FDA & Prescription Drugs | InjuryBoard Orlando

Bayer AG has failed to disclose to regulators potentially serious safety concerns about its antibleeding drug Trasylol. The FDA has disclosed that preliminary test results indicate that the drug may cause serious kidney damage, congestive heart failure and strokes and an increased risk of death.

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Physicians' financial interests should not overtake the needs of a patient when it comes to dealing with drug and medical device manufacturers. This was the obvious conclusion arrived at by a group of bio-ethicists at a conference hosted by Cleveland Clinic and sponsored by the National Institutes of Health. The recent spate of ethical issues over doctors' involvment with drug and device...

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According to a published report in the Wall St. Journal, Glaxo Smith Kline became the latest drug manufacturer to add a warning label to its ADHD drug, Dexedrine. The new warning label will include a warning about cardiac risks and psychiatric side effects. The new warning was posted on the FDA website yesterday.

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A New Orleans jury returned a $50,000,000 award to a 62 year old plaintiff who had taken Vioxx for 31 months. Mr. Barnett had suffered a heart attack four years earlier and stopped taking the drug shortly before Vioxx was pulled from the market. The jury found that Merck failed to adequately warn doctors about Vioxx's potential harmful side effects and risks for cardiac incidents.

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Since the initial news broke about a link between the arthritis drug Fosamax and jaw bone death or osteonecrosis, a panel of medical and pharmacological experts has been convened to study the issue. In most instances, the resulting jaw bone death has occurred after Fosamax patients have had dental surgery or tooth extraction. As a result of the panel discussions, a new moniker for the...

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A drug touted as an effective treatment of epilepsy has been shown to cause birth defects or fetal death in cases where mothers were taking the drug during pregnancy. The birth defects include malformed hearts and genitals, cleft palate, and artery deformities among children born to women taking Depakote. The rate of serious adverse outcomes for the other anti-epileptic drugs (AEDs) tested was...

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At a recent political fundraiser I heard a congressman refer to the pharmaceutical industry as the "101st Senator" in the United States Senate. He was commenting on the tremendous influence that this industry holds over our elected officials in Washington. The pharma industry throws its influence and big bucks around the halls of power whenever a bill is introduced for consideration. In a...

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There was an interesting article published this morning in the NY Timesregarding osteoporosis drugs and osteonecrosis. According to the article, two groups of people take the osteoporosis drugs which belong to the bisphosphonate family. The first group, those suffering from breast cancer and/or multiple myeloma whose disease has spread to the bone, receive the drug intravenously. The second...

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Citing a growing number of deaths related to liver failure, the FDA has called for a stronger warning label for the antibiotic drug KetekThe FDA has received reports of 12 cases of acute liver failure, including the four deaths, in patients treated with Ketek, according to a copy of an FDA memo. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries...

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While physicians say they're rare, Fosamax users can be susceptible to "dead jaw" disease or commonly known as jaw rot. Fosamax, an osteoporosis drug belonging to the bisphosphonate family, can lead to "dead jaw" syndrome -- a painful condition that causes ulcers, tooth loss and exposed bone. But while cancer patients appear more at risk, Dr. Bruce Pihlstrom of the National Institutes of Health...

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US Senate Finance Committee Chairman Charles Grassley (R-IA) has called on the maker of Ketek, Sanofi-Aventis, to produce its investigator as part of a probe of the company's handling of the antibiotic. The letter released last night by Mr. Grassley, an Iowa Republican, is the second one he has sent to the FDA about the drug, which is made by Sanofi-Aventis SA. He told the agency he wants to...

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The FDA said yesterday that ReNu maker Bausch & Lomb failed to promptly report 35 cases of the fusarium keratitis infection. The failure to inform the FDA within a 30 day time period is part of a larger list of 20 violations the FDA listed after inspecting the Greensville, SC plant.

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I was quoted in today's Boston Globe as a result of Bausch & Lomb's decision to halt permanently the worldwide sales of its ReNu with MoistureLoc. As the paper stated, I think the decision confirms what we've suspected all along, namely, that the problem lies in the solution itself.

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In spite of a sharp increase in fungal infections among users of ReNu with MultiPlus, Bausch & Lomb has not removed the eye contact solution product from store shelves. US health officials have now confirmed more than 120 cases of a potentially blinding eye infection that may be related to contact lens use.

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A new Merck & Co. study reveals that risk for heart attacks and strokes continues even when its use is discontinued. This risk continues for a year after use. In spite of the new study, Merck says it won't change its litigation strategy. Oh well, why be confused with the facts.

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