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Review Innohep Safety Reports submitted to FDA

Total Innohep reports: 46.
Innohep FDA safety alerts: No.
Reported deaths: 15    Reported hospitalizations: 17.
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FDA Reported Innohep Side Effects: pulmonary embolism, caesarean section, cardiac arrest, mental status changes, convulsion, neonatal respiratory distress syndrome, lymphoma, pre-eclampsia, procedural pain, injection site bruising, heparin-induced thrombocytopenia.
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Innohep Side Effects Report #5652187-0
Physician from GERMANY reported INNOHEP problem on Feb 18, 2008. Female patient, 77 years of age, was diagnosed with thrombosis prophylaxis, grand mal convulsion, rash, supraventricular tachycardia, asthma, hypertension and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. INNOHEP dosage: 0.4 ML, DAILY, SUBCUTANEOUS. During the same period patient was treated with CARBAMAZEPINE, PREDNISONE, DIGOXIN, THEOPHYLLINE, DIGITOXIN, PANTOPRAZOLE, DYTIDE. Patient died on 05/08/2003.

Innohep Side Effects Report #5652191-2
INNOHEP problem was reported by a Pharmacist from FRANCE on Feb 20, 2008. Female patient, 70 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: haematuria, osteoporosis. INNOHEP dosage: unknown. During the same period patient was treated with ACTONEL, CACIT. Patient recovered.

Innohep Side Effects Report #5663401-X
Physician from DENMARK reported INNOHEP problem on Feb 21, 2008. Female patient was treated with INNOHEP. INNOHEP dosage: unknown. Patient died.

Innohep Side Effects Report #5663882-1
INNOHEP problem was reported by a Physician from FRANCE on Mar 05, 2008. Female patient, 68 years of age, weighting 132.3 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: abasia, condition aggravated, haematuria, osteoporosis. INNOHEP dosage: unknown. During the same period patient was treated with ACTONEL, CACIT. Patient recovered.


Innohep Side Effects Report #5671595-5
Physician from GERMANY reported INNOHEP problem on Feb 29, 2008. Female patient, 50 years of age, weighting 220.5 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism, underdose. INNOHEP dosage: unknown. During the same period patient was treated with METAMIZOL, EUTHYRON. Patient died on 02/23/2008.

Innohep Side Effects Report #5680024-7
INNOHEP problem was reported by a Consumer or non-health professional from on Mar 10, 2008. Female patient, 77 years of age, was diagnosed with thrombosis prophylaxis, grand mal convulsion and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: nausea, stevens-johnson syndrome, toxic epidermal necrolysis. INNOHEP dosage: (0.4 ML, DAILY), SUBCUTANEOUS. During the same period patient was treated with TIMONIL RETARD, PULMICORT, SEREVENT, EUNERPAN, ISOPTIN, MARCUMAR, PLAVIX, CORNEREGEL. Patient died on 05/08/2003.

Innohep Side Effects Report #5586166-9
Physician from reported INNOHEP problem on Dec 20, 2007. Female patient, 69 years of age, weighting 147.7 lb, was diagnosed with atrial fibrillation and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, malaise, nausea, syncope. INNOHEP dosage: unknown. During the same period patient was treated with BISOPROLOL FUMARATE. Patient recovered.

Innohep Side Effects Report #5607803-6
INNOHEP problem was reported by a Physician from FRANCE on Jan 11, 2008. Female patient, 39 years of age, was diagnosed with deep vein thrombosis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: hepatitis. INNOHEP dosage: unknown. During the same period patient was treated with PREVISCAN, NEXIUM, PREDNISONE, AZATHIOPRINE. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5545795-9
Physician from FRANCE reported INNOHEP problem on Nov 23, 2007. Female patient, 87 years of age, was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: dehydration, gastric ulcer haemorrhage, rectal haemorrhage, renal failure acute, rhabdomyolysis. INNOHEP dosage: unknown. During the same period patient was treated with CYCLO, VASTAREL, RAMIPRIL, MIXTARD, AMLODIPINE BESYLATE, LASIX, LIPANTHYL. Patient was hospitalized. Patient recovered.


Innohep Side Effects Report #5557385-2
INNOHEP problem was reported by a Physician from SPAIN on Nov 27, 2007. Male patient was diagnosed with protein c deficiency and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: pierre robin syndrome. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5528532-3
Physician from reported INNOHEP problem on Nov 06, 2007. Female patient, 70 years of age, was diagnosed with atrial fibrillation and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: malaise, nausea. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5480250-6
INNOHEP problem was reported by a Health Professional from UNITED STATES on Sept 18, 2007. Female patient, 73 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: blister, postoperative wound complication, wound secretion. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5480251-8
Health Professional from UNITED STATES reported INNOHEP problem on Sept 18, 2007. Female patient, 79 years of age, weighting 149.9 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: postoperative wound complication, wound secretion. INNOHEP dosage: unknown. During the same period patient was treated with BENDROFLUAZIDE, SIMVASTATIN, ADALAT. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5483207-4
INNOHEP problem was reported by a Health Professional from UNITED STATES on Sept 24, 2007. Male patient, 84 years of age, weighting 141.1 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: accidental overdose, activated partial thromboplastin time prolonged, blood potassium increased, blood sodium decreased. INNOHEP dosage: unknown. During the same period patient was treated with PROSCAR, DIOVAN, NORVASC. Patient was hospitalized. Patient recovered.


