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

Total Pseudoephedrine reports: 19.
Pseudoephedrine FDA safety alerts: 2005 .
Reported deaths: 9    Reported hospitalizations: 5.
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Reported Pseudoephedrine Side Effects: mania, insomnia, sudden infant death syndrome, hypertension, dehydration, intestinal atresia, urinary retention, vomiting, pallor, nausea, diarrhoea.
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Pseudoephedrine Side Effects Report #5229523-2
Health Professional from UNITED STATES reported PSEUDOEPHEDRINE problem on Jan 19, 2007. Male patient was diagnosed with nasal congestion and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: encephalopathy, tibia fracture. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with DOXYLAMINE, ACETAMINOPHEN. Patient died.

Pseudoephedrine Side Effects Report #5229538-4
PSEUDOEPHEDRINE problem was reported by a Health Professional from UNITED STATES on Jan 19, 2007. Female patient was diagnosed with nasal congestion and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: bronchopneumonia, empyema. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, PARACETAMOL, CARBINOXAMINE MALEATE. Patient died.

Pseudoephedrine Side Effects Report #5229589-X
Health Professional from UNITED STATES reported PSEUDOEPHEDRINE problem on Jan 19, 2007. Male patient was diagnosed with cough and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with PARACETAMOL, CARBINOXAMINE MALEATE. Patient was hospitalized. Patient died.

Pseudoephedrine Side Effects Report #5266137-2
PSEUDOEPHEDRINE problem was reported by a Health Professional from POLAND on Feb 19, 2007. Female patient was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, headache. PSEUDOEPHEDRINE dosage: unknown. Patient recovered.

Pseudoephedrine Side Effects Report #5285846-2
Physician from UNITED STATES reported PSEUDOEPHEDRINE problem on Mar 19, 2007. Female patient was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: angiopathy, congenital anomaly, dysmorphism. PSEUDOEPHEDRINE dosage: unknown. Patient recovered.

Pseudoephedrine Side Effects Report #5314745-2
PSEUDOEPHEDRINE problem was reported by a Consumer or non-health professional from BELGIUM on Apr 12, 2007. Female patient, 56 years of age, was diagnosed with rhinitis allergic and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: blood sodium decreased, hypertension, insomnia, mania, sinusitis, somnolence. PSEUDOEPHEDRINE dosage: unknown. Patient was hospitalized. Patient recovered.

Pseudoephedrine Side Effects Report #5330398-1
Consumer or non-health professional from reported PSEUDOEPHEDRINE problem on May 18, 2007. Female patient, 56 years of age, was diagnosed with rhinitis allergic and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: energy increased, euphoric mood, flight of ideas, hypertension, insomnia, logorrhoea, mania, self esteem inflated. PSEUDOEPHEDRINE dosage: unknown. Patient was hospitalized. Patient recovered.

Pseudoephedrine Side Effects Report #5352309-5
PSEUDOEPHEDRINE problem was reported by a Consumer or non-health professional from UNITED STATES on June 07, 2007. Male patient, 67 years of age, weighting 190.0 lb, was diagnosed with asthma, hypersensitivity and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: dysuria, heart rate increased, insomnia, visual disturbance. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with PSEUDOEPHEDRINE AND TRIPROLIDINE. Patient recovered.

Pseudoephedrine Side Effects Report #5108859-X
Pharmacist from UNITED STATES reported PSEUDOEPHEDRINE problem on Sept 15, 2006. Female patient, 73 years of age, weighting 178.0 lb, was diagnosed with cough and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: dizziness, palpitations. PSEUDOEPHEDRINE dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Pseudoephedrine Side Effects Report #5119076-1
PSEUDOEPHEDRINE problem was reported by a Physician from UNITED STATES on Sept 15, 2006. Male patient, 18 years of age, was diagnosed with suicide attempt and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, apnoea, aspartate aminotransferase increased, blood creatine increased, blood creatine phosphokinase increased, blood methaemoglobin present, blood ph decreased, blood potassium increased, body temperature increased. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with IBUPROFEN, ASPIRIN, PARACETAMOL, NAPROXEN, ESCITALOPRAM OXALATE, CYCLOBENZAPRINE HYDROCHLORIDE. Patient died.

