http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a4.htm?s_cid=mm6006a4_w

Update: Influenza Activity — United States, October 3, 2010–February 5, 2011

MMWR WeeklyFebruary 18, 2011 / 60(06);175-181

This report summarizes U.S. influenza activity* since the beginning of the 2010–11 influenza season (October 3, 2010) and updates the previous report (1). From October through early December 2010, influenza activity remained low in most regions of the United States. Activity increased beginning in mid-December 2010 and continued to increase during January and early February 2011. Influenza B, 2009 influenza A (H1N1), and influenza A (H3N2) viruses all have been identified thus far this influenza season, and most viruses in circulation are antigenically similar to strains included in the 2010–11 vaccine.

Viral Surveillance

During October 3, 2010–February 5, 2011, approximately 140 World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories in the United States tested 116,255 respiratory specimens for influenza viruses; 22,641 (19.5%) were positive (Figure 1). Of these, 16,496 (73%) were influenza A viruses, and 6,145 (27%) were influenza B viruses. A total of 11,094 (67%) of the influenza A viruses were subtyped; 7,845 (71%) were influenza A (H3) viruses, and 3,249 (29%) were 2009 influenza A (H1) viruses.

Influenza virus–positive test results have been reported from all 50 states and the District of Columbia. The percentage of specimens testing positive for influenza first exceeded 10% during the week ending November 27, 2010, increased through the week ending January 29, 2011, when 34% of specimens tested positive, and decreased slightly in the week ending February 5, 2011, when 32% of specimens tested positive.

Although influenza A (H3N2) viruses have predominated this season, 2009 influenza A (H1N1) and B viruses also have circulated widely. The relative proportion of each type or subtype has varied by date and U.S. Department of Health and Human Services region.† From early November through mid-December, influenza B viruses accounted for 40%–49% of influenza viruses reported in the United States, with the largest numbers reported from Region 4, the southeastern states. Influenza B viruses were predominant in Region 4 through the end of December. During November and December, influenza A viruses predominated in all other regions and have predominated in all regions during January and early February. More than 80% of subtyped influenza A viruses from November and December were A (H3N2). However, the proportion of 2009 influenza A (H1N1) viruses began to increase during January and accounted for 50% of all subtyped influenza A viruses for the week ending February 5, 2011.

Outpatient Illness Surveillance

Since October 3, 2010, the weekly percentage of outpatient visits for influenza-like illness (ILI)§ reported by approximately 1,700 U.S. Outpatient ILI Surveillance Network (ILINet) providers in 50 states, New York City, Chicago, and the District of Columbia that comprise ILINet has ranged from 1.1% to 4.6%. Since December 19, 2010, the percentage has exceeded the national baseline of 2.5% (Figure 2). On a regional level,¶ the percentage of outpatient visits for ILI ranged from 1.8% to 7.3% during the week ending February 5, 2011. Nine of the 10 regions (Regions 1–8 and 10) reported ILI above region-specific baseline levels. Data collected in ILINet are used to produce a measure of ILI activity** by state. During the week ending February 5, 2011, 19 states (Alabama, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Mississippi, Missouri, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia) experienced high ILI activity, nine states experienced moderate ILI activity, New York City and 10 states experienced low ILI activity, 12 states experienced minimal ILI activity, and data from the District of Columbia were insufficient to calculate an ILI activity level.

State-Specific Levels of Influenza Activity

For the week ending February 5, 2011, the level of influenza activity†† was reported as widespread by 37 states and regional in nine states. The District of Columbia reported local activity, and four states, as well as Puerto Rico, Guam, and the U.S. Virgin Islands, reported sporadic activity.

Widespread influenza activity was first reported in Georgia during the week ending December 18; an additional 13 states reported regional spread of influenza activity for that week. By the week ending January 22, widespread influenza activity had been reported by at least one state in each region.

