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1.5 million people annually are harmed from drug errors.

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From simple mix-ups to fatal overdoses, medication mistakes happen, on average, once a day to every hospital patient, a new report says. Nationwide, at least 1.5 million people annually are harmed from drug errors, more than half of them in nursing homes.
Many Unfavorable Drug Studies Aren’t Published. Nearly a third of antidepressant drug studies are never published in the medical literature, and nearly all of those happen to show that the drug being tests failed to work.
Only Drugs That are Safe Should be put on the Market. Drug developers are just beginning to come to grips with recent FDA oversight reforms and how they will affect drug safety. But, it appears that industry and consumer advocates are not together on how well the overhaul will be able to prevent future drug safety scandals.

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Review Bicalutamide Safety Reports submitted to FDA

Total Bicalutamide reports: 14.
Bicalutamide FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 9.
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FDA Reported Bicalutamide Side Effects: breast cancer male, toxic skin eruption, left ventricular failure, exercise tolerance decreased, dyspnoea, cushing's syndrome, hydronephrosis, haemoglobin decreased, haematuria, deep vein thrombosis, calculus bladder.
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Bicalutamide Side Effects Report #5201965-0
Pharmacist from UNITED STATES reported BICALUTAMIDE problem on Jan 04, 2007. Male patient, 59 years of age, was diagnosed with neoplasm malignant and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain lower, abdominal tenderness, acute myocardial infarction, liver disorder, multi-organ failure. BICALUTAMIDE dosage: 50MG PO DAILY. Patient was hospitalized. Patient died on 03/16/2006.

Bicalutamide Side Effects Report #5315620-X
BICALUTAMIDE problem was reported by a Health Professional from UNITED KINGDOM on Apr 24, 2007. Male patient, 68 years of age, weighting 185.2 lb, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: cardiac failure. BICALUTAMIDE dosage: unknown. During the same period patient was treated with TRIMETHOPRIM, ZOLADEX. Patient was hospitalized. Patient recovered.

Bicalutamide Side Effects Report #5370685-4
Physician from FRANCE reported BICALUTAMIDE problem on June 25, 2007. Male patient, 48 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: arthralgia, hot flush, myalgia. BICALUTAMIDE dosage: unknown. During the same period patient was treated with ELIGARD. Patient recovered.

Bicalutamide Side Effects Report #5051468-1
BICALUTAMIDE problem was reported by a Health Professional from UNITED KINGDOM on July 07, 2006. Male patient, 84 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, exercise tolerance decreased, left ventricular failure. BICALUTAMIDE dosage: unknown. During the same period patient was treated with CYPROTERONE ACETATE, BISOPROLOL FUMARATE, FERROUS SULPHATE, FUROSEMIDE, OLMESARTAN MEDOXOMIL, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.

Bicalutamide Side Effects Report #5089018-6
Health Professional from UNITED KINGDOM reported BICALUTAMIDE problem on July 07, 2006. Male patient, 84 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, exercise tolerance decreased, left ventricular failure. BICALUTAMIDE dosage: unknown. During the same period patient was treated with CYPROTERONE ACETATE, BISOPROLOL FUMARATE, FERROUS SULPHATE, FUROSEMIDE, OLMESARTAN MEDOXOMIL, SPIRONOLACTONE. Patient was hospitalized. Patient recovered.

Bicalutamide Side Effects Report #5108317-2
BICALUTAMIDE problem was reported by a Health Professional from UNITED STATES on Sept 14, 2006. Male patient, 58 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: syncope. BICALUTAMIDE dosage: unknown. During the same period patient was treated with GOSERELIN, SEREVENT, ALBUTEROL SULPHATE AND IPRATROPIUM BROMIDE, FELODIPINE, FERROUS SULPHATE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Bicalutamide Side Effects Report #5116784-3
Consumer or non-health professional from FRANCE reported BICALUTAMIDE problem on Sept 19, 2006. Male patient, 78 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: dermatitis exfoliative, rash, toxic skin eruption. BICALUTAMIDE dosage: unknown. During the same period patient was treated with SOTALOL HYDROCHLORIDE, ELIGARD. Patient was hospitalized. Patient recovered.

Bicalutamide Side Effects Report #5134738-8
BICALUTAMIDE problem was reported by a Health Professional from UNITED KINGDOM on Oct 19, 2006. Male patient, 75 years of age, weighting 162.5 lb, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: renal failure, renal failure acute, rhabdomyolysis. BICALUTAMIDE dosage: unknown. During the same period patient was treated with SIMVASTATIN. Patient recovered.

Bicalutamide Side Effects Report #5143914-X
Health Professional from UNITED KINGDOM reported BICALUTAMIDE problem on Oct 30, 2006. Male patient, 80 years of age, was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: neutropenia, pneumonia. BICALUTAMIDE dosage: unknown. During the same period patient was treated with ATENOLOL, LANSOPRAZOLE, LOSARTAN POSTASSIUM, PREDNISOLONE. Patient was hospitalized and became disabled. Patient recovered.

Bicalutamide Side Effects Report #5195541-6
BICALUTAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 22, 2006. Male patient, 79 years of age, weighting 134.5 lb, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: activated partial thromboplastin time prolonged, alanine aminotransferase increased, aspartate aminotransferase increased, bladder diverticulum, calculus bladder, deep vein thrombosis, haematuria, haemoglobin decreased, hydronephrosis. BICALUTAMIDE dosage: 50 MG DAILY PO. Patient was hospitalized. Patient died on 07/05/2006.

Bicalutamide Side Effects Report #5397934-0
Health Professional from JAPAN reported BICALUTAMIDE problem on July 19, 2007. Male patient, 78 years of age, was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: cushing's syndrome. BICALUTAMIDE dosage: unknown. During the same period patient was treated with LEUPROLIDE ACETATE. Patient recovered.

Bicalutamide Side Effects Report #5456897-X
BICALUTAMIDE problem was reported by a Physician from UNITED STATES on Sept 07, 2007. Male patient, 81 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: breast cancer male. BICALUTAMIDE dosage: unknown. During the same period patient was treated with ELIGARD. Patient recovered.

Bicalutamide Side Effects Report #5464465-9
Physician from UNITED STATES reported BICALUTAMIDE problem on Sept 04, 2007. Male patient, 81 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: breast cancer male. BICALUTAMIDE dosage: unknown. During the same period patient was treated with ELIGARD. Patient recovered.

Bicalutamide Side Effects Report #5467238-6
BICALUTAMIDE problem was reported by a Health Professional from FRANCE on Sept 14, 2007. Male patient, 78 years of age, was diagnosed with prostate cancer and was treated with BICALUTAMIDE. After drug was administered, patient experienced the following problems/side effects: toxic skin eruption. BICALUTAMIDE dosage: unknown. During the same period patient was treated with SOTALOL HYDROCHLORIDE, ELIGARD. Patient was hospitalized. Patient recovered.


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abdominal distension, abdominal pain lower, abdominal tenderness, acute myocardial infarction, liver disorder, multi-organ failure, was diagnosed with neoplasm malignant and was diagnosed with prostate cancer and was diagnosed with prostate cancer and