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FDA Medwatch Alert: Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution: Recall - Inadequate Seal of Blister Pack

Posted 18 Aug 2016 by Drugs.com

ISSUE: Arbor  Pharmaceuticals, LLC announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack. The improper seal of the product can lead to a potentially sub-therapeutic dose as well as potential microbial contamination. Because the effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen is delayed with decreased therapy, sub-therapeutic dosing could lead to increased risk of liver injury. With regards to the potential microbial contamination due to moisture ingress into the tablets, the risk ... Read more

Related support groups: Acetylcysteine, Acetaminophen Overdose, Cetylev

Depression Plagues Many With COPD

Posted 17 Jun 2016 by Drugs.com

FRIDAY, June 17, 2016 – Struggling with chronic obstructive pulmonary disorder (COPD) may raise the risk of depression among patients with the incurable respiratory illness, two new studies suggest. One report, from scientists at Manchester Metropolitan University in England, found one in four patients with COPD suffered persistent depressive symptoms over the three years of the study. If untreated, depression can have a negative effect on the patients' overall health and the effectiveness of their treatment, the researchers noted. A second study from the University of Texas analyzed data from a random sample of 5 percent of Medicare beneficiaries diagnosed with COPD between 2001 and 2011. The researchers found that 22 percent of those patients had one or more psychological disorders. The study also showed that the odds of 30-day readmission to the hospital were higher in patients with ... Read more

Related support groups: Depression, Major Depressive Disorder, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Maintenance, Fluticasone, Dysthymia, Ribavirin, Qvar, Flovent, Budesonide, Seasonal Affective Disorder, Entocort, Tobramycin, Mometasone, Chronic Obstructive Pulmonary Disease, Acute, Entocort EC, Acetylcysteine, Beclomethasone, Mucomyst, Pulmicort Flexhaler

Health Tip: Control Asthma

Posted 7 Jun 2016 by Drugs.com

-- Asthma medications can tame your symptoms and greatly improve your quality of life. The U.S. Centers for Disease Control and Prevention says benefits of controlling asthma include: Better breathing. Regaining the ability to participate in sports and other physical activities. Better sleep. Freedom from wheezing and coughing. Avoiding hospital stays. Read more

Related support groups: Asthma, Asthma - Maintenance, Fluticasone, Asthma - Acute, Qvar, Ribavirin, Flovent, Budesonide, Entocort, Tobramycin, Mometasone, Entocort EC, Acetylcysteine, Mucomyst, Beclomethasone, Pulmicort Flexhaler, Alvesco, Uceris, Asmanex Twisthaler, Pulmicort Turbuhaler

Many Parents Ill-Informed About Kids' Asthma Meds

Posted 31 May 2016 by Drugs.com

TUESDAY, May 31, 2016 – Only half of parents of children with asthma fully understand the use of their youngsters' asthma medications, a new study finds. A survey of parents of 740 children with probable persistent asthma found just 49 percent knew what kind of medication their child was prescribed and how often to use it. Following recommended guidelines is key to controlling asthma symptoms, experts say. "Adherence to the guidelines has demonstrated improved outcomes: decreased hospitalizations, emergency department visits and outpatient visits," said study primary author Dr. Ann Chen Wu, of the Harvard Pilgrim Health Care Institute in Boston. Parents were asked which asthma controller medications their child was prescribed and how often they should be taken. Responses were compared to instructions from their child's health care provider. Records showed that 77 percent of the ... Read more

Related support groups: Asthma, Asthma - Maintenance, Fluticasone, Asthma - Acute, Qvar, Ribavirin, Flovent, Budesonide, Entocort, Tobramycin, Mometasone, Entocort EC, Acetylcysteine, Mucomyst, Beclomethasone, Pulmicort Flexhaler, Alvesco, Uceris, Asmanex Twisthaler, Pulmicort Turbuhaler

Fewer Inhaled Steroids May Be OK for Asthmatic Children

Posted 27 May 2016 by Drugs.com

FRIDAY, May 27, 2016 – Inhaled steroid therapy is commonly used to treat asthmatic children with persistent, daily wheezing episodes. However, a new study suggests that the powerful medicines may not be needed on a daily basis for kids whose wheezing occurs sporadically, such as when they catch a cold. "It makes sense that these children with frequent symptoms require daily treatment, whereas those who wheeze just during viral illnesses may only need treatment during illnesses," study lead author Dr. Sunitha Kaiser, of the University of California, San Francisco, said in a university news release. Two experts who reviewed the study had different reactions to the findings, however. "The less-frequent use of steroids is good news for children, since chronic steroid use can stunt growth," said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City. Child asthma ... Read more

