- Scott Kappes | January 31, 2008 11:34 AM |
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FDA & Prescription DrugsA Texas researcher has admitted that he leaked a copy of the now infamous New England Journal of Medicine article that tied Avandia to an elevated heart risks. Steven Haffner of the University of Texas Health Science Center at San Antonio conceded that he faxed a pre-publication copy of the report to GlaxoSmithKline (GSK), the makers of Avandia, 17 days before the article was published. Haffner...
- Scott Kappes | January 29, 2008 10:03 AM |
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FDA & Prescription DrugsYesterday Pfizer announced that it had received approval from Japan's Ministry of Health, Labor, and Welfare to manufacture and market the popular stop smoking aid known as Chantix in the US. The drug will be marketed as Champix in Japan, as it is in the UK and EU. This will be the first oral smoking cessation aid availible in Japan and Pfizer expects it to be very popular among Japanese smokers...
- Scott Kappes | January 25, 2008 3:46 PM |
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FDA & Prescription DrugsToday I came across yet another story that appears to link Pfizer's blockbuster stop smoking aid Chantix, marketed as Champix in the UK, to an increased risk of suicidal thought and behavior. The horrifying story of a 38-year-old UK woman taking Chantix who tried to take her own life with no recollection of the event is one of the most disturbing accounts that I have come across. Karen McGhee...
- Scott Kappes | January 22, 2008 5:19 PM |
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FDA & Prescription DrugsThis week Pfizer announced a label change for the popular smoking cessation medication Chantix in the U.S. due to increased concern of a possible link between the drug and suicidal thought and behavior. Just as this news hits the U.S. the United Kingdom is rattled by the news of yet another suicide being linked to Champix, the marketing name for Chantix in the UK. A 36-year-old welder and father...
- Scott Kappes | January 22, 2008 10:52 AM |
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FDA & Prescription DrugsThe New Jersey attorney general has subpoenaed drug maker, Amgen, following allegations of patient privacy law and marketing violations concerning the rheumatoid arthritis drug Enbrel. Former sales reps have made claims that they were pushed make attempts at accessing patient medical information and to market directly to patients. Amgen says that the claims have no merit and that their reps have...
- Scott Kappes | January 21, 2008 11:48 AM |
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FDA & Prescription DrugsOn Friday Pfizer announced that a labeling change for the popular stop smoking drug Chantix. The FDA is conducting an ongoing investigation of the drug and its possible link to suicidal thoughts and other psychological effects. The label has been altered to reflect the fact that some patients may experience "serious nueropsychiatric symptoms" including but not limited to suicidal behavior....
- Scott Kappes | January 18, 2008 12:13 PM |
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MiscellaneousOn January 15 Kathy Addison of Port Arthur, TX filed a personal injury lawsuit claiming that a defect in the Luby's parking lot caused her to trip and consequently injure her elbow. The lawsuit alleges that Luby's Inc. was negligent in failing to maintain a safe premises. The suit claims that the parking lot posed an unreasonable risk and the obvious defect should have been repaired to create a...
- Scott Kappes | January 17, 2008 1:07 PM |
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FDA & Prescription DrugsToday the FDA issued a warning that parents should not give toddlers over the counter cold and cough medicines. The agency says that these drugs are too dangerous for children less than two years of age. The agency has yet to decide whether OTC cold medications are appropriate for older children, but a decision can be expected in this matter sometime this spring. The warning was prompted by the...
- Jenny Albano | January 16, 2008 4:17 PM |
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Tractor-Trailer AccidentsThe family of a man who was killed in a recent bus crash near Victoria is suing the bus owner, the operator and the driver of the vehicle. Pedro Mendez was killed during the accident that occurred on January 2 that seriously injured many other passengers. The bus was headed to Houston from Monterrey, Mexico.The lawsuit, filed Tuesday in Harris County District Court, alleges three companies...
- Scott Kappes | January 16, 2008 2:20 PM |
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FDA & Prescription DrugsOn Monday the United States Supreme Court refused to hear an appeals case involving terminally ill patients' constitutional rights to experimental dugs that have not been approved by the FDA The case was originally filed 2003 when the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs initiated a claim that the FDA's policy of restricting terminally ill...
- Scott Kappes | January 15, 2008 5:02 PM |
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FDA & Prescription DrugsA group of professional doctors has petitioned the FDA to add additional information to the label of the controversial type-2 diabetes drug Avandia. The request may surprise you as it did me. They are not petitioning to place another warning about heart failure or the increased risk of heart attack that has been so widely publicized in recent months, but rather to encourage diabetics to adopt a...
- Scott Kappes | January 11, 2008 4:21 PM |
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Medical MalpracticeThe U.S. Centers for Disease Control and Prevention is encouraging women to make sure they take in 400 micrograms of folic acid each day. This week is National Folic Acid Awareness Week and the CDC has taken this opportunity to make more women aware of the benefits of folic acid. Folic acid is a B vitamin the has been shown to prevent birth defects. The National Council on Folic Acid estimates...
- Scott Kappes | January 10, 2008 5:18 PM |
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FDA & Prescription DrugsA study of 19 industrialized nations ranked the United States worst in preventable death statistics. The report is published in this months issue Health Affairs and compares trends from 1997-8 and 2002-3 of people under 75 years of age whose deaths were classified as "amenable to health care," or preventable with appropriate health care. The study shows the United states falling well behind the...
- Scott Kappes | January 07, 2008 5:17 PM |
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FDA & Prescription DrugsToday the FDA issued a warning of severe pain associated with a class of osteoporosis medicines known as bisphosphonates. This class includes popular medications Fosomax and Actonel. The potential for severe and even incapacitating bone, joint and muscle pain is listed in the prescribing information, but is commonly overlooked because it may occur within days, weeks, or even years after a...
- Scott Kappes | January 07, 2008 9:32 AM |
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FDA & Prescription DrugsLawyers for thousands of people injured by Merck's recalled painkiller Vioxx are challenging a specific provision of the $4.85 billion settlement proposed in November. The provision in dispute requires lawyers representing injured parties to advise either all of their clients to accept the settlement or none of their clients to accept the deal. This is a quite perplexing ethical situation for...
- Jenny Albano | January 02, 2008 8:06 PM |
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Tractor-Trailer AccidentsA Mexican tour bus collided with a truck on Wednesday, January 2, killing one and injuring several others. The charter bus, carrying almost 50 passengers, veered off the highway and then over-corrected, which caused the bus to tip over onto its side. Then, once the bus had crashed on U.S. 59 near Victoria, a pickup truck collided with the overturned bus. The driver of the pickup was not...
- Scott Kappes | January 02, 2008 11:02 AM |
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FDA & Prescription DrugsMany people will have made their New Year's resolution to quit smoking, but some could be getting more than they bargained for. People who want to quit smoking will try every remedy available from gum and lozenges to prescription medications like Zyban and Chantix. Most people have seen better results from prescriptions than other methods, but even these are not free from risk. Recent reports...