Pseudoephedrine Side Effects Report #5160480-3
Consumer or non-health professional from UNITED STATES reported PSEUDOEPHEDRINE problem on Nov 01, 2006. Female patient, 18 years of age, was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: overdose. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with ESCITALOPRAM OXALATE. Patient died.

Pseudoephedrine Side Effects Report #5165478-7
PSEUDOEPHEDRINE problem was reported by a Physician from UNITED STATES on Dec 06, 2006. Male patient, weighting 14.99 lb, was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, staphylococcal infection. PSEUDOEPHEDRINE dosage: unknown. Patient died on 09/17/2005.

Pseudoephedrine Side Effects Report #5165484-2
Physician from UNITED STATES reported PSEUDOEPHEDRINE problem on Dec 06, 2006. Male patient, weighting 8.00 lb, was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: anoxic encephalopathy, lower limb fracture. PSEUDOEPHEDRINE dosage: unknown. Patient died on 06/23/2005.

Pseudoephedrine Side Effects Report #5165485-4
PSEUDOEPHEDRINE problem was reported by a Physician from UNITED STATES on Dec 06, 2006. Male patient, weighting 15.00 lb, was treated with PSEUDOEPHEDRINE. PSEUDOEPHEDRINE dosage: unknown. Patient died on 12/27/2005.

Pseudoephedrine Side Effects Report #5189921-2
Health Professional from FRANCE reported PSEUDOEPHEDRINE problem on Dec 08, 2006. Female patient, 17 years of age, was diagnosed with intentional overdose and was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: asthenia, diarrhoea, nausea, pallor, vomiting. PSEUDOEPHEDRINE dosage: 900 MG - 15 TABLETS ONCE (1 IN 1 D), ORAL. During the same period patient was treated with IBUPROFEN, XANAX, ACETAMINOPHEN, SAVARINE, RODOGYL, VOLTAREN, ACECLOFENAC. Patient was hospitalized. Patient recovered.

Pseudoephedrine Side Effects Report #5394928-6
PSEUDOEPHEDRINE problem was reported by a Health Professional from UNITED KINGDOM on July 11, 2007. Male patient, 53 years of age, weighting 220.5 lb, was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: urinary retention. PSEUDOEPHEDRINE dosage: 120MG, ORAL. Patient recovered.

Pseudoephedrine Side Effects Report #5407971-5
Health Professional from UNITED STATES reported PSEUDOEPHEDRINE problem on July 25, 2007. Female patient was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: intestinal atresia. PSEUDOEPHEDRINE dosage: unknown. Patient recovered.

Pseudoephedrine Side Effects Report #5465595-8
PSEUDOEPHEDRINE problem was reported by a Health Professional from BELGIUM on Sept 12, 2007. Female patient, 56 years of age, was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: mania. PSEUDOEPHEDRINE dosage: unknown. Patient recovered.

Pseudoephedrine Side Effects Report #5467879-6
Physician from UNITED STATES reported PSEUDOEPHEDRINE problem on Sept 12, 2007. Male patient, weighting 20.50 lb, was treated with PSEUDOEPHEDRINE. After drug was administered, patient experienced the following problems/side effects: dehydration. PSEUDOEPHEDRINE dosage: unknown. During the same period patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PHENYLPROPANOLAMINE, ACETAMINOPHEN, TRIMETHOPRIM, LIDOCAINE, CHLORPHENIRAMINE. Patient died on 03/20/1999.


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encephalopathy, tibia fracture bronchopneumonia, empyema interstitial lung disease blood pressure increased, headache, was diagnosed with nasal congestion and was diagnosed with nasal congestion and was diagnosed with cough and