Update : 1
Subject: Charlie's Produce Spokane Recalls Cut Cantaloupe Products Because of Possible Health Risk (Mar. 22)
Charlie's Produce Spokane Recalls Cut Cantaloupe Products Because of Possible Health Risk (Mar. 22)
Mon, 24 Mar 2008 08:37:00 -0500
The products containing cantaloupe were distributed in Eastern Washington, Idaho, and Montana to retail stores, delis, and foodservice institutions. Products are branded with the Charlie's Produce name and logo, in a hard plastic clamshell, with a Use By date of 3 07 through 3 29 stamped on the bottom of the container.
Update : 2
Subject: FDA Warns Not to Eat Cantaloupe from Honduran Grower
FDA Warns Not to Eat Cantaloupe from Honduran Grower
Sat, 22 Mar 2008 10:28:00 -0500
Due to a risk of Salmonella infection, FDA is warning consumers not to eat cantaloupe from a Honduran company.
Update : 3
Subject: CDER's Small Business Assistance Bulletin
Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via e-mail.
1. FDA has released a progress report on the New Molecular Entities (NME) Post-Marketing Safety Evaluation Pilot Program. http://www.fda.gov/cder/drug/postmarketing_safety/default.htm
2. The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Small Business Assistance, is having a public workshop in Dallas, Texas on April 29, 2008. The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements; good manufacturing practices; OTC and generic drug issues, financial inventives in the development of new drugs and information on FDA's small business assistance programs. http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
3. The Food and Drug Administration (FDA) announced in a Federal Register of March 20, 2008 that the agency is seeking information and comments on issues related to standards for identification, validation, tracking and tracing, and authentication for prescription drug products. Particularly, we are requesting information and comments from drug manufacturers, distributors, pharmacies, other supply chain stakeholders, foreign regulators, standards organizations, and other Federal agencies and interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA also published on the same date a related document listed below entitled ``Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information.'' http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5597.pdf
4. The Food and Drug Administration (FDA) announced in a Federal Register notice of March 20, 2008, that the agency is requesting comments and information regarding technologies used for the identification, validation, tracking and tracing, and authentication of prescription drugs. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5599.pdf
5. The Food and Drug Administration (FDA) announced in a Federal Register notice of March 13, 2008, the availability of a draft guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. Because blood pressure control is well established as beneficial in preventing serious cardiovascular events, FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This draft guidance is intended to recommend standard labeling for antihypertensive drugs except where differences are clearly supported by clinical data. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0150-gdl.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5083.pdf
6. FDA.gov's Home Page Redesign http://www.fda.gov/redesign/default.html
7. 6. As part of FDA gov's Home Page Redesign there is a new website: "FDA Key Initiatives". http://www.fda.gov/oc/initiatives/advance/
8. An updated Center for Biologics Evaluation and Research organizational chart http://www.fda.gov/cber/inside/orgover.pdf and a list of current licensed establishments and products. http://www.fda.gov/cber/establish.htm
9. The U.S. Small Business Administration has released a modernized Lender SOP (Standard Operating Procedure) document. As part of its reform agenda to become easier for lenders to work with, the U.S. Small Business Administration the agency has modernized its SOP for lender and development company loan programs. The revised document, SOP 50 10, has been cut in length from 1,000 pages to 400 and is more logically organized. The SOP is directed to SBA’s Lenders and Certified Development Companies and is streamlined and more user-friendly. http://www.sba.gov/idc/groups/public/documents/sba_homepage/news_release_08_25.pdf
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements, etc. The following information is being sent to you via e-mail.
