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2006 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements
How to Find a Safety Summary
Click on one of the five categories below, then click on a product to go to the safety summary.
Biologics - Special Nutritional Products and Cosmetics - Drugs and Therapeutic Biologics - Medical Devices
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Biologics (CBER):
Human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) (Posted 03/02/2006)
WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]) (Posted 01/06/2006)
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Special Nutritional Products and Cosmetics:
Anabolic Xtreme Superdrol (Posted 03/10/2006)
Brazilian Diet Pills (Emagrece Sim and Herbathin products) (Posted 01/13/2006)
Mead Johnson GENTLEASE powdered infant formula (Posted 02/22/2006)
Methyl-1-P (Posted 03/10/2006)
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Drugs and Therapeutic Biological Products (CDER):
Anabolic Xtreme Superdrol (Posted 03/10/2006)
Avandamet (rosiglitazone maleate) (Posted 01/05/2006)
Avandia (rosiglitazone maleate/metformin hcl) (Posted 01/05/2006)
Benzocaine sprays (Posted 02/13/2006)
Cefazolin for Injection (Posted 03/01/2006)
Clozaril (clozapine) (Posted 01/13/2006)
Cytosol Laboratories, Inc. Balanced Salt Solution (Posted 02/14/2006)
Diastat AcuDial (diazepam rectal gel) (Posted 03/30/2006)
Droxia (hydroxyurea capsules) (Posted 01/26/2006)
Elidel Cream (pimecrlimus) (posted 01/20/2006)
Fleet Phospho-Soda and Fleet Accu-Prep (Posted 05/05/2006)
Goldline Brand Extra Strength Genapap and Extra Strength Genebs (Posted 05/02/2006)
Hydrea (hydroxyurea capsules) (Posted 01/26/2006)
Illegal Steroid Products Sold as Dietary Supplements (Posted 03/10/2006)
Ketek (telithromycin) (Posted 01/20/2006)
Macugen (pegaptanib sodium injection) (Posted 04/07/2006)
Methyl-1-P (Posted 03/10/2006)
Mifeprex (mifepristone) (Posted 03/17/2006)
NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse (Posted 04/28/2006)
Nimotop (nimodipine) (Posted 02/15/2006)
Ontak (denileukin diftitox) (Posted 03/15/2006)
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (Posted 05/05/2006)
Osmoprep Tablets (Posted 05/05/2006)
Paxil (paroxetine hydrochloride) (Posted 05/12/2006)
Promethazine HCl (marketed as Phenergan and generic products) (Posted 4/25/2006)
Protopic Ointment (tacrolimus) (Posted 01/20/2006)
Tequin (gatifloxacin) (Posted 02/16/2006)
Tracleer (bosentan) (Posted 03/02/2006)
Trasylol (aprotinin) (Posted 02/08/2006)
Visicol Tablets (Posted 05/05/2006)
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Medical Devices:
Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps (Posted 04/28/2006
Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps (Posted 02/02/2006)
Blackstone Medical ICON Modular Fixation System (Posted 4/17/2006)
Boca Medical Ultilet Insulin Syringe 30g 1/2cc (Posted 4/17/2006)
Boston Scientific Flextome Cutting Balloon Systems (Posted 02/02/2006)
Cochlear Implants with a Positioner (Posted 02/02/2006)
Davol/Bard Composix Kugel Mesh Patch (Posted 03/02/2006; UPDATED 03/31/2006)
Disetronic Medical Systems ACCU-CHEK Ultraflex Infusion Sets (Posted 04/04/2006)
Fungal Keratitis Infections Related to Contact Lens Use (Posted 04/11/2006; UPDATED 4/17/2006; UPDATED 05/05/2006; UPDATED 05/15/2006)
Gambro Prisma Continuous Renal Replacement System (UPDATE to August 2005 alert, posted 03/01/2006)
Hospital Bed Entrapments (Posted 03/09/2006)
Roche Diagnostics ACCU-CHEK Aviva Meters (Posted 01/19/2006)
Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit (Posted 01/09/2006)
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent (Posted 4/18/2006)
Ossur Total Knee prosthetic device (Posted 03/31/2006)
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals (Posted 04/25/2006)
Respironics PLV Continuum Ventilator (PLVC I) (Posted 05/05/2006)
The First Years Liquid-Filled Teethers (Posted 01/30/2006; UPDATED 02/10/2006)
Vapotherm 2000i and 2000h Respiratory Gas Humidifier (Posted 01/30/2006)
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2006 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page.
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http://www.fda.gov/MedWatch/getforms.htm
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets
Audience: Neuropsychiatric and other healthcare professionals
[Posted 05/12/2006] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults.
A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.
It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.
[May 2006 - Dear Healthcare Professional letter - GlaxoSmithKline]
[April 2006 - Paxil Label - GlaxoSmithKline]
[April 2006 - Paxil CR Label - GlaxoSmithKline]