FDA & Prescription Drugs

• Should TV Drug Ads Carry FDA Contact Info?

  Scott Kappes | April 03, 2008 12:25 PM | 0 CommentsHouston, TX

  The Consumer Union advocacy group has petitioned the FDA to require television prescription drug advertisements to include a toll free number and a website address where consumers can report adverse...

• FDA Deadlines May Affect Drug Safety

  Scott Kappes | March 28, 2008 2:55 PM | 0 CommentsHouston, TX

  According to a study published in the New England Journal of Medicine deadlines for response to new drug applications may be causing the agency to make hasty decisions. The study suggests that drugs approved closer to the deadline end up having more safety issues once on the market than drugs that are approved earlier in the process. The study shows that of the 97 drugs that were approved within...

• FDA To Investigate Singulair-Suicide Link

  Scott Kappes | March 27, 2008 1:50 PM | 0 CommentsHouston, TX

  Today the FDA announced that they would be launching a probe to investigate a possible link between Merck's asthma medication Singulair and suicidal ideation and action. The agency is reviewing the issue due to reports of mood and behavioral changes, including suicidal thoughts and action, associated with the drug. Singulair is most commonly used to treat asthma but is also often used to treat...

• Gadolinium Based Contrast Agent Prompts Lawsuit

  Scott Kappes | March 17, 2008 3:55 PM | 0 CommentsHouston, TX

  A San Francisco couple has filed a lawsuit against Bayer and other drug manufacturers alleging that gadolinium based contrasted agents manufactured and distributed by the Defendants can cause patients to develop a severely painful and debilitating disease. William Paschal claims that he contracted Nephrogenic Systemic Fibrosis (NSF) from an intravenous injection of a gadolinium based contrast...

• Connecticut Sues Zyprexa Maker

  Scott Kappes | March 11, 2008 3:31 PM | 0 CommentsHouston, TX

  Today the state of Connecticut filed a lawsuit against Eli Lilly and Co. The lawsuit accuses the company of illegally marketing and obscuring negative side effects of the best selling drug Zyprexa. The lawsuit seeks to recover money spent on treating patients that have developed conditions as a result of taking Zyprexa and millions more spent on the drug as a result of illegal marketing...

• Lawyer For Alaska Says Eli Lilly Hid Zyprexa Risks

  Scott Kappes | March 07, 2008 11:23 AM | 0 CommentsHouston, TX

  In an ongoing trial between the State of Alaska and Eli Lilly a lawyer for the State, Scott Allen, said Wednesday that Eli Lilly systematically hid the risks associated with the popular anti-psychotic Zyprexa. The drug has been linked to an elevated risk of developing diabetes. The state is asking Lilly to pay for the medical expenses of Medicaid patients that developed diabetes and other...

• Flu Meds Tied to Neuropsychiatric Events

  Scott Kappes | March 04, 2008 5:23 PM | 0 CommentsHouston, TX

  Millions of people the world over catch the flu each year. Many experience extremely debilitating symptoms from the influenza virus. Drugs like Tamiflu and Relenza have been developed to treat these symptoms and offer those infected some relief from the relentless illness. Recent news however has linked these treatments to neuropsychiatric events in some instances. Post-marketing reports, mostly...

• Heparin Related Deaths Prompt Recall

  Scott Kappes | March 03, 2008 5:05 PM | 0 CommentsHouston, TX

  Thousands of Americans depend on the popular blood thinner Heparin to help them survive, but over the past few weeks the drug has been linked to 21 deaths and hundreds of adverse reactions likely due to contamination during the manufacturing process. Nearly half of all of the raw ingredients used to make Heparin are produced in China. The main active ingredient, which is derived from pig...

• Tysabri Linked to Liver Damage

  Scott Kappes | February 29, 2008 10:18 AM | 0 CommentsHouston, TX

  This week federal health officials updated the prescribing information of Tysabri to warn of a possible link to severe and potentially fatal liver damage. Tysabri, used to treat multiple sclerosis, was recently approved to treat Crohn's disease, but now officials say that a patient can begin to experience liver damage within six days of the first dose of the drug. Tysabri was pulled from the...

• Trasylol Contributed to 1,000 Deaths a Month

  Scott Kappes | February 27, 2008 4:29 PM | 0 CommentsHouston, TX

  A couple of weeks ago the popular news program "60 Minutes" aired a story on Bayer's Trasylol. The broadcast told the tragic story of Joseph Randone and his experiences following heart surgery where Trasylol was used to reduce bleeding during the surgery. Physicians told the Randone family that the risk associated with the surgery was around five percent and that Joe would likely be able to...