Innohep Side Effects Report #5485600-2
Health Professional from reported INNOHEP problem on July 25, 2007. Male patient, 32 years of age, weighting 172.0 lb, was diagnosed with dialysis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: convulsion, hypotension. INNOHEP dosage: unknown. During the same period patient was treated with KETOVITE, SEVELAMER, ALFACALCIDOL. Patient recovered.

Innohep Side Effects Report #5500103-4
INNOHEP problem was reported by a Health Professional from on Oct 09, 2007. Female patient, 79 years of age, weighting 149.9 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: post procedural complication, wound secretion. INNOHEP dosage: unknown. During the same period patient was treated with BENDROFLUAZIDE, SIMVASTATIN, ADALAT. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5500104-6
Health Professional from reported INNOHEP problem on Oct 09, 2007. Female patient, 73 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: postoperative wound complication, secretion discharge, wound secretion. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5451964-9
INNOHEP problem was reported by a Physician from CANADA on Aug 28, 2007. Female patient, 87 years of age, was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, hyperkalaemia, pulmonary embolism. INNOHEP dosage: unknown. During the same period patient was treated with BACTRIM, LOVENOX, HEPARIN. Patient died.

Innohep Side Effects Report #5474679-X
Health Professional from CANADA reported INNOHEP problem on Sept 13, 2007. Male patient was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: accidental overdose, blood potassium increased, blood sodium decreased. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.


Innohep Side Effects Report #5410355-7
INNOHEP problem was reported by a Physician from on July 24, 2007. Female patient, 79 years of age, was diagnosed with pulmonary embolism and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: convulsion, multiple fractures, pulmonary embolism, road traffic accident, subdural haematoma. INNOHEP dosage: unknown. During the same period patient was treated with ENOXAPARIN. Patient died on 07/01/2007.

Innohep Side Effects Report #5420766-1
Pharmacist from IRELAND reported INNOHEP problem on Aug 02, 2007. Male patient, 61 years of age, was diagnosed with prophylaxis, staphylococcal infection and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: toxic epidermal necrolysis. INNOHEP dosage: unknown. During the same period patient was treated with ZOTON, VANCOMYCIN, OMEPRAZOLE, ENOXAPARIN, DICLOFENAC, VELOSEF, FUCIDINE CAP, FLAGYL. Patient died.

Innohep Side Effects Report #5380273-1
INNOHEP problem was reported by a Physician from on June 19, 2007. Female patient, 62 years of age, weighting 198.4 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: ankle fracture, pulmonary embolism, tibia fracture. INNOHEP dosage: unknown. Patient died on 06/01/2007.

Innohep Side Effects Report #5392933-7
Physician from UNITED STATES reported INNOHEP problem on July 03, 2007. Female patient, 65 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, dental caries, dislocation of joint prosthesis, mobility decreased, pulmonary embolism, surgical procedure repeated. INNOHEP dosage: unknown. Patient died on 05/14/2007.

Innohep Side Effects Report #5404295-7
INNOHEP problem was reported by a Physician from on July 17, 2007. Female patient, 86 years of age, was diagnosed with thrombophlebitis superficial and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: renal failure acute, rhabdomyolysis. INNOHEP dosage: 20,000 ANTI XA IU/ML, SUBCUTANEOUS. Patient recovered.

Innohep Side Effects Report #5380273-1
Physician from reported INNOHEP problem on June 19, 2007. Female patient, 62 years of age, weighting 198.4 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: ankle fracture, pulmonary embolism, tibia fracture. INNOHEP dosage: unknown. Patient died on 06/01/2007.

Innohep Side Effects Report #5392933-7
INNOHEP problem was reported by a Physician from UNITED STATES on July 03, 2007. Female patient, 65 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, dental caries, dislocation of joint prosthesis, mobility decreased, pulmonary embolism, surgical procedure repeated. INNOHEP dosage: unknown. Patient died on 05/14/2007.

Innohep Side Effects Report #5404295-7
Physician from reported INNOHEP problem on July 17, 2007. Female patient, 86 years of age, was diagnosed with thrombophlebitis superficial and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: renal failure acute, rhabdomyolysis. INNOHEP dosage: 20,000 ANTI XA IU/ML, SUBCUTANEOUS. Patient recovered.