Related support groups: Asthma, Symbicort, Asthma - Maintenance, Fluticasone, Flonase, Advair Diskus, Advair HFA, Asthma - Acute, Qvar, Flovent, Budesonide, Entocort, Mometasone, Breo Ellipta, Entocort EC, Veramyst, Acetylcysteine, Mucomyst, Beclomethasone, Pulmicort Flexhaler

Health Tip: Create an Asthma Action Plan

Posted 16 May 2016 by Drugs.com

-- An asthma action plan can help people with asthma handle an attack quickly and safely. The U.S. Centers for Disease Control and Prevention recommends: Creating the action plan with your doctor's assistance. Including in your plan the asthma treatments taken daily, including the type of medications and when taken. Including a plan for long-term asthma control. Including a plan for an asthma attack. Noting when it's appropriate to visit the doctor or go to the emergency room. If the plan is for a child, giving the plan to anyone who cares for that child, including daycare providers and teachers. Read more

Related support groups: Asthma, Albuterol, Asthma - Maintenance, Ventolin, Fluticasone, Asthma - Acute, Qvar, Ribavirin, Combivent, Flovent, Budesonide, Entocort, Tobramycin, ProAir HFA, Mometasone, Proventil, Entocort EC, Acetylcysteine, Mucomyst, Beclomethasone

COPD Discovery Might Improve Treatment

Posted 15 May 2016 by Drugs.com

SUNDAY, May 15 2016 – Researchers say they've found a new way to predict how chronic obstructive pulmonary disease will progress, a discovery they believe could improve COPD treatment. Their research might help doctors determine which patients are less likely to respond to standard treatment and are at higher risk for disease advancement, the study authors explained. COPD – chronic obstructive pulmonary disease – is a chronic lung disease that makes it tough to breathe. It includes chronic bronchitis and emphysema, according to the American Lung Association. The new discovery concerns something called neutrophilic airway inflammation, which is associated with COPD. Neutrophils are white blood cells that are important for fighting infection. Scientists said that a type of neutrophil behavior called neutrophil extracellular trap (NET) formation in the lungs of COPD patients appears to ... Read more

Related support groups: Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease, Maintenance, Fluticasone, Ribavirin, Qvar, Flovent, Budesonide, Entocort, Tobramycin, Mometasone, Chronic Obstructive Pulmonary Disease, Acute, Entocort EC, Acetylcysteine, Beclomethasone, Mucomyst, Pulmicort Flexhaler, Alvesco, Uceris, Pulmicort Turbuhaler, Asmanex Twisthaler

Arbor Pharmaceuticals Announces FDA Approval of Cetylev

Posted 18 Feb 2016 by Drugs.com

Atlanta, GA, February 9, 2016 – Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Cetylev (acetylcysteine effervescent tablets for oral solution). Cetylev is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. Acetaminophen overdose is the most common poisoning reported to emergency rooms in the United States. According to the American Association of Poison Control Centers there were 73,347 reported acetaminophen exposures in 2014 which resulted in 108 deaths. Cetylev will be available in ready to use effervescent tablets intended to be mixed with water, resulting in a pleasant lemon-mint tasting solution. Currently, ... Read more

Related support groups: Acetaminophen, Acetylcysteine, Acetaminophen Overdose, Cetylev

Popular Antioxidant Seems to Spread Skin Cancer Cells in Mouse Research

Posted 7 Oct 2015 by Drugs.com

WEDNESDAY, Oct. 7, 2015 – A man-made antioxidant appears to accelerate the spread of skin cancer in mice, raising questions about its safety in humans, researchers say. The antioxidant, N-acetylcysteine, is used to relieve mucus production in patients with chronic obstructive pulmonary disease (COPD), said study senior author Martin Bergo, a professor at the University of Gothenburg in Sweden. It also is used as a supplement by people who believe that the antioxidant can help reduce exercise-related muscle damage, burn fat and prevent fatigue, Bergo added. But water laced with N-acetylcysteine appeared to speed up the spread of melanoma, the potentially deadly skin cancer, in lab mice, researchers found. The antioxidant had no effect on the number and size of tumors, but it enhanced the migration and invasion of these tumors to other parts of the body, the research team reported Oct. 7 ... Read more

