"BAD CORTEF BATCHES"
5/5/99 10:30 PM
Hi everyone, I have been e-mailing a few of you and reading this great board. The Cortef issue hits very close to home for me because I am not only the mom of a 6month old CAH son, but I am a pharmacist. When we brought our son home after his diagnosis and first hospital stay, we took the Cortef suspension bottle home with us. When we got the prescription filled the pharmacy gave us 2 bottles(MD ordered 8 ounces) of the drug and it was in its original container. Being as anal as I am, I looked the bottles over and noticed "white" powder stuck on the bottom(inside) of the bottle. I shook each one vigorously for a very long period to try and "suspend" this powder. It worked. The next time we got a refill, a different pharmacist dispensed the med and put it in a brown prescription bottle(he had poured it out of the original container). The 3rd time it was original and now it is currently in a brown bottle. I don't know if my son had a real growth spurt or if there were med problems but his last 17-OHP was 2479(4 months old taking 1.6ml every 8 hours) during the "brown bottle" time.The Endo adjusted his dose to 2ml every 8 hours. Since reading all the letters on this board I really began to worry about the Cortef. I knew when I had original containers that it was shaken well, but when the pharmacist dispensed it had he taken the time to shake it like I would--not as likely. Everyone knows how busy their local pharmacist is!! My thoughts are that there may be a problem with the drug settling out in the bottle, so I called Pharmacia & Upjohn today(phone 1-800-253-8600) and spoke to drug info specialist Ron Schrock about my concerns. I work in a hospital pharmacy so we have more access to certain drugs than a retail pharmacy might and I pulled all our Cortef suspension to see if there was white powder on the bottom inside the bottle.Sure enough, all 4 bottles had settled out. I told Mr. Schrock about all of our stock bottles and he told me about the re-formulation issue and that they are now using a different suspending agent. I asked if there was any way he could check into this. He told me to send one of our stock bottles back to them for analysis and they would try to determine if the white powder was drug. I'm sure this wouldn't be difficult for them to determine as soon as the quality assurance folks took a look at it. He told me it would take about a week or two to hear results.He also asked me to write a letter explaining what happened and tell them about all you guys with kids who have 17-OHP levels in high range while on the Cortef. I am asking anyone who has concerns about Cortef to call the manufacturer or write them at this address: Global Regulatory Affairs Technical Services Pharmacia & Upjohn Attention: Susan Perry 7000 Portage Road Kalamazoo, Michigan 49001 MY POINT: Could you all be getting Cortef that has settled to the bottom of the container and it has not been shaken well by you or the pharmacist , or are the batches themselves still bad. It takes more than one person to be heard on these issues with drug companies. Call or write anyone you know that had this Cortef problem and encourage them to get in touch with the drug company. OUR KIDS LIVES ARE DEPENDING ON IT! Anyone with questions please e-mail me. Thanks, Michele Harrington
Michele
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