All Posts Tagged With: "adverse reactions"

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Hazardous Levels of Selenium in “Total Body Formula” and”Total Body Mega Formula”

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.
On March 27, [...]

Popularity: 82% [?]

10Apr2008 | PharmaWatchDog | 0 comments | Continued
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Dietary Supplement Associated with Severe Adverse Reactions

The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 [...]

Popularity: 60% [?]

28Mar2008 | PharmaWatchDog | 0 comments | Continued
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Chantix Label Revision

FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of [...]

Popularity: 50% [?]

27Feb2008 | PharmaWatchDog | 0 comments | Continued
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Leukine (sargramostim)

Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally [...]

Popularity: 48% [?]

27Feb2008 | PharmaWatchDog | 0 comments | Continued
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Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum [...]

Popularity: 49% [?]

9Feb2008 | PharmaWatchDog | 0 comments | Continued
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More on Chantix

Many new drugs initially enjoy banner sales growth, only to get kneecapped by reports of previously unknown adverse side effects. On Friday, the FDA issued an alert “highlighting” a stricter warning label for one of Pfizer’s most important new drugs.
The compound in question, Chantix, is one of the most recent non-nicotine stop-smoking treatments on the [...]

Popularity: 46% [?]

5Feb2008 | PharmaWatchDog | 0 comments | Continued
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Leukine (sargramostim)

Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally [...]

Popularity: 35% [?]

28Jan2008 | PharmaWatchDog | 0 comments | Continued
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