Related support groups: Basal Cell Carcinoma, Melanoma, Skin Cancer, Melanoma - Metastatic, Acetylcysteine, Mucomyst, Squamous Cell Carcinoma, NAC, Mucomyst-20, History - Skin Cancer, Mucomyst-10, Parvolex, Acetadote, Solgar NAC, Acys-5

That Lingering Cough Could Be Bronchitis

Posted 21 May 2015 by Drugs.com

THURSDAY, May 21, 2015 – If you have a cold that lasts a long time or a persistent cough, you could have bronchitis and should see a doctor, a doctor says. "We see a lot of cases of bronchitis at our immediate care centers," said Dr. Khalilah Babino, an assistant professor of family Medicine at Loyola University Chicago Stritch School of Medicine. Although most cases are caused by the common cold virus or influenza virus, bronchitis can lead to more serious conditions, such as pneumonia, which require medical treatment, she added. Symptoms of bronchitis – a serious disorder of the lower respiratory tract – include fever, chills, chest congestion and productive cough that lasts more than five days, Babino said. "The cough can last two to three weeks and could be an indicator of a more serious condition. If symptoms persist for more than seven to 10 days or symptoms start to get worse, ... Read more

Related support groups: Hydrocodone, Cough, Codeine, Bronchitis, Mucinex, Pneumonia, Guaifenesin, Dry Cough, Dextromethorphan, Robitussin, Benzonatate, Cough and Nasal Congestion, Delsym, Tussin, Tessalon, Acetylcysteine, Tessalon Perles, Mucomyst, Potassium Iodide, NAC

FDA announces voluntary nationwide recall of all non-expired sterile drugs from Unique Pharmaceuticals

Posted 23 Jul 2014 by Drugs.com

July 23, 2014 – The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas. The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products. Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients, as these products may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Unique Pharmaceuticals distributed these products nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502. Two recent inspections of ... Read more

Related support groups: Acetylcysteine, Mucomyst, NAC, Mucomyst-20, Mucomyst-10, Parvolex, Acetadote, Solgar NAC, Acys-5

FDA Medwatch Alert: Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product

Posted 17 Feb 2014 by Drugs.com

ISSUE: Ben Venue Laboratories notified health professionals and their medical care organizations of a nationwide product recall of Acetylcysteine Solution 10%, manufactured for Roxane Laboratories, NDC #0054-3025-02 – Lot 2005479 – Exp. Date March 2014. The recall was initiated on February 14, 2014 after the discovery of a single visible glass particle in a vial within the lot listed above. The nationwide voluntary recall is to the patient level. This recall is limited to lot number 2005479. Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased cl ... Read more

Related support groups: Cystic Fibrosis, Acetylcysteine, Mucomyst, NAC, Mucomyst-20, Mucomyst-10, Parvolex, Acetadote, Solgar NAC, Acys-5

FDA Medwatch Alert: Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

Posted 3 Feb 2012 by Drugs.com

ISSUE: Bedford Laboratories issued an update to the voluntary recall, initiated December 20, 2011 of one lot of Acetylcysteine Solution (Roxane Laboratories) due to the discovery of a single visible glass particle in a vial within the lot. Glass particles can cause airway obstruction resulting in symptoms of choking, wheezing, difficulty breathing, coughing and potentially hemoptysis. Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening. Aerosolization of small glass particles in the airways could result in recurrent infections (due to obstruction of airways, and decreased clearance of airway secretions). BACKGROUND: The single lot is identified as Lot 1877093 – Exp. Date June 2013. Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretion. Acetylcysteine, administered o ... Read more

Related support groups: Acetylcysteine, Mucomyst, Mucomyst-20, Mucomyst-10, Parvolex, Acetadote, Solgar NAC, Acys-5

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Expectoration, Acetaminophen Overdose, Diagnostic Bronchograms

Related Drug Support Groups

Mucomyst, NAC, Parvolex, Mucomyst-10, Mucomyst-20, Acetadote, Cetylev, Acys-5, Solgar NAC

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