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Review Akarin Safety Reports submitted to FDA

Total Akarin reports: 13.
Akarin FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 4.
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FDA Reported Akarin Side Effects: weight decreased, malaise, hepatitis toxic, hepatic cyst, dizziness, white blood cell count decreased, neutrophil count decreased, vertigo, screaming, nightmare, nausea.
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Akarin Side Effects Report #5679279-4
Consumer or non-health professional from DENMARK reported AKARIN problem on Mar 07, 2008. Female patient, 36 years of age, was diagnosed with depression, oral contraception and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, encephalitis, malaise, no therapeutic response, palpitations, tachycardia. AKARIN dosage: 60 MG QD PO. During the same period patient was treated with SEROQUEL, DELEPSINE, LAMICTAL, MINULET. Patient died on 02/23/2007.

Akarin Side Effects Report #5688132-1
AKARIN problem was reported by a Health Professional from DENMARK on Mar 13, 2008. Female patient, child 2 years of age, weighting 4.94 lb, was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: feeding disorder neonatal, neonatal disorder, neonatal tachycardia, restlessness, tremor neonatal. AKARIN dosage: 60 MG QD TRANSPLACENTAL. Patient recovered.

Akarin Side Effects Report #5598131-6
Consumer or non-health professional from DENMARK reported AKARIN problem on Jan 02, 2008. Male patient, 53 years of age, was diagnosed with depression and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: atrophy, tremor. AKARIN dosage: 60 MG QD PO. During the same period patient was treated with CYMBALTA, SERTRALINE. Patient recovered.

Akarin Side Effects Report #5538379-X
AKARIN problem was reported by a Health Professional from DENMARK on Nov 20, 2007. Female patient, 59 years of age, weighting 132.3 lb, was diagnosed with depression and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: dizziness, hepatic cyst, hepatitis toxic, malaise, weight decreased. AKARIN dosage: 15 MG QD PO. During the same period patient was treated with CITALOPRAM HYDROBROMIDE, EMPERAL, ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Akarin Side Effects Report #5531602-7
Health Professional from DENMARK reported AKARIN problem on Nov 12, 2007. Male patient, 53 years of age, was diagnosed with depression and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: cerebral atrophy, tremor. AKARIN dosage: 60 MG QD PO. During the same period patient was treated with CYMBALTA. Patient recovered.

Akarin Side Effects Report #5480866-7
AKARIN problem was reported by a Health Professional from DENMARK on Sept 19, 2007. Male patient, 53 years of age, was diagnosed with depression and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: tremor. AKARIN dosage: 60 MG QD PO. During the same period patient was treated with CYMBALTA. Patient recovered.

Akarin Side Effects Report #5451100-9
Health Professional from DENMARK reported AKARIN problem on Aug 28, 2007. Female patient, 59 years of age, weighting 132.3 lb, was diagnosed with depression and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: dizziness, hepatic cyst, hepatitis toxic, malaise, weight decreased. AKARIN dosage: 15 MG QD PO. During the same period patient was treated with CITALOPRAM HYDROBROMIDE. Patient was hospitalized. Patient recovered.

Akarin Side Effects Report #5408180-6
AKARIN problem was reported by a Health Professional from DENMARK on July 24, 2007. Female patient, 59 years of age, weighting 132.3 lb, was diagnosed with depression and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: dizziness, hepatic cyst, hepatitis toxic, malaise, weight decreased. AKARIN dosage: 20 MG QD PO. During the same period patient was treated with CITALOPRAM HYDROBROMIDE. Patient was hospitalized. Patient recovered.

Akarin Side Effects Report #5736314-2
Consumer or non-health professional from DENMARK reported AKARIN problem on Apr 22, 2008. Female patient, weighting 4.94 lb, was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: abnormal faeces, feeding disorder neonatal, neonatal tachycardia, psychomotor hyperactivity, respiratory rate increased, restlessness, tremor neonatal. AKARIN dosage: 60 MG QD TRANSPLACENTAL. Patient recovered.

Akarin Side Effects Report #5705913-6
AKARIN problem was reported by a Health Professional from DENMARK on Mar 25, 2008. Female patient, 36 years of age, was diagnosed with depression, oral contraception and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, encephalitis, tachycardia, thyroiditis. AKARIN dosage: 30 MG QD PO. During the same period patient was treated with SEROQUEL, DELEPSINE, LAMICTAL, MINULET. Patient died on 02/23/2007.

Akarin Side Effects Report #5712678-0
Consumer or non-health professional from DENMARK reported AKARIN problem on Apr 04, 2008. Female patient, 36 years of age, was diagnosed with depression, oral contraception and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, encephalitis, malaise, tachycardia, thyroiditis. AKARIN dosage: 30 MG QD PO. During the same period patient was treated with SEROQUEL, DELEPSINE, LAMICTAL, MINULET. Patient died on 02/23/2007.

Akarin Side Effects Report #5724381-1
AKARIN problem was reported by a Consumer or non-health professional from DENMARK on Apr 11, 2008. Female patient, 36 years of age, was diagnosed with depression, oral contraception and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: aortic arteriosclerosis, aortic valve sclerosis, arteriosclerosis coronary artery, bacterial infection, cardiac arrest, cerebrospinal fluid retention, chest discomfort, conjunctival haemorrhage. AKARIN dosage: 30 MG QD;PO. During the same period patient was treated with SEROQUEL, VALPROATE, LAMICTAL, MINULET. Patient died on 02/23/2007.

Akarin Side Effects Report #5259881-4
Pharmacist from DENMARK reported AKARIN problem on Feb 20, 2007. Female patient was diagnosed with depression, post coital contraception and was treated with AKARIN. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, muscular weakness, syncope. AKARIN dosage: 10 MG QD PO. During the same period patient was treated with NORLEVO. Patient was hospitalized. Patient recovered.


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