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Voltaren Gel (diclofenac sodium topical gel) 1% – Hepatic Effects Labeling Changes

Audience: Rheumatological healthcare professionals, pharmacists
[Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and…


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December 7th, 2009

Lexiva (fosamprenavir calcium) – Dear Healthcare Professional Letter

Audience: HIV/Infectious Disease healthcare professionals, cardiovascular healthcare professionals
GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in…


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December 3rd, 2009

Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects

Audience: Neurological and Obstetrical healthcare professionals
The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular…


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December 3rd, 2009

Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects

Audience: Neurological and Obstetrical healthcare professionals
The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular…


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December 3rd, 2009

Lexiva (fosamprenavir calcium) – Dear Healthcare Professional Letter

Audience: HIV/Infectious Disease healthcare professionals, cardiovascular healthcare professionals
GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in…


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December 3rd, 2009

Norpramin (desipramine hydrochloride) – Dear Healthcare Professional Letter

Audience: Psychiatric healthcare professionals
Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the…


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December 3rd, 2009

Norpramin (desipramine hydrochloride) – Dear Healthcare Professional Letter

Audience: Psychiatric healthcare professionals
Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the…


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December 3rd, 2009

Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review

Audience: Cardiology and endocrinology healthcare professionals
FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of…


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November 23rd, 2009

Vicks Sinex Nasal Spray – Recall

Audience: Consumers
Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of…


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November 20th, 2009

RockHard Weekend – product contains undeclared drug ingredient

Audience: Consumers, pharmacists
[Posted 11/18/2009] RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an…


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November 19th, 2009

RockHard Weekend – product contains undeclared drug ingredient

Audience: Consumers, pharmacists
[Posted 11/18/2009] RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an…


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November 19th, 2009

IDS Sports Dietary Supplements – Recall

Audience: Consumers
IDS Sports and FDA notified consumers that five of the IDS’s dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA…


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November 19th, 2009

IDS Sports Dietary Supplements – Recall

Audience: Consumers
IDS Sports and FDA notified consumers that five of the IDS’s dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA…


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November 19th, 2009

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) – Drug Interaction

Audience: Cardiovascular healthcare professionals, pharmacists
FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec…


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November 19th, 2009

Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) – Drug Interaction

Audience: Cardiovascular healthcare professionals, pharmacists
FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec…


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November 19th, 2009
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