FDA & Prescription Drugs

• Writer Gives First-Hand Account of Chantix Experiences

  Scott Kappes | February 13, 2008 4:19 PM | 0 CommentsGalveston Bay, TX

  A writer for New York Magazine recently published an article entitled, "My Brain on Chantix," revealing his personal experiences while taking Chantix. Derek de Koff says in the article that he never believed the stories of Chantix contributing to the tragic shooting death of Carter Albrecht, that is until he began taking the drug himself. Chantix has been hailed by many as a "miracle drug," but...

• FDA Warns of Child Deaths Resulting From Botox

  Scott Kappes | February 08, 2008 4:18 PM | 0 CommentsGalveston Bay, TX

  Today the FDA issued an Early Communication about an ongoing study on the use of Botox. The communication was issued in response to a small amount of deaths and other severe side effects suggestive of botulism associated with the drug. Botox is commonly used to block nerve impulses allowing muscles to relax, therefore eliminating involuntary twitches and spasms. In recent years Botox has been...

• FDA Panel To Vote On Zyprexa

  Scott Kappes | February 06, 2008 4:03 PM | 0 CommentsGalveston Bay, TX

  Today a panel of outside experts will examine advise the FDA on whether or not a new injectable version of the popular schizophrenia drug, Zyprexa, should be approved in the US. Zyprexa is currently available in a once-daily pill form, but the new formula, Zyprexa Adhera, can be injected into the muscle and last up to four weeks. The panel will weigh all aspects of the drug and available...

• Chantix: FDA Warns of Neuropsychiatric Symptoms

  Scott Kappes | February 06, 2008 9:56 AM | 0 CommentsGalveston Bay, TX

  On Friday the FDA issue a Public Health Advisory for Pfizer's popular smoking cessation drug Chantix. This advisory comes just two months after an Early Communication advised physicians of a possible link between Chantix and neuropsychiatric symptoms. The FDA has now said that it is becoming increasingly likely that this association exists. The shooting death of Dallas musician Carter Albrecht,...

• Epilepsy Drugs Double the Risk of Suicidal Thought

  Scott Kappes | February 01, 2008 11:46 AM | 0 CommentsGalveston Bay, TX

  Yesterday the FDA announced the findings of a two-year study on medications used to treat epilepsy and bi-polar disorder. The combined analysis of almost 44,000 patients in 199 clinical trials found that the drugs tested were twice as likely to produce suicidal thoughts in patients, when compared to those treated with a placebo. The study found 4 suicides and 105 reports of suicidal ideation...

• FEMA Accused of Manipulating Research on Trailers

  Scott Kappes | January 29, 2008 4:27 PM | 0 CommentsGalveston Bay, TX

  Yesterday a House subcommittee made allegations that FEMA employees manipulated scientific data in order to hide the dangers of toxic gas emitted into trailers housing survivors of hurricanes Katrina and Rita. The committee cited documents given to Congress alleging that Centers for Disease Control and Prevention (CDC) aided FEMA is concealing adverse health effects of long-term exposure to...

• Another Psychotic Episode Linked To Chantix?

  Scott Kappes | January 25, 2008 10:58 AM | 0 CommentsGalveston Bay, TX

  I came across another frightening claim of psychotic behavior that appears could be linked to Pfizer's stop smoking drug Chantix. The story comes out of the UK where the drug is marketed as Champix. A woman living in the UK claims that on Christmas Eve her boyfriend who had been taking Champix for several months went what she described as "berserk." The woman claims that her boyfriend had been...

• Antidepressants: The Untold Story

  Scott Kappes | January 22, 2008 4:33 PM | 0 CommentsGalveston Bay, TX

  Last week the New England Journal of Medicine published an article claiming that the positive effect of antidepressants have been skewed way out of proportion by the lack of published reports that detail negative findings. After reviewing studies submitted to the FDA for 12 different antidepressants a report concluded that 88 per cent of studies that showed negative results were never published...

• Ortho Evra Gets Additional Warnings

  Scott Kappes | January 21, 2008 4:53 PM | 0 CommentsGalveston Bay, TX

  Last Friday the FDA approved additional changes to the label of the once blockbuster Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary...

• Chantix Gets New Warning For Behavioral Changes

  Scott Kappes | January 18, 2008 1:46 PM | 0 CommentsGalveston Bay, TX

  Today Pfizer announced that the smoking cessation drug Chantix will now carry an additional warning advising doctors to monitor patients for changes in behavior, including but not limited to depressed mood, agitation, suicidal thoughts and suicidal behavior. While no causal relationship has been established between these changes and Chantix; however, Pfizer said a possible link couldn't be ruled...