Radiation Exposure from CT Scans More Dangerous Than Previously Thought
Recently, it was reported that radiation overexposure from CT scans may be more severe than health care professionals previously thought. Research from two new studies published in the Archives of Internal Medicine has found that patients may be exposed to four times more radiation than estimated by prior studies. The studies caution against the overuse of CT scans, as well as other medical technologies using radiation, including mammograms.
The studies also found that there is a large variation in the amount of radiation patients receive from the most common types of CT scans, those of the abdomen, pelvis and chest. A survey of four hospitals revealed that some patients received 13 times more radiation than others for the same type of scan. Researchers stated that the large differences between scans may be attributed to the lack of standardized settings in CT technology, as well as differences in how the doctors use the technology for each patient. CT scans are able to produce images of the body that offer more detail than x-rays, and their use has more than tripled to 70 million since the 1990s.
Ultimately, the studies determined that the 72 million CT scans currently performed yearly in the U.S. could lead to 29,000 more cases of cancer and 15,000 more deaths a year. The most common type of predicted radiation-associated cancer is lung cancer, followed by colon cancer and leukemia. On December 7, 2009 the FDA issued interim regulations requiring closer monitoring of CT scans. These regulations came after more than 250 cases of exposure to excess regulation were reported over the past two years.
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Label Changes Mandated for Pain Pumps Due to Dangers of Permanent Cartilage Damage
A recent report from the Wall Street Journal stated that the FDA is seeking to change labels on pain pumps that deliver pain medication to patients after surgery. Pain pumps are small plastic tubes that deliver and regulate pain medication, usually for a couple of days. The proposed label changes come in the wake of many reports of irreversible cartilage damage from patients who had the medication delivered to their joints, primarily after shoulder surgery. Doctors say that after a procedure like shoulder surgery, the pain pumps can provide too much medication to the tissue, resulting in severe and permanent damage.
From 2006 to 2008, the FDA states that it has received 35 reports of severe cartilage damage from these pumps. Manufacturers of the pumps include I-Flow Corp., Stryker Corp, and Moog Inc., and the FDA has given them 30 days to update the warning labels to account for potential cartilage damage. The pain pumps in question have been approved by the FDA for use after abdominal and certain other surgeries, but not after joint procedures like shoulder surgery.
Hundreds of cases have already been filed against these companies due to the severe cartilage damage many patients have experienced. If you or a loved one has used a pain pump and sustained cartilage damage, contact the personal injury attorneys at the Pintas Law firm immediately. We can provide you with a free no-obligation consultation and explain your legal rights to you.
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Tysabri Injury Lawyers
Tysabri Leads to Rare and Deadly Disease
Tysabri is a drug that is used to treat relapsing forms of multiple sclerosis, a disease of the nervous system in which the body’s immune response attacks one’s central nervous system. Tysabri is also marketed to treat severely active Crohn’s disease, a disease in which the body’s immune system attacks the gastrointestinal tract. Thousands of users each year take Tysabri to combat these two serious illnesses. Since the drug has been on the market, the FDA has received numerous reports of users of Tysabri developing progressive multifocal leukoencephalopathy (PML), which is a rare and usually fatal viral disease that has no known cure.
Tysabri and Progressive Multifocal Leukoencephalopathy
Progressive multifocal leukoencephalopathy is characterized by progressive damage or inflammation of certain areas of the brain. Tysabri was pulled from the market due to safety concerns in 2005, a year after it was introduced. Before it was pulled from the market in 2005, it had led to three confirmed cases of PML, and two resulting deaths.
However, it was re-introduced to the market in 2006 with more stringent regulations. Despite these precautions, there have been 13 FDA-confirmed cases of deadly Tysabri-related PML in patients who were being treated for multiple sclerosis since the drug was re-introduced. The risk of developing PML increases with the number of Tysabri infusions received.
Contact the Injury Attorneys at the Pintas Firm
If you or a loved one has suffered from progressive multifocal leukoencephalopathy as a result of using Tysabri, please contact an injury attorney at the Pintas Firm immediately. However, do not discontinue your medication unless you have checked with your physician first.
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FDA Places Suicide Warnings on Antidepressants
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide."
Read the FDA's full press release here.
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FDA Warns of Triptan and SSRI Combination
Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea."
Read the FDA's full warning here. Posted In FDA Warnings
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FDA Warns of Viagra Like OTC Drugs
The FDA warned consumers not to buy or use seven of the so-called dietary supplements sold online to treat impotence and enhance sexual performance. The list includes Zimaxx, which FDA testing showed contains sildenafil, the same active ingredient in Viagra. Viagra, made by Pfizer Inc., is sold in the United States only by prescription."
Read the full article in the LA Times here.