Influenza-Associated Hospitalizations

CDC monitors hospitalizations associated with laboratory-confirmed influenza infections using the FluSurv-NET surveillance system. FluSurv-NET§§ is a population-based surveillance network that was created during the 2009–10 influenza season, when surveillance in six states was added to ongoing surveillance for influenza-associated hospitalizations in the 10 Emerging Infections Program (EIP) states. Based on EIP surveillance data, the cumulative hospitalization rate (per 100,000 population) for October 3, 2010–February 5, 2011, was 14.5 among children aged 0–4 years, 2.5 among children aged 5–17 years, 3.5 among adults aged 18–49 years, 6.3 among adults aged 50–64 years, and 18.8 among adults aged ≥65 years. The cumulative incidence for all age groups since October 3, 2010, was 6.3 per 100,000. Based on FluSurv-NET data, the cumulative hospitalization rate (per 100,000) for October 3, 2010–February 5, 2011, was 18.5 among children aged 0–4 years, 3.2 among children aged 5–17 years, 4.2 among adults aged 18–49 years, 7.5 among adults aged 50–64 years, and 21.3 among adults aged ≥65 years. The cumulative incidence for all age groups since October 3, 2010, was 7.6 per 100,000 (Figure 3).

As of February 5, 2011, among the 628 FluSurv-NET adult patients for whom medical chart data were available for analysis, the most frequent underlying conditions were metabolic disorders (32%), cardiovascular disease (30%), and asthma or reactive airway disease (19%). Among 226 children hospitalized with laboratory-confirmed influenza, 47% did not have any underlying conditions, and 20% had underlying asthma or reactive airway disease.

Pneumonia and Influenza-Related Mortality

For the week ending February 5, 2011, pneumonia and influenza (P&I) was reported as an underlying or contributing cause of death for 8.0% of all deaths reported to the 122 Cities Mortality Reporting System. This percentage is at the epidemic threshold of 7.97% for that week.¶¶ Since October 3, 2010, the weekly percentage of deaths attributed to P&I ranged from 6.0% to 8.4%, and first exceeded the epidemic threshold during the week ending January 29, 2011 (Figure 4). Peak weekly percentages of deaths attributed to P&I previously were as follows: 8.2 for the week ending January 23, 2010, during the 2009–10 season; 7.9 for the week ending April 11, 2009, during the 2008–09 season; 9.1% for the week ending March 15, 2008, during the 2007–08 season; and 7.7% for the week ending February 24, 2007, during the 2006–07 season.

Influenza-Related Pediatric Mortality

As of February 5, 2011, a total of 30 influenza-related pediatric deaths from 18 states (Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Texas, Utah, Virginia, and West Virginia) and New York City have been reported to CDC for the 2010–11 season. Nine deaths were associated with influenza A (H3N2) virus infection, 12 deaths were associated with influenza B virus infection, three deaths were associated with influenza A (H1N1), and six were associated with an influenza A virus for which the subtype was not determined. Twenty of these deaths occurred during January 16–February 5, 2011. During the 2009 pandemic, 329 pediatric deaths were reported during April 15, 2009–January 23, 2010. Before the pandemic, 65 influenza-related pediatric deaths were reported for the 2008–09 season (through the week ending April 11, 2009), 88 pediatric deaths were reported for the 2007–08 season, and 77 pediatric deaths were reported for the 2006–07 season.

Antigenic Characterization

WHO collaborating laboratories in the United States are requested to submit a subset of their influenza-positive respiratory specimens to CDC for further antigenic characterization. Since October 1, 2010, CDC has antigenically characterized 564 influenza viruses submitted by U.S. laboratories: 82 were 2009 influenza A (H1N1), 300 influenza A (H3N2), and 182 influenza B viruses. All 82 of the 2009 influenza A (H1N1) viruses were characterized as A/California/7/2009-like, the influenza A (H1N1) component of the 2010–11 influenza vaccine. Of 300 influenza A (H3N2) viruses, 298 (99%) were characterized as A/Perth/16/2009-like, the influenza A (H3N2) component of the 2010–11 influenza vaccine. Two viruses (1%) of the 300 tested showed reduced titers with antiserum produced against A/Perth/16/2009. Of the 182 influenza B viruses tested, 170 (93%) belong to the B/Victoria lineage of viruses: 169 (99.4%) were characterized as B/Brisbane/60/2008-like, the recommended influenza B component for the 2010–11 influenza vaccine, and one (0.6%) showed reduced titers with antisera produced against B/Brisbane/60/2008. Twelve (7.0%) of the 182 influenza B viruses were identified as belonging to the B/Yamagata lineage of viruses.

