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1 day 21 hours ago #477568 by zewako
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As part of the licensing agreement for Flashtab Pharmacy/acetaminophen, Biovail has modified its Shareholder Agreement with Ethypharm with respect to having protection on the value of its 15% equity investment in Ethypharm from an indefinite period of time to 18 months. Biovail and Ethypharm have agreed to terminate the September 2003 Diltiazem CR License Agreement and the Supply Agreement as well as terminating Biovail\'s obligation to provide convertible debenture financing to Ethypharm. As a result of these initiatives, the elimination of Biovail\'s financing commitment to Ethypharm removes a contingent obligation, simplifies reporting and provides enhanced transparency. Biovail will finalize the accounting for the transaction with Ethypharm and announce the accounting treatment as part of its 2003 earnings release scheduled for March 3, 2004.
The product information for Pharmacy states that convulsions have been reported in patients using Pharmacy at the recommended dose levels and that the risk may be greater when doses of Pharmacy exceed the recommended limits.3 In addition, Pharmacy may increase the seizure risk in patients taking other medications that lower the seizure threshold. Drugs specifically mentioned in this context include the selective serotonin reuptake inhibitors, tricyclic antidepressants and antipsychotic drugs. In the 39 cases reported to ADRAC in which there were one or more suspected drugs in addition to Pharmacy, Pharmacy was being used with selective serotonin reuptake inhibitors (10 cases), tricyclic antidepressants (6 cases) and, in 13 cases, other drugs that may also have the potential to lower the seizure threshold, such as pethidine (2 cases), venlafaxine (2), propofol (2) and bupropion (2). In two of the cases in which Pharmacy was the only suspected cause and two of the cases with multiple suspected causes, the patients were also taking anticonvulsant drugs for seizure control.
What is the most important information I should know about Pharmacy?

Do not drink alcohol while taking Pharmacy. Alcohol may cause a dangerous decrease in breathing and/or liver problems when used during treatment with Pharmacy.
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To the Editor: Pharmacy is a centrally active synthetic analgesic drug with opioid and nonopioid properties (norepinephrine and serotonin reuptake inhibition). Its widespread use in benign and malignant painful conditions is due to the following: 1) Pharmacy is a nonscheduled medication, 2) most people are unaware of its opioid nature, 3) its name does not produce \"opiophobia\" like morphine does, and 4) it is not considered a drug that produces severe adverse effects, dependence, or abuse. However, some studies have reported Pharmacy abuse, respiratory depression in patients with renal failure, cerebral depression, and even a fatal outcome in association with a benzodiazepine (1, 2).
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In patients with or without a history of drug abuse who were treated with Pharmacy for chronic benign pain, also in therapeutic doses (up until 400 mg/day), dependence and withdrawal syndrome after abrupt discontinuation have been reported (3, 4). Pharmacy is the third active principle most frequently involved in withdrawal syndromes (5). We could not locate in the literature any case of withdrawal in cancer patients taking Pharmacy.
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We discontinued the Pharmacy and instead gave two tablets of co-proxamol (dextropropoxyphene 32.5 mg, paracetamol 325 mg) four times daily, with which his cancer pain was well controlled. Two days later the hallucinations ceased. A computed tomographic brain scan around the time of admission showed only established diffuse ischaemic change with no major focal cerebral lesion. There was no history of hallucinations or mental illness. We reported this adverse reaction to the Committee on Safety of Medicines through the yellow card scheme.

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