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Severe Asthma Attack Warnings for Serevent
The FDA recently asked the makers of Serevent Diskus, Advair Diskus, and Foradil Aeolizer to update thier labels to include risk of severe asthmatic attack. The drugs work to keep asthma episodes to a minimum with a medicine called "long-acting beta 2-adrenergic agonists" (LABA). All asthma drugs with this medicine will include this warning.
The problem is the drugs lower the frequency of asthma attacks, but actually greatly increase the severity of an attack when they occur. There is at least one death reported from the use of these drugs.
Read FDA's statement here.
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Blood Clots Linked to Ortho Evra Birth Control Patch
Earlier this month, the FDA added a new warning to the popular Ortho Evra birth control patch. The patch exposes its users to a large amount of hormones which cause blood clots and other serious side effects.
According to records at MedWatch, about a dozen women in their late teens and early twenties died in 2004 from massive blood clots believed to be related to the birth-control patch. Dozens more had similar but non-lethal strokes and other clot related problems.
The warning comes nearly four months after an Associated Press report told of patch users die and suffer blood clots at a rate three times higher than woman taking the pill.
Read the FDA's FAQ page here.
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Safety Warnings Regarding Duragesic Skin Patches
The FDA recently released a warning to patient and caregivers regarding the use of the Duragesic patch for pain control. Deaths and overdoses have occurred with Duragesic and the generic form of the drug. The complete warning may be found here.
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FDA Places Warnings on Viagra, Cialis, Levitra
The FDA recently asked the makers of the most popular erectile dysfunction drugs to add label warnings for sudden vision loss. The blindess associated with these drugs is caused by non-arteritic ischemic optic neuropathy or NAION. This warning comes in the wake of recent problems with Viagra. The warning is to be placed on Viagra, Cialis, and Levitra.
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FDA Warns of Suicide Risk with Common Antidepressants
FDA recently released a warning for antidepressants such as Effexor, Paxil and Zoloft. The warning is for suicidality, especially with adults taking these drugs for depression.
These drugs received a similar warning for use in children in March of 2005.
Read the FDA Healthcare and Patient information sheets here.
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FDA Issues Warning on Cox-2 Inhibitors and NSAIDs
The FDA announced today that they are requiring a boxed warning be placed on all Non-Steroidal Anti-inflammatory Drugs (NSAIDs) including all Cox-2 inhibitors. The warning notifies patients of cardiovascular and gastrointestinal risks. The FDA warning includes popular over-the-counter NSAIDs, such as Aleve, Advil and Motrin.
This warning comes with little surprise, as indictors of a cardiovascular risk for NSAIDs have been around for years. The concern is that these warnings are too little too late.
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More Fodder for All Bark No Bite FDA Black Box Warnings
A recent article in the USA Today looked into the effectiveness of the FDA's black box warning. This is the most stringent warning the FDA can place on a drug, and most recently placed the warning on antidepressants and the arthritis drug Celebrex...
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FDA Warnings: All Show No Substance
On April 7, 2005, the FDA required Pfizer to put a "black box" warning on Celebrex labels. This is the strongest warning available to the FDA, and requires doctors to prescribe Celebrex as a last resort for patients suffering from pain. The drug is also contraindicated for those post-coronary artery bypass surgery.
This all sounds good, but the fact is that many doctors and patients will never receive this warning. Even with all the news surrounding Celebrex and the entire class of Cox-2 Inhibitors, some doctors and many patients are too busy to read and understand the new warnings. "Dear Healthcare Professional" letters are sent out to doctors for every label change. There is a serious question how many doctors have the time in their busy schedules to actually read all of them.
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More Cox-2 Chaos
In February, an FDA advisory committee met to discuss the safety of the class of drugs known as Cox-2 inhibitors. Of course, this is the class getting a lot of press lately that includes Vioxx and Celebrex. Pfizer and Merck pharmaceutical companies where there, defending their drugs and making their plea to keep their money-makers on the market.
At the conclusion of the three day seminar, the 32 member panel voted on a variety of issues including whether these drugs increase the risk of heart attack and stroke, and if the drugs should be allowed to stay on the market. The panel voted unanimously that all Cox-2's increase the risk of cardiovascular events (a fact that Pfizer continues to deny to this day). More surprisingly, the panel also voted 17 to 15 in favor of letting Vioxx return to the market. The decision was summed up on the front page of the Chicago Tribune: "Vioxx Returns to the Market." (A bit of irresponsible journalism, but that is another post for another day).
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Where is the FDA?
We have been bombarded this holiday season with bad news. Drugs distributed on a mass scale have the ability to actually kill its users. Vioxx, Celebrex, and Bextra, all members of a class of drugs called Cox-2 inhibitors, are the problem.
The first to fall is Vioxx. Merck Pharmaceuticals withdrew Vioxx from the market after a study indicated a two fold risk of heart attack with people who use the drug. About a month later, a similar study is halted when it is discovered that those on Celebrex have a 2.5 increase risk of heart attacks and strokes. Other studies indicate a similar problem with Bextra...
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