Novel Influenza A Viruses

Four cases of human infection with a novel influenza A virus have been reported this influenza season. Three cases were reported during November and December 2010 and are described in a previous update (1). On January 25, 2011, a fourth case of human infection with swine origin influenza A (H3N2) was identified in a female child in Pennsylvania. She developed symptoms of fever, headache, and lethargy on September 6, 2010. She did not require hospitalization and has since fully recovered. The patient reported contact with swine in the week preceding symptom onset.

Antiviral Resistance of Influenza Virus Isolates

Since October 1, 2010, a total of 364 influenza virus isolates have been tested for antiviral resistance. Of the 158 influenza A (H3N2) and 119 influenza B viruses tested, 100% were sensitive to both oseltamivir and zanamivir. Among the 2009 influenza A (H1N1) viruses, the 87 tested for resistance to oseltamivir were 100% sensitive, and the 33 tested for resistance to zanamavir were 100% sensitive. High levels of resistance to the adamantanes (amantadine and rimantadine) persist among 2009 influenza A (H1N1) and A (H3N2) viruses currently circulating.

Editorial Note

Influenza activity, as measured across all CDC influenza surveillance systems in the United States, began to increase in mid-December and continued to increase through the week ending February 5, 2011. Although the timing of peak activity is not predictable, peak activity in the United States most commonly occurs in February; however, substantial activity can occur as late as May (2). Vaccination remains the most effective method to prevent influenza and its complications. Health-care providers should continue to offer vaccine to all unvaccinated persons aged ≥6 months throughout the influenza season.

Influenza A (H3N2), 2009 A (H1N1), and B viruses have cocirculated this influenza season, with the predominant influenza virus varying over time and by region. Influenza A (H3N2) has been the predominant influenza virus in circulation in all regions except Region 4, where influenza B predominated early in the season. Although a small number of 2009 influenza A (H1N1) viruses were found to be circulating early in the season, the proportion of influenza A viruses that are 2009 influenza A (H1N1) has increased over the past few weeks in several regions. Thus far this season, all of the 2009 influenza A (H1N1) viruses and the majority of influenza A (H3N2) and B viruses in circulation that were tested are closely related to components included in the 2010–11 influenza vaccine.

According to 2010 recommendations of the Advisory Committee on Immunization Practices (ACIP), health-care providers should offer influenza vaccination to all persons aged ≥6 months throughout the influenza season (2). All children aged 6 months–8 years who receive a seasonal influenza vaccine for the first time should receive 2 doses. Children who received only 1 dose of a seasonal influenza vaccine in the first influenza season that they were vaccinated should receive 2 doses in the following influenza season. In addition, for the 2010–11 influenza season, children aged 6 months–8 years who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine should receive 2 doses of a 2010–11 seasonal influenza vaccine, regardless of previous vaccination history (2).

Higher overall and age-specific rates of hospitalization often are observed during influenza A (H3N2)–predominant seasons (3). Based on FluSurv-NET surveillance data thus far, rates of hospitalization among patients with laboratory-confirmed influenza are increasing. Rates of influenza-associated hospitalization are highest in children aged 0–4 years and adults aged ≥65 years. This trend is similar to that seen in 2007–08, the last season in which influenza A (H3N2) was predominant. In influenza seasons before the 2009 pandemic, cumulative end-of-season hospitalization rates per 100,000 persons obtained from EIP surveillance data ranged from 7.7 in 2008–09 to 18.1 in 2007–08.

