Application No
The following adverse reactions have been identified during post-approval use of amiodarone hydrochloride tablets
Of the products listed in
Common amiodarone side effects may include: nausea, vomiting, loss of appetite; or
The larger issue with amiodarone is drug companies that have been peddling the drug for many years for off label uses not approved by the FDA
Food and Drug Administration approved Even authorities refer to it as a “drug of last resort,” even though the FDA has conditionally approved it
oHCM is a rare disease that occurs when the heart muscle thickens, mostly in the septum (the heart wall that separates its right and left sides) and obstructs blood flow from the heart to the rest Drug Review Package
Nexterone (amiodarone hydrochloride), 50 mg/ml InjectionCompany: Prism Pharmaceuticals, Inc
After you have taken this medicine for a long time, it may cause a blue-gray color to appear on your skin, especially in areas exposed to the sun, such as your face, neck, and arms
In 1985, Wyeth Pharmaceuticals (once known as Wyeth-Ayerst Laboratories) received FDA approval to sell amiodarone hydrochloride under the brand name
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That is precisely what occurred with Amiodarone when the FDA granted Wyeth Pharmaceuticals approval to market and sell This information has been updated in the December 15, 2011, FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone
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Report a Serious Problem MedWatch Online Regular Mail: Use postage-paid FDA Form 3500 Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20857 Amiodarone belongs to the group of medicines known as antiarrhythmics
Before Using
However, this drug is also widely used off-label to treat supraventricular tachyarrhythmias, such as atrial fibrillation, and to January 07, 2009
: 75-188 Approval Date: 2/24/1999
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