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, said the Institute of Medicine report, released yesterday.
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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Vivelle Safety Reports submitted to FDA

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Total Vivelle reports: 46.
Vivelle FDA safety alerts: No.
   Reported hospitalizations: 8.
Take Vivelle Side Effects Survey or Share Your Vivelle Story.
Reported Vivelle Side Effects: biopsy breast abnormal, breast cancer female, breast cancer in situ, pulmonary embolism, breast cancer stage iv, dyspnoea, headache, back pain, anxiety, visual disturbance, dizziness.
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Vivelle Side Effects Report #5228557-1
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Jan 23, 2007. Female patient, 50 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: anxiety, back pain, blood pressure increased, dizziness, erythema, fall, feeling hot and cold, hormone level abnormal, insomnia. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5228559-5
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 24, 2007. Female patient, 51 years of age, was diagnosed with menopausal symptoms and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: foot operation, headache. VIVELLE dosage: 0.0375 MG/DY, TWICE WEEKLY. Patient recovered.

Vivelle Side Effects Report #5240352-6
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Feb 06, 2007. Female patient, 50 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: cluster headache, feeling hot, hyperthyroidism, insomnia, palpitations, tremor. VIVELLE dosage: 0.05 MG/DAY, TWICE WEEKLY. During the same period patient was treated with SYNTHROID. Patient recovered.

Vivelle Side Effects Report #5243581-0
VIVELLE problem was reported by a Health Professional from UNITED STATES on Feb 20, 2007. Female patient, 53 years of age, weighting 129.0 lb, was diagnosed with menopause and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast tenderness, dizziness, headache, incorrect dose administered, nausea, speech disorder, thinking abnormal. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5250760-5
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Feb 19, 2007. Female patient, 51 years of age, weighting 195.0 lb, was diagnosed with sleep disorder and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: abscess, anxiety, breast abscess, breast cancer in situ, breast cyst, breast microcalcification, breast tenderness, dysphonia, dyspnoea. VIVELLE dosage: 0.025 MG/DAY, Q3 DAYS. During the same period patient was treated with PREMARIN, ALORA, CLIMARA, BELLERGAL. Patient recovered.

Vivelle Side Effects Report #5252924-3
VIVELLE problem was reported by a Physician from UNITED STATES on Feb 22, 2007. Female patient, 67 years of age, weighting 212.0 lb, was diagnosed with menopausal symptoms, arthritis and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alopecia, blood cholesterol increased, cholecystectomy, cholelithiasis, fluid retention, hypothyroidism, hypotrichosis. VIVELLE dosage: 0.05 MG/DAY, BIW. During the same period patient was treated with PLAQUENIL, VITAMINS. Patient recovered.

Vivelle Side Effects Report #5258458-4
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Feb 26, 2007. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: anxiety, arrhythmia, breast cancer in situ, chest pain, electrocardiogram ambulatory abnormal, emotional distress, injury, intervertebral disc protrusion, laboratory test abnormal. VIVELLE dosage: 0.05 MG/DAY, UNK. During the same period patient was treated with PREMARIN, CLIMARA, ESTRACE. Patient recovered.

Vivelle Side Effects Report #5265904-9
VIVELLE problem was reported by a Physician from UNITED STATES on Mar 05, 2007. Female patient, 58 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: arthralgia, atrial fibrillation, atrial flutter, atrial hypertrophy, back pain, biopsy breast abnormal, breast cancer female, breast cancer stage iv, breast hyperplasia. VIVELLE dosage: unknown. During the same period patient was treated with PREMARIN, PROVERA, CYCRIN, CURRETAB, ESTRACE, ESTRATEST, PREMPRO. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5265909-8
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Mar 05, 2007. Female patient, 56 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: aspiration breast, benign lung neoplasm, biopsy breast abnormal, biopsy mucosa abnormal, breast cancer, breast cancer female, breast discomfort, cervical stricture, colitis. VIVELLE dosage: 0.0375 MG/DAY. During the same period patient was treated with PREMPHASE, PROVERA, MEDROXYPROGESTERONE. Patient recovered.

