FDA Warns Three Firms To Stop Mass Producing Unapproved Inhalation Drugs
Posted: 08/12/2006
Thursday, August 10, 2006
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The FDA notified consumers and healthcare professionals that RoTech
Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, are
manufacturing, and distributing nationwide, unapproved compounded inhalation
drugs. These drugs, compounded by pharmacists, are used to treat
life-threatening conditions such as asthma, emphysema, bronchitis, and
cystic fibrosis. Compounded inhalation drugs are not reviewed by the FDA
for safety and effectiveness and are often not produced according to good
drug manufacturing practice, which may expose patients to unnecessary risks.
FDA urges consumers using inhalation drugs to discuss their medications with
their physicians and verify with their pharmacists that the medications they
received are what their physicians ordered. FDA encourages patients to use
FDA-approved drugs whenever possible.
Read the complete MedWatch 2006 Safety summary, including links to the FDA
Press Release by visiting the link below.
Link to Original Press Release:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Inhalation
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