Since the beginning of this season, 30 influenza-related pediatric deaths have been reported. More than half of the pediatric deaths this season have occurred since January 16, 2011. Health-care providers are asked to notify their local or state health department as soon as possible when deaths associated with laboratory-confirmed influenza occur among children.

Antiviral medications continue to be an important adjunct to vaccination for reducing the health impact of influenza. On January 21, 2011, new ACIP recommendations on use of antiviral agents for treatment and chemoprophylaxis of influenza were released (4). Antiviral treatment is recommended as soon as possible for patients with confirmed or suspected influenza who have severe, complicated, or progressive illness; who require hospitalization, or who are at higher risk for influenza complications (4–7). Antiviral treatment also may be considered for outpatients with confirmed or suspected influenza who do not have known risk factors for severe illness if treatment can be initiated within 48 hours of illness onset. Recommended antiviral medications include oseltamivir and zanamivir; recent viral surveillance and resistance data indicate that >99% of currently circulating influenza virus strains are sensitive to these medications. Amantadine and rimantadine should not be used because of the high levels of resistance to these drugs among circulating influenza A viruses (4).

Influenza surveillance reports for the United States are posted online weekly during October–May and are available at http://www.cdc.gov/flu/weekly/fluactivity.htm. Additional information regarding influenza viruses, influenza surveillance, influenza vaccine, influenza antiviral medications, and novel influenza A infections in humans is available at http://www.cdc.gov/flu.

Acknowledgments

This report is based, in part, on data contributed by participating state and territorial health departments and state public health laboratories, World Health Organization collaborating laboratories, National Respiratory and Enteric Virus Surveillance System collaborating laboratories, the U.S. Outpatient ILI Surveillance Network, the Aggregate Hospitalization and Death Reporting Activity, the Influenza Associated Pediatric Mortality Surveillance System, and the 122 Cities Mortality Reporting System.

References

1. CDC. Update: influenza activity—United States, October 3, 2010–December 11, 2011.MMWR 2010;59:1651–5.
2. CDC. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2010;59(No. RR-8).
3. Dao CN, Kamimoto L, Nowell M, et al. Adult hospitalizations for laboratory-positive influenza during the 2005–2006 through 2007–2008 seasons in the United States. J Infect Dis 2010;202:881–8.
4. CDC. Antiviral agents for the treatment and chemoprophylaxis of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60(No. RR-1):1–24.
5. CDC. Deaths related to 2009 pandemic influenza A (H1N1) among American Indian/Alaska Natives—12 states, 2009. MMWR 2009;58:1341–4.
6. Jain S, Kamimoto L, Bramley AM, et al. Hospitalized patients with 2009 H1N1 influenza in the United States, April–June 2009. N Engl J Med 2009;361:1935–44.
7. Morgan OW, Bramley A, Fowlkes A, et al. Morbid obesity as a risk factor for hospitalization and death due to 2009 pandemic influenza A(H1N1) disease. PLoS ONE 2010; 5:e9694.

http://www.fda.gov/Drugs/DrugSafety/ucm243539.htm

FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor

[02-17-2011] The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.
 

Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor. 
 

Although it may be clinically deemed appropriate based on the healthcare professional’s judgment to administer terbutaline by injection in urgent and individual obstetrical situations in a hospital setting, the prolonged use of this drug to prevent recurrent preterm labor can result in maternal heart problems and death. Terbutaline should not be used in the outpatient or home setting.
 

