Health Alert: Rid Your Diet of These 2 Health Bombs Now
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FDA News Digest for February 11, 2008
FDA News Digest
February 11, 2008
_____________________________________
IN THIS WEEK'S ISSUE
» News
-- Generic Versions of Osteoporosis Treatment Fosamax Approved
» Consumer Health Information Generic Versions of Osteoporosis Treatment Fosamax Approved FDA has approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of bones. Teva Pharmaceuticals USA was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., was approved to manufacture a 70-milligram, once-weekly, dose of the drug. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01793.html First 'Decellularized' Heart Valve May Lower Immune Response Risk FDA has cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed. The CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) undergoes a process that "decellularizes," or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of immune response and subsequent tissue rejection. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01794.html FDA Acts to Stop Marketing of Unapproved Injectable Colchicine FDA plans to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. 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 Alerts: › FDA has issued a notice that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses. The agency has said the reactions may be related to overdosing and emphasizes that there is no evidence that these reactions are related to any defect in the products. The adverse effects were found in FDA-approved and in nonapproved usages of the products. The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and they mimic symptoms of botulism, which may include difficulty swallowing, weakness, and breathing problems. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01796.html › FDA has announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive large and fast ("bolus") doses of the drug. Serious reactions to the drug have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock. Four people have died after receiving heparin, although the relationship to the drug is unclear. Medical Device Recall: › Icy Hot Heat Therapy products Reason for recall: reports by consumers of burns 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 For a complete list of FDA meetings, seminars, and other public events, go to __________________________________________ NEWS
Here's what's in the spotlight this week:
› FDA 101: Product Recalls
From First Alert to Effectiveness Checks
http://www.fda.gov/consumer/updates/recalls123107.html
› Vital Facts About HIV Home Test Kits
http://www.fda.gov/consumer/updates/hivtestkit012908.html
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FDA MedWatch - Heparin Sodium Injection - Serious Adverse Events Reported In Patients Receiving Bolus Doses Of Medication
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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.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Q & A Document, and News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2
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Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions
Mon, 11 Feb 2008 11:10:00 -0600
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.
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FDA Press Releases Update
Correction: This press release was originally issued on February 1, 2008, and was inadvertently resent today. We apologize for any confusion.
FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Fri, 1 Feb 2008 11:49:00 -0600
The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.
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Good Clinical Practice February 2008 Update
From: Office for Human Research Protections (OHRP) [OHRP-L@LIST.NIH.GOV]
on behalf of Glen Drew [glen.drew@HHS.GOV]
Sent: Monday, February 11, 2008 1:50 PM
To: OHRP-L@LIST.NIH.GOV
Subject: OHRP Spanish Pamphlet Now Available
OHRP is pleased to announce that its pamphlet "Becoming a Research
Volunteer: It's Your Decision" is now available in Spanish, "Ser
Voluntario en Estudios Clínicos: Es Su Decisión."
You may order up to 50 (fifty) free copies by calling OHRP's toll-free
number, (866) 447-4777. You may also download at no charge an electronic
copy at http://www.hhs.gov/ohrp/espanol/OHRP3PanelSpanish.pdf
for your
own reprinting and distribution.
OHRP would like to hear about your experiences with the Spanish pamphlet.
Please tell us about them at ohrp@hhs.gov.
You are a subscriber to the Good Clinical Practice/ Human Subject Protection e-mail update service provided by the U.S. Food & Drug Administration (FDA). The attached information was recently distributed by DHHS's Office for Human Subject Protections; this may be of interest to you.
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FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Fri, 1 Feb 2008 11:49:00 -0600
The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.
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CDER New 2/7 & 8/2008
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February 8, 2008
February 7, 2008
- Adverse Event Reporting System (AERS) Latest Quarterly Data Files
- Drug to be Discontinued: Humatin (Paromomycin Sulfate Capsules, USP)
- On February 6, FDA approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis.
- New and Generic Drug Approvals
- Alendronate Sodium Tablets, Teva Pharma, Approval
- Alendronate Sodium Tablets, Barr Labs, Approval
- Cefuroxime Axetil Oral Suspension, Ranbaxy, Approval
- Daytrana (methylphenidate) Transdermal System, Shire Development, Labeling Revision
- Esomeprazole Magnesium Delayed-Release Capsules, Ranbaxy Labs, Tentative Approval
- Imodium Advanced (loperamide HCl and simethicone) Tablets, McNeil Consumer Healthcare, Labeling Revision
- MoviPrep Oral solution, Salix Pharma, Labeling Revision
- VFEND (voriconazole) Tablets, Pfizer Inc., Labeling Revision
- VFEND I.V. (voriconazole) Injection, Pfizer Inc., Labeling Revision
- VFEND (voriconazole) Oral Suspension, Pfizer Inc., Labeling Revision
- Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Sepracor Inc., Control Supp.
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
1-888-INFO-FDA (1-888-463-6332)
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FDA MedWatch- Chattem Icy Hot Heat Therapy Products- Nationwide Recall Due To Reports of First, Second And Third Degree Burns
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Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:
Icy Hot Heat Therapy Air Activated Heat - Back
Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg single consumer use "samples" on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream
Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer.
Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chattem
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CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | Date: February 11, 2008 |
The following new items were added to the CDRH web pages on February 8, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System |  |  |
| FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008 | |
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