a bit of history on my use of entocort

[grannyh]

When I first heard about entocort it had been approved and then withdrawn from the market in the US. When I finally found a great doctor with other patients with CC he told me about it as well. When it became available again he said I would have to have blood tests done and sent to Prometheus Labs in Calif. They had approval rights (not sure of the legal term) for who could take entocort at that time. The reason it was withdrawn is because doctors had used entocort for D and constipation..causing deaths in the constipated patients..even though doctors had been told repeatedly NOT to use it for patients with a combination of D and constipation and constipation alone. It was misuse of the drug by doctors (thus causing deaths) that caused the drug to be withdrawn from the US market.

My first prescriptions did say Prometheus Labs on them as do the current prescriptions. I am assuming their control over the market of entocort by requiring tests first was to prevent the drug from being wrongly prescribed by doctors. I do not know if there are still such controls (testing first) in place in the US.
grannyh

[tex]

That's some interesting information. I wasn't aware of that. Somewhere along in there, Prometheus Labs bought full rights to the product from AstraZeneca, but I don't know exactly when that took place. As far as I am aware, though, no prior approval is required, these days.

Doctors misusing, (wrongly prescribing), drugs? Say it isn't so.

Maybe that earlier problem is part of the reason why so many doctors are still reluctant to prescribe Entocort.

Thanks for the insight.

Tex

[Rosie]

I'm wondering if this was Lotronex, not Entocort. The confusion may have resulted because both are sold exclusively by Prometheus. Here is what I read about Lotronex (alosetron)

Serious or fatal side effects on the stomach and intestines have occurred in some people taking alosetron. In rare cases, alosetron has caused severe constipation, or ischemic colitis (caused by reduced blood flow to the intestines).

And from the Proetheus site:

In January 2008, we acquired exclusive rights to Lotronex in the United States from GlaxoSmithKline. Lotronex is the only prescription drug approved by the FDA for use in female patients with severe diarrhea-predominant irritable bowel syndrome, or IBS, who have chronic IBS symptoms, have had abnormalities of the gastrointestinal tract excluded and have not responded to conventional therapy. Prior to our acquisition of Lotronex, GlaxoSmithKline voluntarily withdrew Lotronex from the market in 2000. The FDA approved a supplemental New Drug Application for Lotronex in 2002 with a more limited indication and it was subsequently re-introduced to the market. In order to reduce the potential for harmful side effects of Lotronex, the drug is subject to a special prescribing program designed to ensure that only doctors who have enrolled in the Prescribing Program for Lotronex™ write prescriptions for the drug. In connection with their enrollment into the prescribing program, the physicians must have an understanding of IBS and be familiar with the side effects and risks of Lotronex.

Rosie

[tex]

Tex

[grannyh]

You may, indeed, have discovered the rest of the background on entocort. My gastro doc was not happy when the drug was withdrawn from the market. But I started on Entocort in the fall of 2005.. after the hurricane Katrina evacuation during which I was able to eat almost nothing that did not cause problems. When I got back to Texas I made an appt with gastro doc and said I was ready for entocort:) That is before the purchase of the rights for lotronex. However, they may have had rights for producing it (or dstributing it) before they bought the company.

I had tried asacol but it made me extremely ill. I was not able to just go in and say... I want entocort..as I said earlier I had to go through the Prometheus testing to be allowed to take it.
grannyh