View All General Comment Abuse Story Death Story Chronic Pain Story       Please sign our Guestbook Name:Thank God Email: Type:Administrator Date:7/14/2005 Government orders halt to painkiller sales LAURAN NEERGAARD Associated Press WASHINGTON - The Food and Drug Administration ordered a halt to sale of the narcotic Palladone on Wednesday, citing potentially fatal reactions when the potent drug is taken together with alcohol. The FDA approved Palladone just last September. It is a once-a-day version of the old painkiller hydromorphone, made in a way that allows the capsules to dissolve slowly over a 24-hour period. But data from a new study by the drug's manufacturer shows that taking Palladone together with alcohol can harm the capsule's slow-release function, rapidly dumping the narcotic into the bloodstream and potentially causing a fatal overdose, the FDA said. Maker Purdue Pharma agreed to suspend U.S. sales of Palladone pending further discussions with the FDA about the risk, the agency said. Like many narcotics, Palladone's label already warns against alcohol consumption while using the painkiller. "But the current formulation of Palladone presents an unacceptably high level of patient risk," said FDA drug chief Dr. Steven Galson. "Even one drink could have fatal implications." The FDA said it has no reports of serious reactions among users yet, but the drug is too new to have been prescribed very often. About 11,500 patients have taken Palladone, said Purdue Pharma spokesman Jim Heins. The company asked drugstores and wholesalers to return unsold capsules. Patients aren't being told to stop taking current supplies, but in a public health alert issued Wednesday, FDA urged them to consult a physician for alternative treatments. Anyone continuing to use up their Palladone supply should not drink any alcohol - or take other prescription or over-the-counter medicines that contain alcohol. FDA's reaction was unusually quick, coming just five months after sales of Palladone began and before the problem had come to public attention. But it comes at a time when federal regulators are being urged to more aggressively ensure the safety of drugs already on the market, pressure that has increased since Merck & Co. yanked its pain reliever Vioxx from the market last year because of potentially deadly heart trouble. Purdue Pharma also makes the controversial long-acting painkiller Oxycontin, and it had waged a long battle to market Palladone because of concern that long-acting hydromorphone, too, might be abused. Consequently, the company had limited initial Palladone sales to doctors experienced in prescribing opioid painkillers. The drug is for moderate to severe pain, caused by cancer or other conditions, in patients who need round-the-clock relief. Oxycontin tablets are made in an entirely different way than Palladone capsules, which package together individual controlled-release pellets of hydromorphone. ON THE NET Food and Drug Administration: http://www.fda.gov Purdue Pharma: http://www.pharma.com   Name:Jennifer Email:[email protected] Type:General Comment Date:7/12/2005 I will tell my story here in the future. Right now it still hurts too much. What I would like to know is how we, ordinary people, can change things. I am willing to go the distance and do whatever it takes to try and put an end to the corporate drug dealer's disregard of whose hands oxycontin ends up in. I was told by the police department a few weeks ago that Purdue Pharma could care less who buys it or where as long as they are making a profit. Southwest Virginia... tiny little towns where it should be safe to grow up, get married, raise a family have become afflicted with the scourge of Oxicontin. In these rural communities, Oxycontin is big business (millions of dollars). Entire families do nothing but lie, cheat, steal (even from each other) to support their habits. It is time to put a stop to this... but how? I have to do something. I can not stand idly by and watch this happen to other families. It hurts too much and if I can keep one person from getting that phone call saying that their child is gone, I will feel like I have accomplished something. Someone needs to be held accountable. Christopher, my baby, I miss you terribly. Just to hear you laugh again...February 2, 1985 - June 10, 2005   Name:Sandi Casey Email:[email protected] Type:General Comment Date:7/12/2005 My 80 yr old mom got out of her van while it was still running and in reverse and ran over herself. She spent two weeks in the hospital and had a skin graft on her leg which was degloved during the accident. Sometime during the first couple of days in the hospital she had a mild stroke. The stroke has left her unable to communicate with us (aphasia (sp?), however she understands everything that we say to her, she has no problems moving arms and legs (other than becuase of the accident) and has no problems swallowing. We moved her to our home state and into an acute rehab center where she was to receive intense physical therapy to get her mobile around the house so that she and my dad could come live with us permanently. After a week in the rehab center the skin graft site became so nasty that I told them if they did have her taken to the ER I was calling 911 myself. About 2 hours later she was taken to the local hospital where she was admitted with a severe infection of the wound and a blood infection. At some point she was prescribed oxycontin (two different doses). My family has explained numerous times that the females in our family have a very low tolerance for drugs of an type and that we felt that she was being overdose. My mother is now loopy, hallucinating, trys to get out of bed, and has actually fallen out of bed atleast once that I was made aware of. I believe that my mom is in pain from her injuries however I don't feel that the pain is severe or chronic. She has a horrible wound that is going to take months to heal and being 80 her circulation is not real good so healing is slow, however, she doesn't really complain that much about pain. Last night she asked for something for pain when she was put to bed for the night, I asked the nurse to give her tylenol instead of the oxycontin because I felt that she just need something mild to take off the edge. When I called this morning to see how she did last night I was told that she was given the oxycontin at 8PM. I know this is a lie becuase of I was there from 7:30PM until 9:15PM and she received no medications at all during that time. I reported this to the charge nurse and the social worker and received a call from the evening nurse that she had recorded the wrong time but my mom had received the medications. Now I'm wondering: Was the time recorded wrong? Was my mom given the oxycontin? Or did someone else get or take the oxycontin? Any of these scenarios is scary to me! I'm in the process of getting my mom moved to a different facility, not becuase I think the care will be any better or worse but becuase it will be closer to my home and as a family we will be able to monitor her easier. We go to see her everyday, work with her to get her up and out of bed but know that she isn't ready to come home yet. My heart goes out to patients that don't have the support of a family and have to live in these rehab centers. I feel that pain and sleep drugs are handed out like candy and are used to sedate patients so that they can be left laying in a bed. This is very sad, up until the time of my mom's accident she was very active in the Elks Lodge, kept her own house, did her own shopping, etc. Now they want to give her and my dad something for depression. I don't know about you, but I think they have alot to be depressed about right now, moving from their home of 18 yrs., dealing with my mom's accident. I don't think more medication is the answer. Sorry for this long story, I am just so upset and saw this site when I was trying to find out more about oxycontin.

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