When Drug Side Effects Get Out Of Hand

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions and problems with medical products, such as drugs and medical devices. If you or someone in your family has experienced a serious reaction to a drug or medical product, you are encouraged to take the reporting form (PDF format) to your doctor. Your health care provider can provide clinical information based on your medical record that can help us evaluate your report. To get a hard copy, call MedWatch at 1-800-332-1088, and one will be sent by mail or fax. You can also submit the form by fax to MedWatch's fax number, 1-800-332-0178.

However, for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself via the internet.

You will receive an acknowledgement from FDA after they receive your report. You will be personally contacted only if they need additional information.

If you would prefer to report your adverse experience by telephone, or if you have a complaint about a medical product, please call:

FDA Office of Emergency Operations: 301-443-1240

If you have additional questions about the medical product which caused your problem, or if you need additional hard-copy MedWatch reporting forms, call:

FDA Toll Free: 888-463-6332 [888-INFO-FDA]

What About Thyroid Drug Reactions

Most physicians will tell you that thyroid hormone replacement drugs like levothyroxine are safe. But even these so-called safe drugs have a host of known symptoms, and many othe rpatients may have adverse effects that, because they aren't reported, go unknown by the majority of doctors and patients. Taking too much levothyroxine can cause a variety of symptoms of overdose, including:

• chest pain
• nervousness, anxiety
• insomnia, trouble sleeping
• tremor
• rapid heartbeat
• nausea
• headache
• fever
• sweating
• shortness of breath
• heat intolerance
• irregular menstrual period
• increased appetite
• weight loss
• diarrhea
• abdominal pain

Other side effects some people can experience from levothyroxine include:

• an allergic reaction (such as difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives). If you have such a reaction, go to an emergency room right away, or call 911.
• vomiting
• chest pain
• irregular heartbeat
• shortness of breath.
• tremor, nervousness, or irritability;
• headache;
• insomnia;
• diarrhea, changes in appetite, or weight loss;
• leg cramps;
• menstrual irregularities
• fever, sweating, or heat sensitivity.

And patients have reported NUMEROUS other supposed side effects from thyroid medications.

If you have adverse reactions to your thyroid drugs, or to any drugs, it's important to encourage your physicians to file a report. But if your doctor won't file a report -- which is likely, as many of them have quite cozy relationships with the manufacturers of the their favorite drugs -- then it is up to you to file a report, and make your concerns known. Only this way will some of the lesser-known symptoms of drugs -- including the so-called "safe" thyroid drugs -- become known.