Understanding the FDA's Action Regarding Digoxin
The FDA's press release on action surrounding Digoxin

It is rare that the FDA or drug manufacturers issue recalls. The onset of a recall usually only occurs in a situation of dire emergency.

The reasons why a drug may be recalled vary. Usually, when a drug is recalled it is because the drug has proven unsafe for consumers. In a summation, the reason the FDA acknowledged the recall of Digoxin and its variants was because a sample of its tablets were produced with double the recommended dosage of medicine. Needless to say, this created a huge risk for adverse effects and after a number of patients logged their adverse reactions with their physicians the FDA took action and issued the recall. The recall press release itself – for lack of a better word – is somewhat wordy. So, a brief summation of the main points of the FDA's action will be provided herein.

The Drugs Involved: Digoxin tablets are known by two common brand names: Bertek and Digitek. The company UDL Laboratories produces Digitek while Actavis Totowa/Amide Pharmaceuticals, Inc produces Bertek.

What They Are Used For: These drugs are designed to treat instances of abnormal heart rhythms as well as outright heart failure. If a patient ingests double the recommended dose via the faulty tablets then the patient is at risk for digitalis toxicity. As the name would imply, digitalis toxicity is the poisoning of the system from taking excess amounts of the prescribed drug. Since the flaw with the drug is that a single tablet actually contains a DOUBLE dose then taking the recommended dosage of a flawed tablet could lead to an overdose.

Digitalis Toxicity Defined: This is essentially a poisoning of the system which results in the patient suffering various adverse effects including nausea, vomiting, dizziness and even possible cardiac arrest. While there have been no reported fatalities, the potential for death does occur in such when one suffers from this condition. The onset of this is most common with those who are dealing with renal failure.

Patient Information: Anyone who has been taking the drug has medical questions is recommended to call their physician or health care provider. Calling the manufacturer or the pharmacy with questions related to one's medical condition would be of little use and is not recommended.

Customer Service Inquiries: The FDA suggests that any customer service inquiries regarding this product should be directed to the customer support wing of Stericycle at 1-888-276-6166. Also, further information on the subject of this (voluntary) recall can be found at the manufacturer's website www.actavis.us. It is critical to direct customer service inquiries to the correct recipient or else you would be wasting valuable time. Calling a pharmacy, for example, may be of little use.

Retailer Information: Retailers who have inventory of the drug are recommended to return the drugs where they were purchased. This would be the best way to expedite the recall action as involving third parties could prove laborious. This is an important point to note as any excess time spent communicating with someone who is unable to help will do little other than slow down the recall process.

Adverse Reactions Report: Any patient who has suffered adverse reactions from the drug is suggested to call the FDA's MedWatch Program at 1-800-FDA-1088. This is a very important point because it allows the FDA to compile critical information on adverse symptoms associated with the product. From this, a clearer understanding of the harm the drug is causing can be notated. From this, appropriate responses to the problem can be devised as well.