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Review Naropin Safety Reports submitted to FDA

Total Naropin reports: 29.
Naropin FDA safety alerts: No.
Reported deaths: 3    Reported hospitalizations: 10.
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FDA Reported Naropin Side Effects: sensory disturbance, cauda equina syndrome, anaesthetic complication, deafness neurosensory, muscular weakness, stress cardiomyopathy, delayed recovery from anaesthesia, paraparesis, cardiac arrest, shock, bradycardia.
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Naropin Side Effects Report #5647410-2
Health Professional from AUSTRALIA reported NAROPIN problem on Feb 27, 2008. Female patient, 90 years of age, was diagnosed with nerve block and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: asphyxia, resuscitation. NAROPIN dosage: unknown. Patient recovered.

Naropin Side Effects Report #5642953-X
NAROPIN problem was reported by a Pharmacist from UNITED STATES on Feb 27, 2008. Male patient, 80 years of age, weighting 160.9 lb, was diagnosed with pain management and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: arrhythmia, cardiac arrest, coordination abnormal, fall, hypoventilation, sinus tachycardia. NAROPIN dosage: 20 MG EVERY HOUR TOP. Patient died on 02/15/2008.

Naropin Side Effects Report #5588523-3
Health Professional from JAPAN reported NAROPIN problem on Jan 07, 2008. Female patient, 41 years of age, weighting 198.4 lb, was diagnosed with epidural anaesthesia, sedation and was treated with NAROPIN. NAROPIN dosage: unknown. During the same period patient was treated with DIPRIVAN, ATONIN, XYLOCAINE, ISODINE. Patient died on 06/05/2007.

Naropin Side Effects Report #5531777-X
NAROPIN problem was reported by a Health Professional from NORWAY on Nov 26, 2007. Female patient, weighting 134.5 lb, was diagnosed with postoperative analgesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: atrioventricular block complete, cardiac arrest, overdose. NAROPIN dosage: 4.9 MG/KG. During the same period patient was treated with MARCAINE, FENTANYL, ACETAMINOPHEN. Patient recovered.

Naropin Side Effects Report #5554958-8
Health Professional from DENMARK reported NAROPIN problem on Dec 05, 2007. Male patient, weighting 172.0 lb, was diagnosed with neuromuscular blockade, anaesthesia, infection prophylaxis, hypotension, pain and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: nerve injury, paralysis. NAROPIN dosage: unknown. During the same period patient was treated with PROPOFOL, ULTIVA, ZINACEF, EFEDRIN, PAMOL. Patient recovered.

Naropin Side Effects Report #5576450-7
NAROPIN problem was reported by a Physician from JAPAN on Dec 26, 2007. Female patient, 37 years of age, was diagnosed with epidural anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: hypoxia. NAROPIN dosage: unknown. During the same period patient was treated with DIPRIVAN. Patient died.

Naropin Side Effects Report #5514641-1
Health Professional from NORWAY reported NAROPIN problem on Nov 09, 2007. Female patient, weighting 134.5 lb, was diagnosed with postoperative analgesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: atrioventricular block complete, cardiac arrest, overdose. NAROPIN dosage: 4.9 MG/KG. During the same period patient was treated with MARCAINE, FENTANYL, ACETAMINOPHEN. Patient recovered.

Naropin Side Effects Report #5518202-X
NAROPIN problem was reported by a Health Professional from DENMARK on Nov 06, 2007. Male patient, weighting 172.0 lb, was diagnosed with neuromuscular blockade, anaesthesia, infection prophylaxis, hypotension, pain and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: nerve injury, paralysis. NAROPIN dosage: unknown. During the same period patient was treated with PROPOFOL, ULTIVA, ZINACEF, EFEDRIN, PAMOL. Patient recovered.

Naropin Side Effects Report #5492257-3
Physician from NORWAY reported NAROPIN problem on Oct 17, 2007. Female patient, weighting 154.3 lb, was diagnosed with anaesthesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, overdose. NAROPIN dosage: unknown. During the same period patient was treated with MARCAINE. Patient recovered.

