- Trasylol (aprotinin injection)
[UPDATE 05/14/2008] Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
[Posted 11/05/2007] FDA announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study’s researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
Previous MedWatch Alert:
Trasylol Deaths & Injuries – Drug Side Effects and Recall
Thought to be the next billion-dollar drug for pharmaceutical giant Bayer, Trasylol was designed to control bleeding during heart surgery. As early as the 1980s, warnings from drug researchers indicated that the drug may cause deadly side effects. However, these reports did not derail Bayer’s tenacious pursuit of FDA approval and worldwide distribution of Trasylol. The negligent release of Trasylol despite health warnings has caused thousands of patients worldwide to suffer serious injury and/or death. The personal injury lawyers and wrongful death attorneys at Phillips & Associates are dedicated to helping injured victims and their families file lawsuits against Bayer in order to obtain justice and rightful financial compensation.
ASSALAMMULAIKUM DAN SELAMAT SEJAHTERA.
SEKIRANYAN DI NEGARA MAJU TELAH DILANDA MASALAH SEPERTI DI BAWAH,INIKAN PULA DI MALAYSIA??
APAKAH TINDAKAN KITA SEBAGAI RAKYAT MALAYSIA? MENANTI MASALAH YANG SAMA MELANDA KITA ATAU KITA MEMBUAT SESUATU UNTUK MENJAGA DIRI DAN KELUARGA KITA.
TERPULANG UNTUK ANDA TENTUKAN.KEPUTUSAN DI TANGAN ANDA.
ATLANTA – The current flu season has shaped up to be the worst in four years, partly because the vaccine didn’t work well against the viruses that made most people sick, health officials said Thursday.
This season’s vaccine was the worst match since 1997-1998, when the vaccine didn’t work at all against the circulating virus, according to the Centers for Disease Control and Prevention.
The 2007-2008 season started slowly, peaked in mid-February and seems to be declining, although cases are still being reported, CDC officials said.
Based on adult deaths from flu and pneumonia, this season is the worst since 2003-2004 — another time when the vaccine did not include the exact flu strain responsible for most illnesses.
Each year, health officials — making essentially an educated guess — formulate a vaccine against three viruses they think will be circulating. They guess well most of the time, and the vaccine is often between 70 and 90 percent effective.
But this year, two of the three strains were not good matches and the vaccine was only 44 percent effective, according to a study done in Marshfield, Wis. That seemed to match the experience in other parts of the country.
“We’ve had a pretty heavy season, both adult and pediatric. And there were a good number of cases — more than usual — who had received a vaccination,” said Dr. Niranjan Bhat, a children’s infectious disease specialist at Johns Hopkins Hospital in Baltimore.
The CDC compares flu season by looking at adult deaths from the flu or pneumonia in 122 cities. This year, those deaths peaked at 9 percent of all reported deaths in early March, and remained above an epidemic threshold for 13 consecutive weeks. In 2003-2004, they peaked at more than 10 percent of all deaths, and surpassed the epidemic threshold for nine weeks.
“Our season is not quite as high but is lasting a little longer,” said Dr. Dan Jernigan, deputy director of the CDC’s influenza division.
Pediatric deaths are another way flu seasons are compared. So far this season, 66 children died, including 46 who were not vaccinated. In 2003-2004, 153 children died.
Each year, the flu results in 200,000 hospitalizations and 36,000 deaths, according to official estimates. The elderly, young children and people with chronic illnesses are considered at greatest risk.
The CDC started working with the Marshfield Clinic in central Wisconsin to get a better gauge of vaccine effectiveness while a flu season was in progress. Almost the entire population in the Marshfield area — about 50,000 people — gets health care at clinic offices, which has complete vaccination and electronic medical records.
This year, most of the illness has been due to Type A H3N2 Brisbane strain, which was not in the vaccine. That strain tends to cause more hospitalizations and deaths, contributing to this season’s severity, CDC officials said.
Type B Florida strain, also absent from this year’s vaccine, has also been causing illness. Marshfield data showed that the vaccine was completely ineffective against the Type B virus, and was 58 percent effective against the Brisbane virus.
Jernigan acknowledged that some people may lose faith in the flu vaccine and skip it next year. But he noted even this year’s mismatched vaccine still offered 44 percent protection overall and likely reduced the severity of illness in those who got the flu.
The Marshfield study and a flu season update are being published this week in a CDC publication, Morbidity and Mortality Weekly Report.