1. FDA has released a progress report on the New Molecular Entities (NME) Post-Marketing Safety Evaluation Pilot Program. http://www.fda.gov/cder/drug/postmarketing_safety/default.htm
2. The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Small Business Assistance, is having a public workshop in Dallas, Texas on April 29, 2008. The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements; good manufacturing practices; OTC and generic drug issues, financial inventives in the development of new drugs and information on FDA's small business assistance programs. http://www.fda.gov/cder/about/smallbiz/SBAworkshop2008.htm
3. The Food and Drug Administration (FDA) announced in a Federal Register of March 20, 2008 that the agency is seeking information and comments on issues related to standards for identification, validation, tracking and tracing, and authentication for prescription drug products. Particularly, we are requesting information and comments from drug manufacturers, distributors, pharmacies, other supply chain stakeholders, foreign regulators, standards organizations, and other Federal agencies and interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA also published on the same date a related document listed below entitled ``Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information.'' http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5597.pdf
4. The Food and Drug Administration (FDA) announced in a Federal Register notice of March 20, 2008, that the agency is requesting comments and information regarding technologies used for the identification, validation, tracking and tracing, and authentication of prescription drugs. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5599.pdf
5. The Food and Drug Administration (FDA) announced in a Federal Register notice of March 13, 2008, the availability of a draft guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. Because blood pressure control is well established as beneficial in preventing serious cardiovascular events, FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This draft guidance is intended to recommend standard labeling for antihypertensive drugs except where differences are clearly supported by clinical data. http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0150-gdl.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-5083.pdf
6. FDA.gov's Home Page Redesign http://www.fda.gov/redesign/default.html
7. 6. As part of FDA gov's Home Page Redesign there is a new website: "FDA Key Initiatives". http://www.fda.gov/oc/initiatives/advance/
8. An updated Center for Biologics Evaluation and Research organizational chart http://www.fda.gov/cber/inside/orgover.pdf and a list of current licensed establishments and products. http://www.fda.gov/cber/establish.htm
9. The U.S. Small Business Administration has released a modernized Lender SOP (Standard Operating Procedure) document. As part of its reform agenda to become easier for lenders to work with, the U.S. Small Business Administration the agency has modernized its SOP for lender and development company loan programs. The revised document, SOP 50 10, has been cut in length from 1,000 pages to 400 and is more logically organized. The SOP is directed to SBA’s Lenders and Certified Development Companies and is streamlined and more user-friendly. http://www.sba.gov/idc/groups/public/documents/sba_homepage/news_release_08_25.pdf
Ron Wilson Director of Small Business Assistance wilsonr@cder.fda.gov
Update : 4
Subject: Inflammatory Mass Formation Associated with Medtronic Implantable Infusion Pumps - Medical Device Safety
Medtronic Inc. has updated the labeling for certain models of the SynchroMed El, SynchroMed II and IsoMed implantable infusion pumps because of an increase in the reported rate of inflammatory mass formations. The labeling updates include patient management and treatment recommendations.
Update: 5
Subject: CDER New 3/21/2008
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March 21, 2008
- Drug Shortages
- FDA issues an FDA Alert and Information for Healthcare Professionals Sheet for Prezista (darunavir ethalolate).
- New and Generic Drug Approvals
- Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision
- Butalbital, Aspirin and Caffeine Capsules, Mutual Pharma, Labeling Revision
- Hydrocodone Bitartrate and Acetaminophen Oral Solution, Mallinckrodt Inc., Control Supplement
- Hydrocodone Bitartrate and Acetaminophen Tablets, Watson Labs, Manufacturing Revision
- Metoprolol Succinate Extended-Release Tablets, KV Pharma, Approval
- Oxycodone and Acetaminophen Tablets, Watson Labs, Package Change
- Ribavirin Tablets, Zydus Pharma, Packaging Addition
- Ribavirin Tablets, Sandoz Inc., Control Supplement
- Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision
- Zometa (zoledronic acid) Injection, Novartis Pharma, Patient Population Altered
- Paragraph IV Patent Certifications (updated)
Update : 6
Subject: Avoid Fetal Keepsake Images, Heartbeat Monitors
Avoid Fetal Keepsake Images, Heartbeat Monitors
Mon, 24 Mar 2008 13:05:00 -0500
FDA officials are concerned over the marketing of fetal keepsake videos and over-the-counter Doppler ultrasound heartbeat monitors.
Update : 7
Subject: Taking a Close Look at Ultrasound
Taking a Close Look at Ultrasound
Mon, 24 Mar 2008 13:05:00 -0500
Medical ultrasound imagery is used for much more than monitoring fetal health. This article covers different uses of the technology.
Update : 8
Subject: Oncology Drugs Update: FDA Approves Bendamustine Hydochloride (Treanda)
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FDA Approves Bendamustine Hydochloride (Treanda) for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL). More information at:
http://www.fda.gov/cder/Offices/OODP/whatsnew/bendamustine.htm
Update : 9
Subject: CFSAN Constituent Update - March 24, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
March 24, 2008
FDA Warns of Salmonella Risk with Cantaloupes from Agropecuaria Montelibano
The U.S. Food and Drug Administration has issued an import alert regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer, because, based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada. The import alert advises FDA field offices that all cantaloupes shipped to the United States by this company are to be detained.
