FDA & Prescription Drugs | InjuryBoard Galveston Bay

Today Actavis South Atlantic LLC announced the recall of several lots of fentanyl pain patches. This is the second recall of fentanyl pain patches in one week's time. Last week Johnson & Johnson issued a recall of specific lots of 25 microgram per hour Duragesic pain patches, for a risk that the some patches may have a defect that allows the medication to be releases faster than intended,...

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A former clinical research associate who worked on the clinical trials for the antibiotic, Ketek, said that researchers and Sanofi-Aventis worked together to defraud the FDA. Ketek has been linked to liver problems and according to allegations by the FDA the manufacturer, Sanofi-Aventis, made deliberate efforts to conceal evidence that would be harmful to the drug during the post marketing...

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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...

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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...

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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...

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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,...

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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...

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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...

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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...

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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...

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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...

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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...

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A new rule being proposed by the FDA would be welcomed by drug companies and could be a thorn in the side of plaintiffs' lawyers everywhere. The new rule would establish narrow guidelines under which drug companies can make changes to drug labels on their own. It may seem somewhat odd that drug companies would approve a narrowing of guidelines by the FDA, but it makes perfect sense when...

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A study released yesterday shows evidence that the blockbuster cholesterol medication Vytorin is not anymore effective than generic Zocor. Vytorin, a combination of Zetia and Zocor, is prescribed over 100,000 times each day generating over $5 billion in annual sales for Merck and Schering-Plough. Vytorin was shown to lower bad cholesterol levels better than Zocor alone, but showed no measurable...

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On Wednesday the FDA sent letters to seven pharmacies ordering them to stop making false and misleading claims about custom-made "compounded" hormone products sold over the Internet to treat menopause. Claims that these synthesized hormones are more effective than approved menopause therapies are false according to the FDA and other experts. The FDA said in the letters that the claims made by...

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