FDA Warns Three Firms To Stop Mass Producing Unapproved Inhalation Drugs

August 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.