Vivelle Side Effects Report #5276064-2
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Female patient, 43 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: abdominoplasty, back pain, breast cosmetic surgery, dyspnoea, pulmonary embolism. VIVELLE dosage: 0.1MG TWICE WEEKLY. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5278793-3
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Mar 19, 2007. Female patient, 61 years of age, weighting 198.0 lb, was diagnosed with night sweats, amnesia, affective disorder and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: biopsy breast abnormal, breast cancer, breast mass, depression, haemangioma of liver, knee arthroplasty, limb discomfort, lung infiltration, lymphadenectomy. VIVELLE dosage: unknown. During the same period patient was treated with ESTRACE, ESTRATAB, ESTROPIPATE, PREMPRO, PREMARIN, PROVERA, FISH OIL. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5281626-2
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 19, 2007. Female patient, 60 years of age, weighting 180.0 lb, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: adenocarcinoma, arthroscopy, biopsy breast abnormal, breast cancer, breast hyperplasia, breast mass, depression, hot flush. VIVELLE dosage: 0.1 MG/DAY, UNK. During the same period patient was treated with ESTRACE, PROVERA, CYCRIN, PREMPRO, PREMARIN. Patient recovered.

Vivelle Side Effects Report #5284700-X
Physician from UNITED STATES reported VIVELLE problem on Nov 29, 2005. Female patient, 50 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased. VIVELLE dosage: 0.025 MG/DAY, 2X WEEK, TRANSDERMAL. During the same period patient was treated with ATENOLOL. Patient recovered.

Vivelle Side Effects Report #5284702-3
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2006. Female patient, 62 years of age, was diagnosed with menopausal symptoms and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cancer in situ, mastectomy. VIVELLE dosage: unknown. During the same period patient was treated with PREMARIN, PROVERA, MEDROXYPROGESTERONE. Patient recovered.

Vivelle Side Effects Report #5284718-7
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on July 07, 2006. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cancer. VIVELLE dosage: unknown. During the same period patient was treated with ESTRADERM, PROVERA, PREMPRO, PREMARIN, ESTRATES, MEDROXYPROGESTERONE. Patient recovered.

Vivelle Side Effects Report #5284728-X
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 08, 2006. Female patient, 58 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cancer. VIVELLE dosage: unknown. During the same period patient was treated with PREMARIN. Patient recovered.

Vivelle Side Effects Report #5339086-9
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Nov 21, 2006. Female patient, 54 years of age, was diagnosed with menopause and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: anxiety, application site erythema, cold sweat, dysphonia, eye irritation, fatigue, headache, hot flush, malaise. VIVELLE dosage: unknown. During the same period patient was treated with PREMARIN. Patient recovered.

Vivelle Side Effects Report #5339087-0
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on May 05, 2006. Female patient, 59 years of age, weighting 175.9 lb, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cancer in situ. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5339088-2
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Feb 27, 2006. Male patient, 81 years of age, was diagnosed with prostate cancer and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: brain scan abnormal, cerebrovascular accident, prescribed overdose, prostatic specific antigen increased, visual disturbance. VIVELLE dosage: unknown. During the same period patient was treated with KETOCONAZOLE, ESTRADIOL, AVODART, LEUKINE. Patient recovered.

Vivelle Side Effects Report #5339089-4
VIVELLE problem was reported by a Health Professional from UNITED STATES on Mar 17, 2006. Female patient, 60 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cancer. VIVELLE dosage: 0.5 MG, 2X WEEK, TRANSDERMAL. Patient recovered.

Vivelle Side Effects Report #5339096-1
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Mar 21, 2006. Female patient, 60 years of age, was diagnosed with menopausal symptoms and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cancer. VIVELLE dosage: unknown. During the same period patient was treated with PREMARIN, PROVERA. Patient recovered.

