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Side Effects: Can I Report Drug Side Effects to the FDA?

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Updated December 04, 2008

Question: Side Effects: Can I Report Drug Side Effects to the FDA?

A question from a friend, who I ran into at my local supermarket: I have had some serious adverse reactions to Fosamax. How do I contact the FDA to address my issues with Fosamax? I really think they should know.

Answer:

I’m sorry to hear that you have had problems with Fosamax (alendronate). I have had many questions from readers about osteoporosis medications, especially the bisphosphonates, the class of medications that includes Fosamax.

The U.S. Food and Drug Administration (FDA) has an online service called MedWatch, which provides online access to safety alerts published by the FDA since 1996.

In addition, consumers and healthcare professionals can submit a report to MedWatch concerning serious drug reactions, medication quality problems, therapeutic failure (the medication failed to work or did not work as expected), and errors in the proper use of the drug.

To submit a complaint, go to MedWatch Reporting by Consumers. Click on the online reporting link and follow the instructions. You can also download and print a form to mail in.

I hope this information helps.

More Information About Osteoporosis from Dr. Mike:

  1. About.com
  2. Health
  3. Drugs
  4. Medication ABCs
  5. FAQs About Your Drugs
  6. Reporting Side Effects to the FDA - How to Report Serious Side Effects to the FDA

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