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Copyright © 2013 Natural Standard (www.naturalstandard.com)
February 2012

Company Updates Recall on Acetylcysteine Solutions

Bedford LaboratoriesTM has updated its guidelines regarding previously recalled acetylcysteine solutions. The recall first began on December 20, 2011 after a piece of glass was found in a vial of acetylcysteine manufactured for Roxane Laboratories, Inc.

Acetylcysteine, also called N-acetyl cysteine (NAC), is a derivative of the amino acid L-cysteine. The molecule is a source of sulfhydryl (-SH) groups, which allow it to act as a potent antioxidant.

NAC has traditionally been used as a decongestant due to its ability to break mucous disulfide bonds and decrease mucous viscosity (thickness). It has also traditionally been used to reduce poisoning associated with various compounds, such as acetaminophen, the generic name for a common nonprescription medication useful in the treatment of mild pain or fever, and heavy metals.

A major concern for patients presenting with acetaminophen poisoning is the possibility of liver damage or failure. Early standards of care for acetaminophen overdose included emesis, lavage and supportive care. However, using only supportive care resulted in 5-10% death rate and a high incidence of liver damage. This damage was caused by the fact that the breakdown of acetaminophen in the body causes an increased demand for glutathione, a short chain of amino acids that is necessary for certain reactions in the body. NAC supports glutathione synthesis, especially when the need for glutathione increases. Therefore, NAC has been used for over 25 years as an antidote to acetaminophen overdose.

In addition, NAC is also commonly used to treat lung infections and encourage the clearance of sputum (mucus from the lower airways). NAC has been used in the treatment of chronic bronchitis since the 1960s. It was originally studied as an inhalation treatment, but more recently, it has been used as an oral agent.

NAC is generally well tolerated. The most frequent complaints involve diarrhea, nausea, and vomiting. NAC is also well known for its unpleasant taste. Several methods have been used to try to mask the taste. Severe headache is reported when NAC is used in combination with nitroglycerin.

Starting on December 20, 2011, 30 milliliter vials of 20 percent acetylcysteine solution (manufactured for Roxane Laboratories, Inc.) with the lot number 1877093 and an expiration date of June 2013 were recalled from clinics, emergency rooms, hospitals and physician offices. Now, the recall is being extended to the patient population. Individuals who received these solutions from a medical care provider are being advised to return the item to their pharmacist. In addition, any retailers or distributors of this drug should contact GENCO Pharmaceutical Services at 6101 North 64th Street, Milwaukee, WI 53218 if they have not been given a recall packet. Any questions or concerns about this recall can be directed to GENCO Pharmaceutical Services at 1.800.950.5479.

Despite the possibility of potentially contaminated vials of acetylcysteine being introduced into the market, this treatment has generally shown strong or good scientific evidence for treating for preventing liver damage associated with acetaminophen poisoning, as well as increasing the clearance of mucus associated with chronic bronchitis and respiratory infections. However, patients may also elect to use other integrative therapies to treat or prevent both of these conditions. Listed below are examples of integrative therapies that have shown strong or good scientific evidence for preventing or treating liver damage, as well as preventing or treating respiratory disorders.

Andrographis paniculata Nees, Kan Jang®, SHA-10: strong scientific evidence for treating upper respiratory tract infections

Betaine anhydrous: good scientific evidence for treating non-alcoholic steatohepatitis

Black seed: good scientific evidence for treating respiratory disorders

Borage seed oil: good scientific evidence for treating acute respiratory distress syndrome

Caffeine: strong scientific evidence for treating respiratory disorders

Cordyceps: good scientific evidence for treating cirrhosis or chronic hepatitis B

Echinacea: good scientific evidence for treating or preventing upper respiratory tract infections in children and adults

Elderberry or elder flower: good scientific evidence for treating influenza

Milk thistle: good scientific evidence for treating cirrhosis of chronic liver disease

Molybdenum: good scientific evidence for treating the symptoms of Wilson's disease

Probiotics: good scientific evidence for treating cirrhosis

Umckaloabo: strong scientific evidence for treating bronchitis and good scientific evidence for treating acute pharyngitis or the common cold

Vitamin C: good scientific evidence for preventing the common cold in extreme environments

Zinc: good scientific evidence for treating Wilson's disease

For more information about N-acetyl cysteine, please visit Natural Standard's Foods, Herbs & Supplements Database.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. U.S. Food and Drug Administration (FDA). www.fda.gov
The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited.