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Monthly Archives: September 2011
Qualitest Pharmaceuticals Oral Contraceptives Recall
Translation Qualitest Pharmaceuticals Oral Contraceptives: Recall – Packaging Error includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, Tri-Previfem AUDIENCE: Consumer, Pharmacy, OB/GYN ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots … Continue reading
Posted in Consumer Products, FDA 2011, FDA Recall, OBGYN, Pharmacy
Tagged Cyclafem 1/35, Cyclafem 7/7/7, Emoquette, FDA recall, Gildess FE 1.5/30, Gildess FE 1/20, OBGYN, Oral Contraceptives, Orsythia, Previfem, Qualitest Pharmaceuticals, Tri-Previfem
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Zofran (ondansetron) Drug Safety Communication
TranslationZofran (ondansetron): Drug Safety Communication – Risk of Abnormal Heart Rhythms AUDIENCE: Oncology, Anesthesiology ISSUE: FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics). Ondansetron … Continue reading
Posted in Anesthesiology, FDA 2011, FDA Label Change, FDA Warning, Oncology
Tagged drug risks, Drug Safety Communication, FDA notice, FDA warning, safety label changes, Zofran (ondansetron)
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Tumor Necrosis Factor-alpha (TNFα) Blockers Label Change
TranslationTumor Necrosis Factor-alpha (TNFα) Blockers: Label Change – Boxed Warning Updated for Risk of Infection from Legionella and Listeria including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) AUDIENCE: Rheumatology, Gastroenterology, Oncology ISSUE: FDA notified healthcare … Continue reading
Posted in FDA 2011, FDA Label Change, Gastroenterology, Oncology, Rheumatology
Tagged Cimzia (certolizumab pegol), Enbrel (etanercept), Gastroenterology, Humira (adalimumab), Oncology, Remicade (infliximab), Rheumatology, Simponi (golimumab)
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August 2011 Safety Labeling Changes
TranslationAugust 2011 Safety Labeling Changes: 44 Medical Product Labels with changes to Prescribing Information The MedWatch August 2011 Safety Labeling Changes posting includes 45 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, … Continue reading
Posted in Consumer Products, FDA 2011, FDA Label Change
Tagged Accolate (zafirlukast) tablets, Actos (pioglitazone hydrochloride) Tablets, and Lamictal XR Extended-Release Tablets, and Oral Solution, August 2011 Safety Labeling Changes, Bentyl (dicyclomine hydrochloride, Betapace and Betapace AF (sotalol HCl) Tablets, BiCNU (carmustine for injection), Celexa (citalopram hydrobromide) Tablets and Oral Solution, Chewable D, DepoCyt (cytarabine liposome injection), Ditropan (Oxybutynin chloride) Tablets, Dostinex (cabergoline) Tablets, Exjade (deferasirox) Tablets for Oral Suspension, Haldol (haloperidol) Injection and Haldol Decanoate (haloperidol) IM Injection, Hyzaar (losartan/hydrochlorothiazide) Tablets, ispersible Tablets Lamictal Orally Disintegrating Tablets, Kerledex (betaxolol hydrochloride/chlorthalidone) Tablets, Kerlone (betaxolol hydrochloride) Tablets, Lamictal (lamotrigine) Tablets, Mobic (meloxicam) Tablets and Oral Suspension, Multaq (dronedarone hydrochloride) Tablets, Neurontin (gabapentin) Capsules, Oral Syrup and Injection, Platinol (cisplatin for injection, Prinzide (lisinopril/hydrochlorothiazide) Tablets, Reclast (zoledronic acid) Injection, Saphris (asenapine) Sublingual Tablets, Sensipar (cinacalcet) Tablets, tablets, Tenoretic (atenolol/chlorthalidone) Tablets, Tenormin (atenolol) Tablets, Thallous Chloride [Tl-201] Injection, USP), USP) Capsules/Tablets, Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate
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Saphris asenapine maleate
TranslationSaphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions AUDIENCE: Psychiatry, Patients ISSUE: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, … Continue reading
Posted in FDA 2011, FDA Label Change, Psychiatry
Tagged asenapine maleate, drug risks, Drug Safety Communication, FDA notice, FDA warning, safety label changes, Saphris
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Reclast zoledronic acid
TranslationReclast (zoledronic acid): Drug Safety Communication – New Contraindication and Updated Warning on Kidney Impairment AUDIENCE: Endocrinology, Pharmacy, Patient ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk … Continue reading
Posted in Endocrinology, FDA 2011, Pharmacy
Tagged Drug Safety Communication, Endocrinology, FDA notice, FDA warning, Patient, Pharmacy
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