The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information received and reviewed by the FDA. Specifically, FDA has reviewed postmarketing safety reports of terbutaline used for obstetrical indications (see Data Summary below), as well as data from the medical literature.^1-6 These label changes are consistent with statements from the American College of Obstetricians and Gynecologists (ACOG).⁶

Additional Information for Patients

• Be aware that serious side effects, including maternal heart problems and death, have been reported after prolonged use of terbutaline to manage preterm labor.
• There are serious situations where a healthcare professional may decide that the short-term use of injectable terbutaline in the hospital setting may benefit a pregnant woman.
• Oral terbutaline should not be used either to treat preterm labor or prevent recurrent preterm labor.
• If you are taking terbutaline for another medical condition (e.g., asthma), talk to your healthcare professional if you are pregnant or become pregnant to determine whether terbutaline is still right for you.
• FDA encourages patients to talk to their healthcare professional if they have concerns about any treatment they are receiving.
• Report any side effects from the use of oral or injectable terbutaline to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

Additional Information for Healthcare Professionals

• Be aware that death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.
• Treatment with terbutaline administered by injection or by continuous infusion pump should not be used beyond 48 to 72 hours. In particular, injectable terbutaline should not be used in the outpatient or home setting.
• There are certain obstetrical conditions where the healthcare professional may decide that the benefit of terbutaline injection for an individual patient in a hospital setting clearly outweighs the risk.
• Oral terbutaline is contraindicated for the treatment or prevention of preterm labor.
• Report adverse events involving terbutaline to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.

Data Summary

In November 1997, FDA issued a Dear Colleague letter to notify healthcare professionals about concerns regarding the safety of long-term subcutaneous administration of terbutaline. The Precautions section of the labeling was revised to warn about serious adverse reactions, including cardiovascular adverse events that may occur after administration of terbutaline to women in labor. 

Publications in the medical literature have reported a lack of safety and efficacy of terbutaline for the treatment of recurrent preterm labor.^2-5 Despite labeling changes, FDA’s communication to the public, and professional association recommendations, prolonged use of terbutaline continues, with serious and sometimes fatal consequences. 

FDA reviewed postmarketing reports of maternal death and serious cardiovascular adverse events submitted to the Adverse Event Reporting System (AERS) associated with obstetric use of terbutaline. 

A search of AERS identified 16 maternal deaths that were reported since initial marketing of the drug in 1976 until 2009. Three of the 16 cases reported outpatient use of terbutaline administered by a subcutaneous pump, while nine cases reported use of oral terbutaline alone or in addition to subcutaneous or intravenous terbutaline. Of these nine cases, two reported use of oral terbutaline on an outpatient basis and seven cases involved inpatient use of oral terbutaline. The routes of administration in the remaining four cases were subcutaneous, intravenous, or unknown. 

FDA identified 12 maternal cases of serious cardiovascular events associated with use of terbutaline that were reported to AERS between January 1, 1998 (after FDA issued the Dear Colleague letter) and July 2009. These events included cardiac arrhythmias, myocardial infarction, pulmonary edema, hypertension, and tachycardia. Three of the 12 cases reported use of the terbutaline administered by subcutaneous pump. Five cases involved use of oral terbutaline alone or in addition to subcutaneous terbutaline. Of these five cases, three cases involved use of oral terbutaline on an outpatient basis and two cases involved inpatient use of oral terbutaline. 

In summary, based on this information, FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.

References

1. National Asthma Education and Prevention Program (NAEPP). Working Group Report on Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment—Update 2004. NIH Publication No. 05-5236. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute, 2004. Available from: http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg/astpreg_full.pdf¹. Accessed November 19, 2010.

2. Wenstrom KD, Weiner CP, Merrill D, et al. A placebo-controlled randomized trial of the terbutaline pump for prevention of preterm delivery. Am J Perinatol. 1997;14:87-91.

3. Guinn DA, Goepfert AR, Owen J, et al. Terbutaline pump maintenance therapy for prevention of preterm delivery: a double-blind trial. Am J Obstet Gynecol. 1998;179:874-878.

4. Sanchez-Ramos L, Kaunitz AM, Gaudier FL, et al. Efficacy of maintenance therapy after acute tocolysis: a meta-analysis. Am J Obstet Gynecol. 1999;181:484-490.