Naropin Side Effects Report #5466929-0
NAROPIN problem was reported by a Physician from JAPAN on Sept 14, 2007. Female patient, weighting 92.59 lb, was diagnosed with epidural anaesthesia, constipation, insomnia, abdominal pain lower, nerve injury and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: gait disturbance, hypoaesthesia, impaired work ability, insomnia, monoplegia, muscular weakness, radiculopathy, sensory disturbance. NAROPIN dosage: unknown. During the same period patient was treated with MAGNESIUM OXIDE, ALOSENN, ROHYPNOL, HALCION, MYONAL, METHYCOBAL. Patient recovered.

Naropin Side Effects Report #5405069-3
Physician from JAPAN reported NAROPIN problem on July 23, 2007. Male patient, 73 years of age, was diagnosed with epidural anaesthesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: diplegia. NAROPIN dosage: unknown. During the same period patient was treated with MARCAINE, FENTANYL. Patient recovered.

Naropin Side Effects Report #5417035-2
NAROPIN problem was reported by a Physician from JAPAN on Aug 07, 2007. Male patient, weighting 142.9 lb, was diagnosed with epidural anaesthesia, postoperative analgesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: monoparesis. NAROPIN dosage: unknown. During the same period patient was treated with MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, FENTANYL, ULTIVA, DIPRIVAN, EPHEDRIN. Patient recovered.

Naropin Side Effects Report #5419819-3
Physician from GERMANY reported NAROPIN problem on Aug 14, 2007. Female patient, 60 years of age, was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: hypersensitivity. NAROPIN dosage: unknown. During the same period patient was treated with MERONEM. Patient was hospitalized. Patient recovered.

Naropin Side Effects Report #5376172-1
NAROPIN problem was reported by a Consumer or non-health professional from BRAZIL on June 25, 2007. Female patient, 57 years of age, weighting 172.0 lb, was diagnosed with plastic surgery and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: demyelinating polyneuropathy. NAROPIN dosage: unknown. Patient recovered.

Naropin Side Effects Report #5380741-2
Health Professional from JAPAN reported NAROPIN problem on July 03, 2007. Male patient, 81 years of age, was diagnosed with epidural anaesthesia, induction of anaesthesia, maintenance of anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, stress cardiomyopathy. NAROPIN dosage: unknown. During the same period patient was treated with THIOPENTAL, VECURONIUM BROMIDE, NITROUS OXIDE W, OXYGEN, SEVOFLURANE. Patient recovered.

Naropin Side Effects Report #5381916-9
NAROPIN problem was reported by a Health Professional from JAPAN on July 03, 2007. Male patient, 78 years of age, weighting 112.4 lb, was diagnosed with epidural anaesthesia, induction of anaesthesia, maintenance of anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, stress cardiomyopathy. NAROPIN dosage: unknown. During the same period patient was treated with THIOPENTAL, VECURONIUM BROMIDE, NITROUS OXIDE W, SEVOFLURANE. Patient recovered.

Naropin Side Effects Report #5383154-2
Health Professional from JAPAN reported NAROPIN problem on June 28, 2007. Male patient, weighting 152.1 lb, was diagnosed with local anaesthesia, nerve block, infiltration anaesthesia, fluid replacement and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: clonic convulsion, electrocardiogram qrs complex prolonged, electrocardiogram t wave amplitude increased, sinus tachycardia. NAROPIN dosage: unknown. During the same period patient was treated with CARBOCAIN, FENTANEST. Patient recovered.

Naropin Side Effects Report #5384126-4
NAROPIN problem was reported by a Health Professional from JAPAN on July 05, 2007. Male patient, 74 years of age, was diagnosed with epidural anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: anaesthetic complication, blood pressure immeasurable, bradycardia, loss of consciousness, musculoskeletal stiffness, respiratory arrest. NAROPIN dosage: unknown. Patient recovered.

Naropin Side Effects Report #5386723-9
Health Professional from JAPAN reported NAROPIN problem on July 05, 2007. Female patient, 83 years of age, was diagnosed with pain, herpes zoster and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: somatoform disorder, transient ischaemic attack. NAROPIN dosage: CONTINUOUS EPIDURAL BLOCK 2 - 4 ML PER HOUR. During the same period patient was treated with ACYCLOVIR, DICLOFENAC. Patient recovered.

