MEDICAL RECALLS.........many

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System:
ISSUE: The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating infrequent rates of false negative MRSA results, which could result in incorrect treatment or delay of care for patients with MRSA infection.
BACKGROUND: This test is used to detect methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from patient positive blood culture determined to be Gram Positive Cocci in Clusters (GPCC) or Gram Positive Cocci in singles (GPC) by Gram stain.

RECOMMENDATION: On July 1, 2010, the company issued a press release and sent its customers a revised Corrective Action Notice letter instructing them not to report the MRSA negative result when a MRSA negative/SA positive result is generated on the Cepheid MRSA/SA Blood Culture Assay. Instead, customers were instructed to conduct further antimicrobial susceptibility testing to determine the MRSA result. The MRSA positive/SA positive results generated on the Cepheid MRSA/SA Blood Culture Assay can still be reported. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218038.htm

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Slim-30 Herb Supplement: Undeclared Drug Ingredient

ISSUE: FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown. This product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

BACKGROUND: Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/code being recalled is 032009. The product was sold to distributors and retail stores nationwide and China and via internet sales. No illnesses or injuries have been reported to the company to date in connection with this product.

RECOMMENDATION: Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm219463.htm

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Que She Herbal Supplement: Undeclared Drug Ingredients
Capsules widely sold on Internet sites as weight loss supplement
ISSUE: FDA warned consumers and healthcare professionals that Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

BACKGROUND: Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas.

FDA analysis of Que She found that it contains:

fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage
propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions
sibutramine – a controlled substance and prescription weight loss drug, sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease
ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm218439.htm

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Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk
ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer.

BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.

The meta-analysis included data from over 1,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.

The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm219185.htm

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LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

ISSUE: A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm217980.htm

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Coumadin 1 mg Tablet Blister Packs: Recall
Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding.
ISSUE: The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
BACKGROUND: The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm218955.htm

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Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. FDA previously required a Boxed Warning stating that leflunomide was contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception.

BACKGROUND: The decision to add information on severe liver injury to the Boxed Warning was based on FDA’s review of adverse event reports which identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, between August 2002 and May 2009. In this review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease.

RECOMMENDATIONS: The information on severe liver injury being added to the Boxed Warning states:




Patients with pre-existing liver disease should not receive leflunomide.
Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive leflunomide.
Caution should be used in patients who are taking other drugs that can cause liver injury.
Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter.
If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide – leflunomide should be stopped, cholestryamine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm218912.htm

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CONSTELLATION Vision System: Recall

ISSUE: Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.

BACKGROUND: The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery. All model and catalog numbers are affected by this recall and are listed in the FDA Recall Notice. These devices were manufactured and distributed from September 1, 2008 through April 30, 2010. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts

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Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
ISSUE: FDA has received reports of air or gas embolism occurring during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers. These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site. Although rare, the reports describe air embolisms that are life threatening and include one fatality.
BACKGROUND: The manufacturers of all fibrin sealants licensed in the U.S. have updated the Warning and Precautions sections of the labels of EVICEL, Tisseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance. The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.

RECOMMENDATIONS: Clinicians using air- or gas-pressurized spray devices for application of hemostatic drug or biological products should:


Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use of the hemostatic agent.
Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
Monitor blood pressure, pulse, oxygen saturation and end tidal CO2 for signs of an air or gas embolism.
Make sure the regulators are maintained properly and checked for safe performance regularly.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm218530.htm

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Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
ISSUE: Due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death.

BACKGROUND: Qualaquin is only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas. However, the majority of Qualaquin's use in the United States is for the treatment or prevention of night time leg cramps.The product labeling states that the risks associated with the use of Qualaquin in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.

The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions.

RECOMMENDATION: Healthcare professionals should discuss with patients the warning signs of thrombocytopenia, such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin. Patients are encouraged to read the Medication Guide given to them at the pharmacy before starting Qualaquin and each time they get a refill. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts


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Vialipro Dietary Supplement: Recall- Undeclared Drug Ingredient ISSUE: Good Health, Inc. is conducting a voluntary recall after an FDA lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm219580.htm

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Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning
ISSUE: Certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

The lot numbers, doses, and quantities of the stolen Advair Diskus inhalers are:

Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose, Exp: Sep 2010 (14,400 inhalers)
Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose, Exp: Sep 2010 (11,200 inhalers)
BACKGROUND: Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhaler used to treat patients with asthma and chronic obstructive pulmonary disease. The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in commerce. However, more stolen product may still be on the market and the FDA continues to aggressively investigate the matter.

RECOMMENDATION: Patients who have products with these lot numbers should immediately stop using them, contact GlaxoSmithKline’s Customer Response Center at 888-825-5249, and follow-up with their physician or pharmacist to obtain a proper replacement.

Pharmacists and wholesalers who find Advair Diskus inhalers bearing these lot numbers should remove them from shelves and contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989. The agency also is asking for the public's help in reporting any information regarding these inhalers, including suspicious or unsolicited offers for the Advair Diskus lots in question, to OCI or by visiting the OCI website. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts

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Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of children and pets to topical estrogen ISSUE: FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce hot flashes during menopause. Children unintentionally exposed to the drug through skin contact with women may experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.
BACKGROUND: Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. FDA is currently reviewing reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure. The Agency will update the public when this review is complete. FDA and the company are also evaluating ways to minimize the risk.

RECOMMENDATION: Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman MedicalProducts

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Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

ISSUE: FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed.

BACKGROUND: FDA has reviewed published case reports of Cubicin-associated eosinophilic pneumonia and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System. FDA's review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin. Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

RECOMMENDATION: Healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm220499.htm

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Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and trays. Sets and Trays contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube
Issue: FDA notified healthcare professionals that Cook initiated a voluntary recall of certain lots of Ciaglia Blue Rhino/Blue Dolphin Percutaneous Tracheostomy Introducer
Sets/Trays that contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube due to the product’s cuff not holding air. The voluntary recall only affects lot numbers noted in the press release at link below.

Background: The defect is a result of leaks in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation and could result in serious injury, including death.

Recommendation: Cook has mailed a detailed Customer Notification letter to each customer who has received an affected lot number of these devices. Customers should review product in inventory and current use to identify product from the affected lot codes. Healthcare professionals may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online by regular mail or fax. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts

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Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.
BACKGROUND: MMS is distributed on Internet sites and online auctions by multiple independent distributors. MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

RECOMMENDATIONS: Consumers who have MMS should stop using it immediately and throw it away. The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts

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Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile seizure

ISSUE: FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

BACKGROUND: FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

The available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure. FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.

RECOMMENDATION: Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (“shot”) forms. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year. Therefore, it is important to get the influenza vaccine every year. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts

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Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient ISSUE: FDA notified consumers that lab analysis of lots of ejaculoid XXTREME and stimuloid II found that the products, sold as dietary supplements, contain sulfoaildenafil, similar to sildenafil, which is an active ingredient of an FDA-approved drug for male erectile dysfunction, making these products unapproved drugs. This active drug ingredient is not listed on the product labels and may interact with nitrates found in drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

BACKGROUND: The recalled products were distributed in black plastic bottles to distributors and via internet sales. The company press release contains specific lot numbers and additional recall information. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuman MedicalProducts

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GammaGard Liquid, Immune Globulin Intravenous (Human)
Baxter BioScience and FDA notified healthcare professionals of a market withdrawal being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with two lots of the product.

GammaGard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. See the Market Withdrawal Notice for information on affected lots. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm214497.htm