5. Berkman ND, Thorp JM, Lohr KN, et al. Tocolytic treatment for the management of preterm labor: a review of the evidence. Am J Obstet Gynecol. 2003;188:1648-1659.

6. American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologist. No. 43. Management of preterm labor. Obstet Gynecol. 2003;101:1039-1047.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243686.htm

Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall

[Posted 2/16/2011]

AUDIENCE: Hospital Risk Manager

ISSUE: Pocket fills (the unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump) may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
Products Affected:

• SynchroMed II (Model No: 8637)
• SynchroMed EL (Model No: 8626 and 8627)
• Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, and 8566)

BACKGROUND: The SynchroMed II Programmable Pump and the SynchroMed EL Infusion System are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient’s body. The Medtronic refill kit is used in refilling Medtronic implantable infusion pumps, with the exception of Medtronic MiniMed Infusion Pumps.

RECOMMENDATION: Medtronic reminded healthcare professionals to check needle placement within the pump septum during the drug refill procedure. According to Medtronic, it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir. At every refill, patients and caregivers should be reminded about the signs and symptoms of drug overdose, underdose, and withdrawal.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243552.htm

Triad Sterile Lubricating Jelly: Recall – Product May Not Be Sterile

Product may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms, including brand names Allegiance, Select Medical Products, Novaplus, Triad, Triad Plus, IMCO, McKesson Medi-Pak Performance, Henry Schein

[Posted 02/16/2011]

AUDIENCE: Risk Manager

ISSUE: These products may not be sterile. Patients who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.

BACKGROUND: Triad lubricating jelly products were distributed by Triad from January, 2007 through December 2010. These products may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms.

RECOMMENDATION: Immediately contact your kit, pack or tray suppliers to determine whether the products stocked at your facility are impacted by the Triad recall. Your supplier should provide you with documentation on whether your products are affected by the recall.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹
• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

http://www.medscape.com/viewarticle/737424?src=emailthis

Pauline Anderson

Pauline Anderson is a freelance writer for Medscape.

From Medscape Medical News

Research on Botulinum Toxin for Migraine ‘Unconvincing’

Pauline Anderson

February 15, 2011 — “Despite botulinum toxin A (Botox) being approved in the United States and the United Kingdom for use in chronic migraines, published evidence on the effectiveness of this treatment for headaches is limited and unconvincing, according to an article appearing in Drug and Therapeutic Bulletin (DTB), which is affiliated with the BMJ……”

The “Superhero Cape Burrito”: A Simple and Comfortable Method of Short-term
Procedural Restraint
Published online: 08 February 2011
Julie C. Brown, Eileen J. Klein
DOI: 10.1016/j.jemermed.2010.11.024
Journal of Emergency Medicine

Link:  http://www.jem-journal.com/article/S0736-4679%2810%2900906-6/abstract

Treatment of Laryngeal Hereditary Angioedema
Published online: 14 February 2011
Mark J. Richman, David A. Talan, William R. Lumry
DOI: 10.1016/j.jemermed.2010.11.032
Journal of Emergency Medicine

http://www.jem-journal.com/article/S0736-4679%2810%2901000-0/abstract

http://www.boston.com/lifestyle/health/articles/2011/02/13/patient_alarms_often_unheard_unheeded/

Boston Globe

Patient alarms often unheard, unheeded

The incessant din of beeping monitors can numb or distract hospital staff; the consequences can be deadly

By Liz Kowalczyk Globe Staff / February 13, 2011

“…..They call it “alarm fatigue.’’ Monitors help save lives, by alerting doctors and nurses that a patient is — or soon could be — in trouble. But with the use of monitors rising, their beeps can become so relentless, and false alarms so numerous, that nurses become desensitized — sometimes leaving patients to die without anyone rushing to their bedside….”

http://www.nytimes.com/2011/02/11/us/11smoking.html?_r=1&nl=todaysheadlines&emc=tha23

