Improper Information on Drug Labels

A medicine can save your life but at the same time it can also take your life if not taken as prescribed. In United Sates before a drug is introduced in the market, it is tested in three levels of clinical trials. This is done to ensure that the new drug treats certain medical condition in the way it is supposed to consume and is safe when used as directed.

When the Food and Drug Administration (FDA) is satisfied with the drug, the drug manufacturers prepare a drug label reporting the specific information. The report is approved by FDA and is made available to doctors who will prescribe the drugs. Now let’s get an idea about the importance of drug warning labels and off-labels.

Consumer’s duty before taking prescribed medicines

Before taking any medicine you should be well aware of the side effects. So you must read the warning labels. It is better to have a detail discussion with your doctor about the pros and cons of the medicine he has prescribed. You should also know whether it s an FDA approved drug or an off-label use. If it is FDA approved, you are assured of safety but if it is an off-label use, there remains a little doubt about some unknown risk.

Off-Label Drug Use

When a drug is used in a different way than described in the FDA drug label, it is said to be an off-label use. This means that the drug is used for a different disease, given in a different way and in a different dose other than the approved drug label. For example when a chemotherapy drug is approved for treating one type of cancer, but is used to treat another type of cancer, it is off-label use. Though this type of drug is not regulated but it is legal in United States.

But sometimes to make a fortune in sales, the manufactures start a big promotional push to foist some drugs on the public. For example Topamax, named Neurontin, a migraine medicine was once sold widely as a mood stabilizer, pain reliever and weight loss drug. Its manufacturers named it as an off-label use but due to its bad side effects, it has been sued by the Government.

Duty of Drug Manufacturers 

The utmost duty of the drug manufacturer is to reveal all the risks and benefits of consuming a specific drug. It should detail all the information in the warning label approved by FDA to give a clear idea about the medicine to the consumers. But sometimes the drug companies make some misleading advertisements to overstate the benefits of a particular medicine, which is wrong. The warning label should only contain the ingredients, dosage and the harmful side effects on consumption. If any harm is caused after consuming a prescribed drug, where the risk of side effect has not been clearly mentioned, you may sue the drug manufacturer. The drug developer will be held liable for that.

Additional Labeling by the State

FDA approves a nation wide warning label. But sometimes for better safety of its people, the state law may demand to provide additional information. But problems may occur when the FDA warning label becomes inconsistent with that of the state. But if the alterations in the label ensure more safety to people, this modification can be allowed.

So, before taking medicines read the warning labels carefully and don’t ever hesitate to consult your doctor. You should be well aware of the various side effects that may cause you harm after consuming a particular drug. Whether it is a fault on the part of the doctor or the drug manufacturer, you will be the ultimate sufferer by consuming a wrong medicine. If the fault is not on your part you are always free to take any legal action against the wrong doer.