Vivelle Side Effects Report #5339097-3
VIVELLE problem was reported by a Health Professional from UNITED STATES on May 15, 2006. Female patient, 42 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased. VIVELLE dosage: 0.05 MG TWICE WEEKLY. Patient recovered.

Vivelle Side Effects Report #5339098-5
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on June 07, 2006. Female patient, 52 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: dizziness, dyspnoea, headache, hot flush, hypertension, tinnitus. VIVELLE dosage: unknown. During the same period patient was treated with THYROID. Patient recovered.

Vivelle Side Effects Report #5339099-7
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 14, 2006. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: asthma, laryngitis. VIVELLE dosage: 0.5 MG. Patient recovered.

Vivelle Side Effects Report #5339100-0
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Dec 11, 2006. Female patient, 63 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: blood triglycerides increased. VIVELLE dosage: 0.05 MG/DAY, TWICE DAILY, TRANSDERMAL. Patient recovered.

Vivelle Side Effects Report #5339101-2
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 12, 2006. Female patient, 59 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: breast cyst, depressed mood, nervousness. VIVELLE dosage: 0.075 MG/DAY, WEEKLY, TRANSDERMAL. Patient recovered.

Vivelle Side Effects Report #5339103-6
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Jan 30, 2007. Female patient, 70 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: dementia, headache, hypertension, muscle spasms, nausea, nervousness. VIVELLE dosage: 0.075 MG/DAY, TRANSDERMAL. Patient recovered.

Vivelle Side Effects Report #5374325-X
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on June 20, 2007. Female patient, 62 years of age, weighting 145.0 lb, was diagnosed with menopausal symptoms, hot flush, depression and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: arthritis, breast cancer in situ, breast infection, breast reconstruction, device breakage, dyspnoea, fatigue, foot operation, hypersensitivity. VIVELLE dosage: 0.05 MG, UNK. During the same period patient was treated with PREMARIN, PROVERA, PREMPRO, LEXAPRO, CELEBREX. Patient recovered.

Vivelle Side Effects Report #5047770-X
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on July 01, 2006. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: bladder mass, computerised tomogram abnormal. VIVELLE dosage: 0.0375 MG/DAY, BIW. Patient recovered.

Vivelle Side Effects Report #5055952-6
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on July 01, 2006. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: computerised tomogram abnormal, scar. VIVELLE dosage: 0.0375 MG/DAY, BIW. Patient recovered.

Vivelle Side Effects Report #5113970-3
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Sept 19, 2006. Female patient, 49 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: eye disorder, eye operation, retinal detachment, visual disturbance. VIVELLE dosage: 0.05 MG/DAY, TWICE WEEKLY. Patient recovered.

Vivelle Side Effects Report #5125666-2
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 10, 2006. Female patient, 44 years of age, weighting 211.0 lb, was diagnosed with hot flush and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: gallbladder obstruction, gastrointestinal disorder, liver disorder, pancreatic carcinoma, pulmonary embolism. VIVELLE dosage: unknown. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5129824-2
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on June 03, 2006. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: gallbladder obstruction, liver disorder, pancreatic carcinoma, pulmonary embolism, small intestine carcinoma, surgery. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5136515-0
VIVELLE problem was reported by a Physician from UNITED STATES on Oct 18, 2006. Female patient, 49 years of age, weighting 176.4 lb, was diagnosed with night sweats, atrophic vulvovaginitis, insulin-requiring type ii diabetes mellitus, gastrooesophageal reflux disease, herpes virus infection, hypertension and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, blood pressure increased, cluster headache, dizziness, hypertension, hypotension, nausea. VIVELLE dosage: unknown. During the same period patient was treated with VAGIFEM, NOVOLOG, PREVACID, VALTREX, DIOVAN, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5140080-1
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on June 03, 2006. Female patient was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: gallbladder obstruction, liver disorder, pancreatic carcinoma metastatic, pulmonary embolism, small intestine carcinoma, surgery. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5150535-1
VIVELLE problem was reported by a Pharmacist from UNITED STATES on Nov 10, 2006. Female patient, 59 years of age, weighting 152.0 lb, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: rash. VIVELLE dosage: 0.05 MG BIWEEKLY TRANSDERMAL. Patient recovered.

