.gov/foi/foia2.htm.