APABILA ANDA INGIN KELIHATAN MENAWAN,CANTIK,DAN MENARIK HATI,SILA PASTIKAN KAN ILMU ANDA ADA BERKENAAN APA YANG ANDA PAKAI UNTUK KECANTIKAN.
SILA BACA DENGAN KEFAHAMAN KERANA MUNGKIN IANYA BOLEH MENYELAMATKAN NYAWA ANDA DAN ORANG SEKELILING ANDA.
February 3, 2005 the Food and Drug Administration issued an unprecedented warning to the cosmetics industry stating that the Agency is serious about enforcing the law requiring companies to inform consumers that personal care products have not been safety tested. When risky chemicals are used in cosmetics, the stakes are high. These compounds are not trace contaminants. They are the base ingredients of the product, just as flour is an ingredient in bread. Many of these chemicals are found in percent levels in personal care products, nearly all easily penetrate the skin, and some are ingested directly after they are applied to lips or hands. And increasingly, companies are adding customized, futuristic “penetration enhancers” to drive ingredients even deeper into the skin, like Loreal’s new nanoparticle technology — a miniscule, fluid-filled sack designed to burrow deep into the skin to deliver its “active ingredients.” No safety testing required. Scientists find common cosmetic ingredients in human tissues, like industrial plasticizers called phthalates in urine, preservatives called parabens in breast tumor tissue, and persistent fragrance components like musk xylene in human fat. Do the levels at which they are found pose risks? Those studies have not been done. They are not required.
Make-up and body care products contain ingredients suspected of causing cancer; potential neuro-, liver-, and immunotoxins; and suspected hormone disruptors that could cause birth defects in any children she might bear in the future. Many consumers may be surprised to learn that the US federal government doesn’t require health studies or pre-market testing on personal care products. Manufacturers are free to put just about anything they want into cosmetics—a far-reaching category used by the US Food and Drug Administration (FDA) to include everything from make-up and deodorant to lotions and mouthwashes.
Instead, the safety (or not) of the ingredients in these products is looked into almost exclusively by a manufacturer-controlled safety committee called the Cosmetic Ingredient Review (CIR) panel. Consequently, “89 percent of 10,500 ingredients used in personal care products have not been evaluated for safety by the CIR, the FDA, nor any other publicly accountable institution,” says the nonprofit Environmental Working Group (EWG). “The absence of government oversight for this $35 billion industry leads to companies routinely marketing products with ingredients that are poorly studied, not studied at all, or worse, known to pose potentially serious health risks.”
For example, EWG found ingredients certified by the US government as “known or probable carcinogens” in one of every 120 cosmetic products on the market, including shampoos, lotions, make up foundations, and lip balm. What this adds up to, says the group, is that “one of every 13 women and one of every 23 men are exposed to ingredients that are known or probable human carcinogens every day through their use of personal care products.”
Also of particular concern are the inclusion of phthalates—a group of industrial chemicals linked to birth defects that are used in many cosmetic products, from nail polish to deodorant. Phthalates are not listed as ingredients on product labels; they can only be detected through laboratory analysis. In April of this year, the Campaign for Safe Cosmetics (CSC)—a coalition of environmental, social justice, and consumer groups—learned that the FDA has completed a study on the safety of phthalates in cosmetics but is refusing to release its findings. According to preliminary information uncovered by the CSC, two-thirds of health and beauty products analyzed by the FDA late last year contained phthalates. Two of the most toxic phthalates, DBP and DEHP, have been banned from cosmetics products sold in the European Union (EU) but remain unregulated in the US. In response to the FDA’s refusal to publicly release this information, Friends of the Earth, a founding member of the CSC, has filed a Freedom of Information Act request to obtain the study.
Another class of chemicals that’s gotten some press recently is parabens, short for “para hydroxybenzoate.” These preservatives are widely used in cosmetics, particularly nail polish. Recent studies have implicated parabens as being associated with breast cancer, though more testing is needed.
Though there isn’t always definitive evidence that a given chemical can cause adverse health affects, the fact that so few have been studied for safety is of significant concern. Plus, there’s the effect over time of all these chemicals we’re applying to our bodies to consider. The average person’s morning routine puts him/her into contact with over 100 chemicals before breakfast, according to Aubrey Hampton and Susan Hussey, founder and vice-president of marketing, respectively, of Aubrey Organics. The cumulative effect of all of the chemicals in these products can add up over time, and no one truly knows what the results are.
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