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Review Methylin Safety Reports submitted to FDA

Total Methylin reports: 8.
Methylin FDA safety alerts: 2005 .
Reported deaths: 1    Reported hospitalizations: 1.
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FDA Reported Methylin Side Effects: agitation, anxiety, disturbance in attention, adrenergic syndrome, therapeutic product contamination, memory impairment, headache, somnolence, impaired driving ability, peripheral coldness, paraesthesia.
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Methylin Side Effects Report #5451384-7
Consumer or non-health professional from UNITED STATES reported METHYLIN problem on Sept 11, 2007. Male patient, 32 years of age, weighting 200.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: disturbance in attention, headache, memory impairment, therapeutic product contamination. METHYLIN dosage: 5MG DAILY PO. Patient recovered.

Methylin Side Effects Report #5406367-X
METHYLIN problem was reported by a Pharmacist from UNITED STATES on July 20, 2007. Female patient was diagnosed with attention deficit/hyperactivity disorder, hypothyroidism, appetite disorder, pain and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: agitation. METHYLIN dosage: 7.5 MG, BID. During the same period patient was treated with OPTIVAR, VIGAMOX, SYNTHROID, MEGACE, DARVOCET, ATIVAN, LEXAPRO. Patient recovered.

Methylin Side Effects Report #5419764-3
Consumer or non-health professional from NETHERLANDS reported METHYLIN problem on Aug 07, 2007. Female patient was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: anxiety, hyperhidrosis, hypertension, muscle spasms, nausea, palpitations, paraesthesia, peripheral coldness. METHYLIN dosage: 7.5 MG, QD. Patient was hospitalized. Patient recovered.

Methylin Side Effects Report #5441749-1
METHYLIN problem was reported by a Pharmacist from UNITED STATES on Aug 29, 2007. Male patient, weighting 250.0 lb, was diagnosed with narcolepsy and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: impaired driving ability, somnolence. METHYLIN dosage: 2 -40MG- QID PO. Patient recovered.

Methylin Side Effects Report #5379535-3
Health Professional from UNITED STATES reported METHYLIN problem on June 20, 2007. Male patient, 57 years of age, was diagnosed with depressive symptom, disturbance in attention and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: anxiety, autoimmune hepatitis, haematocrit decreased, haemoglobin decreased. METHYLIN dosage: unknown. During the same period patient was treated with METHYLIN ER, CYCLOSPORINE, VENLAFAXINE, OMEPRAZOLE, HYDROCHLOROTHIAZIDE, FOSINOPRIL, VITAMIN. Patient recovered.

Methylin Side Effects Report #5387158-5
METHYLIN problem was reported by a Pharmacist from UNITED STATES on June 26, 2007. Male patient, 18 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: agitation, road traffic accident, traumatic brain injury. METHYLIN dosage: 7.5 MG, BID. Patient recovered.

Methylin Side Effects Report #5379535-3
Health Professional from UNITED STATES reported METHYLIN problem on June 20, 2007. Male patient, 57 years of age, was diagnosed with depressive symptom, disturbance in attention and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: anxiety, autoimmune hepatitis, haematocrit decreased, haemoglobin decreased. METHYLIN dosage: unknown. During the same period patient was treated with METHYLIN ER, CYCLOSPORINE, VENLAFAXINE, OMEPRAZOLE, HYDROCHLOROTHIAZIDE, FOSINOPRIL, VITAMIN. Patient recovered.

Methylin Side Effects Report #5387158-5
METHYLIN problem was reported by a Pharmacist from UNITED STATES on June 26, 2007. Male patient, 18 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with METHYLIN. After drug was administered, patient experienced the following problems/side effects: agitation, road traffic accident, traumatic brain injury. METHYLIN dosage: 7.5 MG, BID. Patient recovered.


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disturbance in attention, headache, memory impairment, therapeutic product contamination, agitation, , was diagnosed with attention deficit/hyperactivity disorder and was diagnosed with attention deficit/hyperactivity disorder, hypothyroidism, appetite disorder, pain and