NY Times

By A. G. SULZBERGER

http://www.medpagetoday.com/PrimaryCare/PreventiveCare/24758

FDA Mulls Health Warning on Powdered Gloves

By John Gever, Senior Editor, MedPage Today
Published: February 08, 2011

“Health risks associated with powdered medical gloves — for professionals as well as patients — may soon be highlighted on their packages, according to the FDA.  In a draft guidance document for manufacturers, the FDA proposed that powdered surgical and patient examination gloves carry a warning that the products may cause health problems ranging from latex allergies to granulomas and adhesions in patients……”

Prochlorperazine in children with migraine: a look at its effectiveness and rate
of akathisia
Published online: 07 February 2011
Evelyne D. Trottier, Benoit Bailey, Nathalie Lucas, Anne Lortie
DOI: 10.1016/j.ajem.2010.12.020
American Journal of Emergency Medicine, The,

http://www.ajemjournal.com/article/S0735-6757%2810%2900604-2/abstract

Delayed diagnosis of injuries in pediatric trauma: the role of radiographic
ordering practices
Published online: 07 February 2011
Emily L. Willner, Hollie A. Jackson, Alan L. Nager
DOI: 10.1016/j.ajem.2010.10.033
American Journal of Emergency Medicine

http://www.ajemjournal.com/article/S0735-6757%2810%2900540-1/abstract

http://www.fda.gov/Safety/Recalls/ucm242398.htm

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 MG / 500 MG, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E And T023M10A And Phenobarbital Tablets, USP 32.4 MG, NDC 0603-5166-32, 1000 Count, Lot Numbers T150G10B, T120J10E And T023M10A

Contact:
Consumers
800-444-4011

Media
Kevin Wiggins
610-459-7281

Investors/Media
Blaine Davis
610-459-7158

FOR IMMEDIATE RELEASE – February 5, 2011 – Qualitest Pharmaceuticals today issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.

As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.

No injuries have been reported to date.

Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.

The recall includes the following products:

• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
• Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

These lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico). Lot numbers can be found on the side of the bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are large (approximately 16.5 mm in length), pink, capsule-shaped tablets, debossed (3600) on one side, and debossed (V) on the reverse side; Phenobarbital Tablets are small (approximately 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Phenobarbitol manufactured by Qualitest, are asked to double check the identity of their tablets.

Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.

• Telephone: 1-800-444-4011
• Online: http://www.fda.gov/MedWatch/report.htm⁹
• Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm¹⁰ Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com¹¹).

http://www.fda.gov/Safety/Recalls/ucm242331.htm

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot# 0048 Due to Translucent Visible Particles

Contact:
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
631-924-4000

Customer/Professional Service Departments
877-788-3232

FOR IMMEDIATE RELEASE – February 3, 2011 – American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:

Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium
5 mL Single Dose Vial
NDC # 0517-2305-25
Lot #0048
Exp Date: January, 2012

PLEASE NOTE: This recall, initiated on February 3, 2011 to the User or Consumer Level, is for lot # 0048 Only. No other lots or sizes of Potassium Phosphates Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Potassium Phosphates Injection, USP, 3 mM Phosphorus/mL, is indicated as a source of phosphorus, for addition to large volume intravenous fluids to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent, Inc., Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, with lot # 0048 for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EST.

Hospitals, Home Health Agencies, Emergency Rooms, Infusion Centers, Clinics and Healthcare Providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email at pv@luitpold.com by fax to (610) 650-7781 or (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, or regular mail or by fax.

• Online:http://www.fda.gov/MedWatch/report.htm⁹
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm¹⁰ . Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

“All of us at American Regent and Luitpold are taking the necessary steps to protect patients from any potential safety risks with our Potassium Phosphates Injection. The safety and well being of patients receiving our products is our primary concern,” said Mary Jane Helenek, President and CEO of American Regent.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Potassium Phosphates Injection, USP, Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

Potassium Phosphates Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

Source: Luitpold Pharmaceuticals, Inc.

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.