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Amber Racine
Amber Racine
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What to Do When the FDA Changes the Warning on Your Medicine

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Anyone who watches the evening news has heard about the FDA changing or updating the warning label on a medication. For those people who are taking that medication, this is startling and frightening news, and there are steps that should be taken to protect your health and your legal rights.

First, you should schedule a visit with the doctor that prescribed the medication. This is an important first step, because your doctor should reassess your need for the medication based on the new warning label. It is also vital to speak with your doctor before you stop consuming the medication, because you should not stop taking any medication without the advice of a medical profession. You can ask your doctor about the new warning label and the risks associated with the medication. It may help to make a list of your questions and concerns before going to the doctor, so that you can make the most of the appointment.

Second, you should read the updated label for the medication. You may have the medication and its warnings information in your home, but they won’t contain the updated information. It is best to view the new label/product information on the internet by visiting the FDA’s drug information website at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. By reading the label you will learn information that you should address with your physician, as well as the symptoms to watch out for. For example, when the Fosamax label was changed by the FDA last year the new label warned patients and physicians to be aware of new hip, groin or thigh pain. The FDA’s website will also offer key information on the reasons for the new warning and may link you to informative studies. By reading the label on the FDA’s website you can also sign up for updates on all of the medications you take.

Third, if you have experienced any of the adverse symptoms or side effects that the updated warning label addresses, you may want to take some time to research your legal rights. For most people, this won’t be the foremost thing on your mind, but because the law has deadlines for you to bring a claim, known in legalese as a “statute of limitations”, delaying for too long a period may rob you of your rights.