November 2000 Recalls

November has been an average month for recalls. As you read the list of the products that were recalled, for clarification as to the class of recall, check my link on the front page of the Public Health Issues site.

Lotronex is a medication that has been in the news lately, being heavily covered due to the discoveries of the hazards of women taking this drug. I myself covered this story in August of this year, outlining the potentially fatal side effects that could occur. Unfortunately the outcry of many was not heeded in time. Lotronex was recalled by Glaxo Wellcome after five deaths were reported from use of this drug. Keep in mind that this medication is not a drug for a life threatening illness but is for irritable bowel syndrome. I would never imply the IBS is not a miserable condition to live with, but living with it is preferable to what happened to the five women who died. There were also reports of severe and adverse side effects and physicians have been advised to seek other treatment for women on this medication.

The information that I was able to uncover seemed to indicate that the FDA was concerned that the medication was causing ischemic changes in the bowel (lack of adequate blood supply to enable to organ to function properly) thus causing organ damage. The FDA also claims that they were closely following this drug since its approval in February of 2000. What seems to be overlooked entirely is that the FDA had warned about this drug and the potential deadly side effects, ordering Glaxo Wellcome to put in plain English the risks in print for the patient. In my plain and simple English: The FDA and Glaxo Wellcome were both aware of the problems with Lotronex yet did not recall it until five women died. Apparently on June 27, they did direct the physicians and pharmacists to inform patients of the potential dangers, but since there is no law requiring pharmacists to divulge this information, as discussed last week, it seems an empty directive.

There is no official class on this recall but I think it is safe to say that it would be considered a Class I. For official information on this recall, the FDA has an information sheet on their website.

Other recalls this month are less serious and due to space restrictions, I will list them by name. For further information, contact your pharmacist if you use these products.

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