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Cardinal Stops Production of Defective Drug Pump after FDA has U.S. Marshalls Confiscate Devices

Cardinal Health announced that it stopped production of four Alaris drug infusion pumps. The announcement came after the FDA requested that U.S. marshals confiscate 1,300 devices out of the company’s San Diego facility on Friday. The Alaris pumps, which are used to regulate the delivery of intravenous drugs to patients, have been linked to at least two deaths due to an oversensitive keypad.

According to the FDA the defect in the keypad causes “key bounce,” which occurs when a number entered into the keypad is recorded more than once. If the intended dose is 3.5 milliliters per hour, the defective keyboard could actually enter 33.5 milliliters into the pump, and can cause a serious overdose.
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Workers Exposed to Lead are 50 Percent More Likely to Die from Brain Cancer than those not Exposed

Occupational exposure to lead dramatically increases the risk of devloping and dying from brain cancer, according to a report published in the International Journal of Cancer. The report by leading epidemiologists analyzed over 300,000 workers and found the riskiest occupations were welders, auto mechanics, heavy equipment mechanics. Individuals heavily exposed to lead at work were more than two times as likely to die from brain cancer as nonexposed workers.
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Bausch & Lomb ReNu with MoistureLoc Recall History

ReNu with MoistureLoc was removed from the market after the CDC discovered numberous cases of fusarium keratitis were linked to the product. The recall has slowed the outbreak of the fungal eye infection but it is estimated that MoistureLoc still holds over 2 percent of the market, because many people are still unaware that the solution has been recalled. Below is a detailed timeline of Bausch Lomb’s ReNu with MoistureLoc.

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution:
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Internal Memos on Hormone Replacement Therapy Drugs Prempro and Premarin May Hurt Wyeth

Wyeth may have known as early as the 1970’s that its hormone replacement drug, which later became Prempro, was associated with a high rate of breast cancer. According to recent published reports, Wyeth researchers saw cancer risks associated with hormone-replacement drugs as early as 1976. These concerns were brought to the attention of Wyeth executives several years later in the form of an internal memo. This memo alerted Wyeth executives that the FDA’s request for more extensive safety testing of Prempro could publicly reveal the drugs link to breast cancer.
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Important Mesothelioma Research Foundation Receives Federal Funding

For the first time ever, federal funds have been given to a nonprofit group dedicated to eradicating mesothelioma. The Mesothelioma Applied Research Foundation (Meso Foundation), said it received  federal research funding from the Department of Defense Peer Reviewed Medical Research Program and National Institute for Occupational Health and Safety (NIOSH). Mesothelioma is a deadly disease that is most commonly associated with asbestos exposure. Workers in certain occupations, including shipyard workers and auto works, are among the hardest hit with mesothelioma.
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Study Finds Use of Common Painkillers in First Trimester May Cause Birth Defects

A study published in the journal, Birth Defects Research Part B found that the use of non-steroidal anti-inflammatory drugs (NSAIDs) during the first trimester of pregnancy can cause congenital birth defects. NSAIDs are commonly used pain medications that include aspirin, ibuprofen, cox II inhibitors and naproxen sodium. Popular brands of NSAIDs are Bayer, Advil, Motrin, Aleve and Celebrex. While the study found these medications can lead to several congenital defects, heart defects were the most common.
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Woman Injured by Ortho Evra Birth Control Patch Files Suit

A 34 year-old Idaho woman that was diagnosed with a severe pulmonary embolism after using the Ortho Evra birth control patch filed a lawsuit against the drugs manufacturer Ortho Mc-Neil Pharmaceutical, Inc. The woman used Ortho Evra for less than two years according to a press release issued today by the woman’s law firm Parker & Waichman, LLP.

The woman suffered a large pulmonary embolus in her right upper lobe involving a secondary order vessel that extended into two third order vessels. The woman was hospitalized for six days and may be require the use of anticoagulant medications for the rest of her life. The case is the most recent suit by women who claim the birth control patch caused serious life threatening injuries. Numerous suits have already been filed against the Ortho-McNeil, a subsidiary of Johnson & Johnson, that allege Ortho Evra caused pulmonary embolism, deep venous thrombosis, stroke, heart attack and death.
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CDC Report on ReNu with MoistureLoc May Exacerbate Legal Problems for Bausch & Lomb

CDC researchers believe that the global recall of Bausch & Lomb’s ReNu with MoistureLoc has stopped the outbreak of fusarium keratitis, a serious fungal eye infection. However, the CDC report stated that poor hygiene was not the sole cause of the fungal infections, and said that the contact lens solution appears unable to adequately disinfect contact lenses. While the recall has potentially saved thousands from future infection, the CDC research may have hurt Bausch & Lomb’s ability to defend itself in numerous lawsuits filed against the company. Analysts have estimated Bausch & Lomb faces $500 million to $1 billion in potential liability from the infections, but many plaintiff attorneys believe the liability is much greater.
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One-Third of Infected ReNu with MoistureLoc Users Needed Corneal Transplants

A research report issued by the Centers for Disease Control and Prevention revealed that one-third of patients with a serious eye infection associated with Bausch & Lomb’s ReNu with Moistureloc contact-lens solution had such severe infections that they had or will need a corneal transplant. The research report will appear in the Aug. 23/30 edition of the Journal of the American Medical Association.

ReNu with MoistureLoc, was removed from worldwide markets in May after it was linked to several cases in the United States and Asia of fusarium keratitis, a serious fungal infection that can cause blindness.Between June 1, 2005 and June 30, 2006, the CDC said it identified 164 confirmed cases of fusarium keratitis in the U.S. Of those, 94 people reported using ReNu with MoistureLoc and another 21 people reported using that solution along with others to clean their contact lenses. The May CDC report confirmed 130 cases of the eye infection in the United States. Researchers said 55 people either underwent or planned to have a corneal transplant as a result from damage caused by the infection.
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Glaxo Adds Black Box Warning ADHD Drug Dexedrine

GlaxoSmithKline Plc has added a black box warning about possible heart risks to its popular ADHD drug Dexedrine. The drug’s packaging will also include information about possible psychiatric adverse events, like hallucinations and mania, linked to stimulants, according to the letter posted on the FDA website. A “black box warning” is the strongest warning a medications warning label can have. Dexedrine is known generically as Dextroamphetamine.
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