Innohep Side Effects Report #5762008-3
INNOHEP problem was reported by a Pharmacist from on May 19, 2008. Male patient, 83 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, cardiovascular disorder, nausea, overdose, vertigo. INNOHEP dosage: unknown. During the same period patient was treated with INEGY, ATACAND HCT, INSPRA, FUROSEMIDE, ACETYLSALICYL ACID. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5769153-7
Physician from FRANCE reported INNOHEP problem on May 26, 2008. Male patient, weighting 14.99 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: congenital renal disorder. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5779710-X
INNOHEP problem was reported by a Physician from FRANCE on June 02, 2008. Male patient, 78 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, heparin-induced thrombocytopenia, hepatic failure, ischaemia, multi-organ failure, renal failure. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5779731-7
Physician from FRANCE reported INNOHEP problem on June 02, 2008. Male patient, 78 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, heparin-induced thrombocytopenia, hepatic failure, multi-organ failure, peripheral ischaemia, renal failure. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5797191-7
INNOHEP problem was reported by a Physician from FRANCE on June 12, 2008. Female patient, 59 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: feeling cold, hyperhidrosis, respiratory disorder, tremor. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5797192-9
Physician from FRANCE reported INNOHEP problem on June 12, 2008. Male patient, 78 years of age, weighting 220.5 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, amputation, arterial thrombosis, blood lactic acid abnormal, embolism, heparin-induced thrombocytopenia, hepatic failure, multi-organ failure, peripheral ischaemia. INNOHEP dosage: unknown. During the same period patient was treated with HYZAAR, ACTRAPID. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5733185-5
INNOHEP problem was reported by a Physician from FRANCE on Apr 22, 2008. Male patient, 84 years of age, was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, condition aggravated, haematuria, haemorrhagic anaemia. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5736887-X
Physician from IRELAND reported INNOHEP problem on Apr 23, 2008. Female patient, weighting 6.17 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: apgar score low, exophthalmos congenital. INNOHEP dosage: unknown. During the same period patient was treated with MEPERIDINE, PROCHLORPERAZINE MALEATE. Patient recovered.

Innohep Side Effects Report #5747230-4
INNOHEP problem was reported by a Pharmacist from GERMANY on May 05, 2008. Male patient, 83 years of age, was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, cardiovascular disorder, nausea, vertigo. INNOHEP dosage: unknown. During the same period patient was treated with INEGY, ATACAND, INSPA, FUROSEMIDE, PLUS. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5698365-6
Physician from reported INNOHEP problem on Mar 20, 2008. Male patient was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: congenital renal disorder. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5362690-9
INNOHEP problem was reported by a Physician from UNITED STATES on May 29, 2007. Female patient was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: shock. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5371059-2
Physician from reported INNOHEP problem on June 11, 2007. Female patient, 65 years of age, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, dental caries, dislocation of joint prosthesis, mobility decreased, procedural complication, pulmonary embolism. INNOHEP dosage: unknown. Patient died on 05/14/2007.

Innohep Side Effects Report #5343546-4
INNOHEP problem was reported by a Physician from UNITED STATES on May 15, 2007. Female patient was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. INNOHEP dosage: unknown. Patient died on 05/14/2007.

Innohep Side Effects Report #5295515-0
Physician from UNITED KINGDOM reported INNOHEP problem on Mar 22, 2007. Female patient, weighting 7.54 lb, was diagnosed with deep vein thrombosis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: acute lymphocytic leukaemia, hypercalcaemia, skin discolouration. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5296121-4
INNOHEP problem was reported by a Physician from on Mar 22, 2007. Female patient, 70 years of age, weighting 132.3 lb, was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism, respiratory distress, tachycardia. INNOHEP dosage: unknown. Patient died on 02/01/2007.

Innohep Side Effects Report #5300419-0
Physician from reported INNOHEP problem on Mar 28, 2007. Female patient was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: shock. INNOHEP dosage: unknown. Patient recovered.

Innohep Side Effects Report #5255859-5
INNOHEP problem was reported by a Health Professional from FRANCE on Feb 14, 2007. Male patient, 78 years of age, weighting 200.6 lb, was diagnosed with atrial fibrillation, atrial flutter, lung disorder and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: cardiac tamponade, cardiogenic shock, international normalised ratio increased, neisseria infection, overdose, respiratory tract infection bacterial. INNOHEP dosage: unknown. During the same period patient was treated with PREVISCAN, CORDARONE, AUGMENTIN, ATROVENT, FLIXOTIDE, ACTRAPID. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5258715-1
Health Professional from UNITED STATES reported INNOHEP problem on Mar 06, 2007. Male patient, 58 years of age, weighting 253.5 lb, was diagnosed with thrombosis prophylaxis and was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: cognitive disorder, mental status changes, neoplasm progression. INNOHEP dosage: unknown. Patient was hospitalized. Patient recovered.

Innohep Side Effects Report #5285144-7
INNOHEP problem was reported by a Physician from UNITED STATES on Mar 13, 2007. Female patient, 70 years of age, weighting 132.3 lb, was treated with INNOHEP. After drug was administered, patient experienced the following problems/side effects: pulmonary embolism. INNOHEP dosage: unknown. Patient died.


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