In addition, the FDA has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove from their stock any cantaloupes from this company. The FDA also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes.
To date, the FDA has received reports of 50 illnesses in 16 states and nine illnesses in Canada linked to the consumption of cantaloupes. No deaths have been reported; however, 14 people have been hospitalized. The states are Arizona, California, Colorado, Georgia, Illinois, Missouri, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Tennessee, Utah, Washington, and Wisconsin.
The FDA is taking this preventive measure while the agency continues to investigate this outbreak in cooperation with the Centers for Disease Control and Prevention and state partners. Such intervention is a key component of FDA’s Food Protection Plan.
Symptoms of foodborne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.
The FDA recommends that consumers take the following steps to reduce the risk of contracting Salmonella or other foodborne illnesses from cantaloupes:
- Purchase cantaloupes that are not bruised or damaged. If buying fresh-cut cantaloupe, be sure it is refrigerated or surrounded by ice.
- After purchase, refrigerate cantaloupes promptly.
- Wash hands with hot, soapy water before and after handling fresh cantaloupes.
- Scrub whole cantaloupes by using a clean produce brush and cool tap water immediately before eating. Don't use soap or detergents.
- Use clean cutting surfaces and utensils when cutting cantaloupes. Wash cutting boards, countertops, dishes, and utensils with hot water and soap between the preparation of raw meat, poultry, or seafood and the preparation of cantaloupe.
- If there happens to be a bruised or damaged area on a cantaloupe, cut away those parts before eating it.
- Leftover cut cantaloupe should be discarded if left at room temperature for more than two hours.
- Use a cooler with ice or use ice gel packs when transporting or storing cantaloupes outdoors.
For more information on produce safety, please visit: Safe Handling of Raw Produce and Fresh-Squeezed Fruit and Vegetable Juices.
For additional information on FDA’s Import Program, please visit: ORA Import Program.
Update : 10
Subject: FDA News Digest
FDA News Digest
March 24, 2008
_____________________________________
IN THIS WEEK'S ISSUE
» News
-- FDA Approves New Medical Adhesive to Treat Burn Patients
» Consumer Health Information FDA Approves New Medical Adhesive to Treat Burn Patients FDA has approved Artiss, a medical adhesive for use in attaching skin grafts onto burn patients. The product contains fibrinogen and thrombin, two proteins essential in the clotting of blood. Artiss differs from other similar sealants because it contains a lower concentration of thrombin, allowing surgeons time to position skin grafts over burns before the graft begins to adhere to the skin.
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.]
_____________________________________________
SAFETY ALERTS/RECALLS
Safety Alert:
Following reports of 50 illnesses in 16 states, FDA has issued an import alert regarding cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer. Based on current information, fruit from this company appears to be associated with a Salmonella outbreak in the United States and Canada. The import alert advises FDA field offices that cantaloupes shipped to the
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01808.html
Food Recalls:
› Acme 4-pack Cinnamon Rolls with Icing (sold in New Jersey, Pennsylvania, Delaware, and Maryland)
Reason for recall: milk component not declared on label
http://www.fda.gov/oc/po/firmrecalls/acme03_08.html
› Certain lots of Bass Pro Shops Uncle Buck's Light 'n Krispy Original (8 oz. pouches and 22-oz. size) and Light 'n Krispy Hot & Spicy (22-oz. size) fish batter mixes; sold in Bass Pro Shops nationwide
Reason for recall: milk component not declared on label
http://www.fda.gov/oc/po/firmrecalls/williams03_08.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.]
____________________________________________________________________
UPCOMING PUBLIC MEETINGS
March 25 -- Pediatric Advisory Committee
Under discussion: adverse events reports for several drugs
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-1296.htm
April 1-2 -- Anti-Infective Drugs Advisory Committee
Under discussion: product development and clinical trial design for community-acquired pneumonia
Location:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-814.htm
April 4 -- Quality System Regulation Educational Forum on Design Controls, a public workshop for regulated industry, especially small businesses
Location: Dallas, Texas
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20077.htm
April 7-8 -- QT and Arrhythmia Issues in Drug Development
Under discussion: development of pharmaceutical agents, as well as challenges and solutions
Location: Bethesda, Md.
