another resource and excellent discussion from Foolish Premise on hypersensitivity. The price has been declining precipitously to less than $21 now and Dow Jones issued a headline saying something like -- Some doctors are still using Cypher despite being idiots --. Geez. I can't keep up with all the Yahoo posts and that is always the trouble when a stock's price moves significantly over there. The best SI boards of which I'm aware, suggest that posters never discuss price or each other. Finally! The Post:
Hypersensitivity
by: foolishpremise (38/M/Vancouver, BC) 10/30/03 02:34 am
Msg: 6356 of 6441
"FDA has also received more than 50 reports, including some deaths, that Cordis considers to be possible hypersensitivity reactions. The symptoms include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes."
A sampling of these MAUDE reports can be found at the link I have provided.
accessdata.fda.gov ch=1&SearchString=cypher%20AND%20allergic&SearchYear=A&ProductCode=&KNumber=K&PM ANumber=P&Manufacturer=&BrandName=&EventType=&ReportDateFrom=&ReportDateTo=&PAGE NUM=10&Key_Count=30
The bulk of these are for a rash which often has resolved, or is resolving at the time the report is submitted.
It is often noted that the rash appears to begin resolving when another drug (notably plavix or ticlid) is discontinued. These drugs are probably more often the culprit.
Two reports talked of allergic signs or symptoms beginning late, at 35 days and at 2 weeks, and didn't say how the patient's condition progressed. I would have wanted to know more about these, as they are more likely to cast suspicion on the polymer than the other reports, but no other information is available. They are, however, only two reports.
I could only find one death (not in the sample I have included), and it is difficult to say it was a hypersensitivity reaction - it is just as likely to be sepsis (overwhelming bacterial infection).
Overall, I am happy with what I have read, as I don't see a worrisome pattern here.
I'm actually surprised at the FDA sending out the letter they did. Sure they are getting lots of reports of adverse reactions - but it's a new device with a huge marketshare for which they recently urged adverse event reporting (their first letter). |