Naropin Side Effects Report #5387689-8
NAROPIN problem was reported by a Health Professional from JAPAN on July 02, 2007. Female patient, weighting 88.18 lb, was diagnosed with epidural anaesthesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: diplegia. NAROPIN dosage: unknown. During the same period patient was treated with MARCAINE, CARBOCAIN, XYLOCAINE. Patient recovered.

Naropin Side Effects Report #5400746-2
Physician from CHINA reported NAROPIN problem on July 17, 2007. Female patient, 25 years of age, was diagnosed with spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: back pain, pain in extremity. NAROPIN dosage: unknown. Patient was hospitalized. Patient recovered.

Naropin Side Effects Report #5376172-1
NAROPIN problem was reported by a Consumer or non-health professional from BRAZIL on June 25, 2007. Female patient, 57 years of age, weighting 172.0 lb, was diagnosed with plastic surgery and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: demyelinating polyneuropathy. NAROPIN dosage: unknown. Patient recovered.

Naropin Side Effects Report #5380741-2
Health Professional from JAPAN reported NAROPIN problem on July 03, 2007. Male patient, 81 years of age, was diagnosed with epidural anaesthesia, induction of anaesthesia, maintenance of anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, stress cardiomyopathy. NAROPIN dosage: unknown. During the same period patient was treated with THIOPENTAL, VECURONIUM BROMIDE, NITROUS OXIDE W, OXYGEN, SEVOFLURANE. Patient recovered.

Naropin Side Effects Report #5381916-9
NAROPIN problem was reported by a Health Professional from JAPAN on July 03, 2007. Male patient, 78 years of age, weighting 112.4 lb, was diagnosed with epidural anaesthesia, induction of anaesthesia, maintenance of anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, stress cardiomyopathy. NAROPIN dosage: unknown. During the same period patient was treated with THIOPENTAL, VECURONIUM BROMIDE, NITROUS OXIDE W, SEVOFLURANE. Patient recovered.

Naropin Side Effects Report #5383154-2
Health Professional from JAPAN reported NAROPIN problem on June 28, 2007. Male patient, weighting 152.1 lb, was diagnosed with local anaesthesia, nerve block, infiltration anaesthesia, fluid replacement and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: clonic convulsion, electrocardiogram qrs complex prolonged, electrocardiogram t wave amplitude increased, sinus tachycardia. NAROPIN dosage: unknown. During the same period patient was treated with CARBOCAIN, FENTANEST. Patient recovered.

Naropin Side Effects Report #5384126-4
NAROPIN problem was reported by a Health Professional from JAPAN on July 05, 2007. Male patient, 74 years of age, was diagnosed with epidural anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: anaesthetic complication, blood pressure immeasurable, bradycardia, loss of consciousness, musculoskeletal stiffness, respiratory arrest. NAROPIN dosage: unknown. Patient recovered.

Naropin Side Effects Report #5386723-9
Health Professional from JAPAN reported NAROPIN problem on July 05, 2007. Female patient, 83 years of age, was diagnosed with pain, herpes zoster and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: somatoform disorder, transient ischaemic attack. NAROPIN dosage: CONTINUOUS EPIDURAL BLOCK 2 - 4 ML PER HOUR. During the same period patient was treated with ACYCLOVIR, DICLOFENAC. Patient recovered.

Naropin Side Effects Report #5387689-8
NAROPIN problem was reported by a Health Professional from JAPAN on July 02, 2007. Female patient, weighting 88.18 lb, was diagnosed with epidural anaesthesia, spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: diplegia. NAROPIN dosage: unknown. During the same period patient was treated with MARCAINE, CARBOCAIN, XYLOCAINE. Patient recovered.

Naropin Side Effects Report #5400746-2
Physician from CHINA reported NAROPIN problem on July 17, 2007. Female patient, 25 years of age, was diagnosed with spinal anaesthesia and was treated with NAROPIN. After drug was administered, patient experienced the following problems/side effects: back pain, pain in extremity. NAROPIN dosage: unknown. Patient was hospitalized. Patient recovered.


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asphyxia, resuscitation, arrhythmia, cardiac arrest, coordination abnormal, fall, hypoventilation, sinus tachycardia, , was diagnosed with nerve block and was diagnosed with pain management and was diagnosed with epidural anaesthesia, sedation and