For a complete list of meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
http://www.fda.gov/consumer/updates/glucosemeters110107.html
› FDA’s Strategic Plan: Charting Our Course for the Future
http://www.fda.gov/consumer/updates/strategicplan022908.html
To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html
Update : 11
Subject: FDA Data Standards Update - Xform Web Page
Greetings,
The FDA Data Standards Council's website was updated Monday, March 24, 2008, to include a new web page. The new web page http://www.fda.gov/oc/datacouncil/xforms.html contains information about and a link to the xforms.
The link to this new web page has been placed on the FDA Data Standards Council's website home page: http://www.fda.gov/oc/datacouncil/
Lonnie Smith
Project Manager
Food and Drug Administration
Update : 12
Subject: CDER New 3/24/2008
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March 24, 2008
- Guidance for Industry: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [PDF]
- On March 21, 2008, B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). MedWatch Safety Information
- New and Generic Drug Approvals
- Fioricet w/Codeine Capsules, Watson Labs, Labeling Revision
- Gabapentin Tablets, Zydus Pharma, Tentative Approval
- Glycopyrrolate Tablets, Indicus Pharma, Approval
- Ondansetron Injection, Taro Pharma, Approval
- Phentermine Hydrochloride Capsules, KVK-Tech, Approval
- Prozac (fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision
- Prozac (fluoxetine HCl) Solution, Eli Lilly & Co., Labeling Revision
- Prozac (fluoxetine HCl) Delayed Release Capsules, Eli Lilly & Co., Labeling Revision
- Stavudine/Lamivudine/Nevirapine Tablets, Strides Arcolab, Tentative Approval
- Symbyax (olanzapine/fluoxetine HCl) Capsules, Eli Lilly & Co., Labeling Revision
Update : 13
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: March 25, 2008 |
The following new items were added to the CDRH web pages on March 24, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |  |  |
Update : 14
Subject: Medical Device Recalls: Medtronic Implantable Infusion Pumps
You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps Class I Recall has recently been updated, and is now available.
Update: 15
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
Update : 16
Subject: Problems Digesting Dairy Products?
Problems Digesting Dairy Products?
Tue, 25 Mar 2008 11:35:00 -0500
Lactose intolerance can be managed by avoiding or eating less of certain foods and reading labels for hidden sources of lactose.
Update : 17
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 25 Mar 2008 17:04:45 -0500 (CDT)
Subject: Voluntary Nationwide Recall of Honduran Cantaloupes grown by Agropecuaria Montelibano, San Lorenzo Valle, Honduras (March 24)
Voluntary Nationwide Recall of Honduran Cantaloupes grown by Agropecuaria Montelibano, San Lorenzo Valle, Honduras (March 24)
Tue, 25 Mar 2008 15:57:00 -0500
Central American Produce, Inc. of Pompano Beach, FL announces a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras.
Update : 18
Subject: FDA Warns Consumers Not to Use Blue Steel and Hero Products
FDA Warns Consumers Not to Use Blue Steel and Hero Products
Tue, 25 Mar 2008 18:55:00 -0500
These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement.
Update : 19
F
Subject: MedWatch - December 2007 Monthly Safety Labeling Changes Posted on MedWatch Website
  |
The December 2007 posting includes 43 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2007/dec07_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2007/dec07.htm
In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Carbatrol (carbamazepine) Extended-Release Capsules
Equetro (carbamazepine) Extended-Release Capsules
Omniscan (gadodiamide) Injection for Intravenous Use
Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension
Tegretol-XR (carbamazepine extended-release tablets)
Ambien CR (zolpidem tartrate extended-release) Tablets
AndroGel (testosterone gel) 1%
Dostinex (cabergoline) Tablets
Aredia (pamidronate disodium for injection)
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
DepoDur (morphine sulfate extended-release liposome injection)
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil)
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Exjade (deferasirox) Tablets for Oral Suspension
Heparin Sodium Injection, USP
Heparin Sodium Injection, USP (porcine) 5,000 U/mL
Hepsera (adefovir dipivoxil) Tablets
Invega (paliperidone) Extended-Release Tablets
Levaquin (levofloxacin) Tablets and Oral Solution
Levaquin (levofloxacin) Injection, for Intravenous Use
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Monodox (doxycycline monohydrate) Capsules
Sonata (zaleplon) Capsules
Update: 20
Subject: MedWatch - Blue Steel and Hero dietary supplements may cause severe lowering of blood pressure
| |
The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a person’s blood pressure level. They are considered unapproved drugs and have not been proven to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in an FDA-approved prescription drug for ED. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Hero
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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