Vivelle Side Effects Report #5155279-8
Pharmacist from UNITED STATES reported VIVELLE problem on Nov 13, 2006. Female patient, 40 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: paraesthesia, vision blurred. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5162356-4
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 19, 2006. Female patient, 49 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: cataract, eye disorder, eye operation, retinal detachment, visual disturbance. VIVELLE dosage: 0.05 MG/DAY, TWICE WEEKLY. Patient recovered.

Vivelle Side Effects Report #5163558-3
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Nov 20, 2006. Female patient, 43 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: abdominoplasty, back pain, breast cosmetic surgery, dyspnoea, pulmonary embolism. VIVELLE dosage: 0.1MG TWICE WEEKLY. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5175869-6
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 19, 2006. Female patient, 49 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: cataract, eye disorder, eye operation, retinal detachment, visual disturbance. VIVELLE dosage: 0.05 MG/DAY, TWICE WEEKLY. Patient recovered.

Vivelle Side Effects Report #5185318-X
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on Dec 11, 2006. Female patient, 47 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: application site erythema, application site pruritus, application site reaction, haematoma, lower respiratory tract infection, pain, wound drainage. VIVELLE dosage: 0.1 MG/DAY, TWICE WEEKLY. Patient recovered.

Vivelle Side Effects Report #5188049-5
VIVELLE problem was reported by a Pharmacist from UNITED STATES on Nov 13, 2006. Female patient, 40 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: paraesthesia, vision blurred. VIVELLE dosage: unknown. Patient recovered.

Vivelle Side Effects Report #5389872-4
Consumer or non-health professional from UNITED STATES reported VIVELLE problem on July 06, 2007. Female patient, 56 years of age, was diagnosed with menopause and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: accident, back pain, biopsy breast abnormal, biopsy endometrium abnormal, bladder disorder, breast cancer, breast microcalcification, cystocele. VIVELLE dosage: 0.05 MG/DAY, UNK. During the same period patient was treated with PREMARIN, PROVERA, ESTRACE, PROMETRIUM. Patient recovered.

Vivelle Side Effects Report #5404800-0
VIVELLE problem was reported by a Consumer or non-health professional from UNITED STATES on July 27, 2007. Female patient, 55 years of age, weighting 155.0 lb, was diagnosed with menopause, menopausal symptoms, hypertension, haemorrhage and was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: anaemia, anxiety, atrial fibrillation, biopsy breast, biopsy breast abnormal, breast cancer, breast cellulitis, breast disorder female, breast mass. VIVELLE dosage: 0.05 MG, UNK. During the same period patient was treated with ESTRADERM, CARDIZEM, COZAAR, PRILOSEC, DIGOXIN, CLIMARA, PROVERA, PREMPRO. Patient recovered.

Vivelle Side Effects Report #5411775-7
Health Professional from UNITED STATES reported VIVELLE problem on Aug 06, 2007. Female patient, 52 years of age, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: blood cholesterol abnormal, cerebrovascular accident, hyperlipidaemia, hypoaesthesia, overweight. VIVELLE dosage: unknown. During the same period patient was treated with PROMETRIUM. Patient was hospitalized. Patient recovered.

Vivelle Side Effects Report #5428783-2
VIVELLE problem was reported by a Health Professional from UNITED STATES on Aug 21, 2007. Female patient, 52 years of age, weighting 210.0 lb, was treated with VIVELLE. After drug was administered, patient experienced the following problems/side effects: blood cholesterol abnormal, blood cholesterol increased, blood triglycerides increased, cerebrovascular accident, hyperlipidaemia, hypoaesthesia, low density lipoprotein increased, overweight, speech disorder. VIVELLE dosage: 0.075 MG/DAY, TWICE WEEKLY. During the same period patient was treated with PROMETRIUM, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

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