Newswise — Recently, Food and Drug Administration (FDA) officials sent warning letters to Lincare, Rotech and CCS Medical, three national homecare pharmacy businesses, to stop mass manufacturing unapproved nebulizer medications. Used primarily by patients with asthma, emphysema, chronic bronchitis and cystic fibrosis, the unapproved medications were mixed in facilities not licensed or inspected by FDA and then substituted in place of commercially available brand and generic vials approved by FDA for safety, efficacy and sterility.
Rotech, the first company to respond to FDA's warning, said they would stop manufacturing the vials immediately. Rotech projected the change would cause a loss of more than $30 million in revenue for the year and affect more than 30,000 patients. Lincare and CCS Medical did not disclose the number of patients affected, but FDA says millions of doses of unlawful medications have been manufactured and distributed.
Allergy & Asthma Network Mothers of Asthmatics (AANMA), a national nonprofit organization based in Fairfax, VA, surveyed 483 members of the American College of Allergy, Asthma and Immunology (ACAAI) to determine how many recommend unapproved nebulizer medications for their patients. Results of the survey were presented November 12 at ACAAI's Allergy, Asthma and Immunology Annual Scientific Meeting.
Ninety-eight percent of allergists said it is "important" or "critically important" that the nebulizer medications they prescribe are FDA-approved for safety, efficacy and sterility. Less than one percent said they were likely to prescribe nebulizer medications made in a facility that was not registered or authorized by FDA. Ninety-nine percent said it is "important" or "critically important" to be able to trust the pharmacist to dispense the medication the allergist intended the patient to receive.
According to case reports made by patients who received unapproved nebulizer medications from these companies, neither patients nor their physicians were aware that their nebulizer medications were not FDA-approved or the there were possible associated health risks of using them. When they stopped using the unapproved medications, several patients stated that their symptoms improved.
AANMA calls on FDA and State Pharmacy Boards to protect patients from serious health risks associated with the use of unapproved nebulizer medications. It's time to shut down companies that unlawfully mass manufacture and dispense nebulizer medications to patients in place of FDA-approved medications prescribed by their physicians.
About AANMAAllergy & Asthma Network Mothers of Asthmatics is the leading nonprofit organization dedicated to eliminating suffering and death due to asthma, allergies and related conditions. AANMA's core areas of expertise are education, advocacy and community outreach. AANMA's flagship publications " "Allergy & Asthma Today" magazine and "The MA Report" newsletter " and its Breatherville.org Web site are consumer lifelines to medical news and healthy living.
AANMA convened the Consumer Health Alliance for Safe Medication (CHASM), a working group of 12 patient and professional healthcare associations, to ensure patients with respiratory conditions have access to safe and effective medications and are protected from products that may pose unwarranted risks. These respiratory conditions include asthma, cystic fibrosis, pneumonia and chronic obstructive pulmonary diseases (COPD).
Read more about unapproved nebulizer medications in "Are there Fakes and Frauds in Your Nebulizer?" at http://www.aanma.org/pdf/pu_fakes_frauds.pdf and get the latest updates on this issue at http://www.breatherville.org/CHASM.
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