Questions and Answers for Withdrawal of Duract

1. I am taking Duract now. What should I do?

• If you are generally in good health, if you are taking Duract for the first time, and if your prescription is for 10 days or less, contact your health care professional about whether you should finish your prescription or change to another pain reliever.

• If any of the following apply to you, you should stop taking Duract, and ask your doctor about substituting another pain reliever.

  -You have been taking Duract for more than 10 days ...

  -Your know you have a liver problem or liver disease ...

  -You have used Duract before ...

2. Are there any problems if I suddenly stop taking Duract?

No. The only problem is that your pain may come back. If you have any other questions, you should contact your health care professional.

3. I have taken Duract but am not taking it now. Should I be concerned?

No. Serious liver problems have only occurred while taking Duract or within several days after stopping. If you have any other questions, you should contact your health care professional.

4. I have taken Duract but am not taking it now. What should I do?

If you are feeling fine, there is nothing special you need to do because we have not seen any delayed problems. If you have any other questions, you should contact your health care professional.

5. How do I know if I am having liver problems from Duract?

Any liver problems would start to appear while taking Duract or within several days of stopping. If you are experiencing any of the following, contact your health care professional immediately.

• Unusually dark urine
• Yellowing of the whites of the eyes
• Pain just below your ribs on the right side
• Nausea and vomiting
• Loss of appetite
• Yellowing of your skin

6. What is the risk of Duract causing serious liver problems?

If Duract is taken for longer than 10 days, typically for a month or more, there is increased risk, but the risk is still felt to be small. Based on the current data, one case of severe liver injury has been reported so far for every 10,000-20,000 people who have taken the drug for longer periods of time.

7. What should I do with any leftover Duract I still have from an old prescription that I did not use up?

Do not take the left over Duract. Throw it away. If you have any question about refunds call the company, Wyeth-Ayerst, at 1-800-281-9260.

8. What about Duract with alcohol use?

We do not have any specific information about using Duract with alcohol. However, we would recommend avoiding alcohol while taking it as well as for several days after stopping Duract.

9. Why was Duract approved? Why wasn’t this problem picked up during the trials of the drug prior to approval?

While there are many pain relievers, there is still a need for good medicines. Duract was effective in relieving pain. The safety profile of Duract was acceptable in testing before approval. No cases of serious liver injury were reported in pre-marketing clinical trials. There were some cases of liver enzyme elevations in patients treated for 30 days or longer, but these elevations resolved with discontinuation of therapy and patients did not experience any problems. Therefore, Duract was approved with labeling that described this potential for elevated liver enzymes and limited product use to 10 days or less for management of acute pain.

10. What has been done regarding Duract safety?

The FDA and Wyeth-Ayerst have been closely watching the safety of this drug, as we do for all drug products. We found a rare but serious liver problem as more people took Duract for extended periods of time beyond that recommended in the labeling. As a result, on February 6, 1998, a "Dear Health Care Professional" letter was issued to tell health care professionals about this new toxicity. At that same time, labeling changes were made to reinforce safe use of Duract, and safety monitoring was increased.

11. Why is Duract being withdrawn now?

Subsequent to the "Dear Health Care Professional" letter, additional and more severe cases of liver damage continue to be reported. At this time, we have received reports of 4 deaths, 8 patients who survived but required a liver transplant, and 12 other patients with serious but less severe liver damage. Almost all of these cases occurred among an estimated 200,000-400,000 patients who took Duract for longer periods of time. Duract is effective and the risks are acceptable when used as labeled. However, further efforts to limit the use of the product to 10 days or less would not be practical or effective, and could not guarantee that patients would only get 10 days or less of Duract. Based on this new information about the risks of Duract and the availability of other therapies with a wider margin of safety than Duract under long-term use, the decision was made that the product should be withdrawn.

12. How do the FDA and companies find out about such rare and serious problems?

We cannot know everything about the safety of a new product when it is first marketed.

Rare side effects cannot be detected in most drug development programs. This is why we have the Spontaneous Reporting System to identify rare events, allowing constant reassessment of the overall risk to benefit relationship of the product. Discovering rare toxicities after marketing and acting upon the new information shows the Spontaneous Reporting System is working well.

We rely heavily on observant Health Care Professionals and their patients to report serious drug side effects and product problems to FDA/MedWatch and the company. Doctors, pharmacists, nurses, and other health care professionals can report to MedWatch by:

• Telephone at 1-800-FDA-1088.
• Fax at 1-800-FDA-0178.
• Mail postage paid MedWatch form.

For more information, visit the MedWatch website at www.fda.gov/MedWatch.

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