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Tuesday
Jun122007

One Door Closes, Another Opens . . .

There are several examples where a drug that’s unsuitable for one use (or indication, as the doctors call it) turns out to be useful in another. The first one to come to mind is thalidomide. It was originally marketed in Europe as a sleep aid, or hypnotic. However, a serious unexpected adverse effect was reported – women taking the drug during the first three months of their pregnancy gave birth to infants with severe malformations: missing or shortened upper limbs, fused legs, and so on. The drug was never introduced in the USA. Some say this was due to the alertness of an FDA reviewer, but the rumor was that she was on vacation for a time and her review was delayed. Anyhow, thalidomide has been revived. It was approved by the FDA in 1998 for treating disfiguring complications of leprosy, and in 2006 for treating multiple myeloma.

Now there’s a new example of ‘. . . another door opens’. Avandia® (rosiglitazone), the oral anti-diabetic drug, has come under attack because of a 43% increased risk of heart attack in people taking it long-term. Its use in diabetes will be severely curtailed, or even withdrawn, if the critics have their way. Just at this time, however, there’s news of effectiveness in a double-blind, placebo-controlled study of patients with ulcerative colitis. This was reported at the Digestive Disease Week meeting by researchers from the University of Pennsylvania . Roughly half the patients on rosiglitazone had a clinical response, compared with only one in 4 on placebo; clinical remissions were also increased with the drug.

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