European Medicines Agency recommends restricting the use of oral moxifloxacin-containing medicines
Finalising a review of the safety of moxifloxacin-containing medicines for oral use, the European Medicines Agency (EMEA) has concluded that these medicines should only be prescribed in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.
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EMEA recommendation on use of angiotensin II receptor antagonists during pregnancy
The European Medicines Agency (EMEA) has recommended that the product information of all centrally authorised angiotensin II receptor antagonists be harmonised, regarding their use during pregnancy. Following a review of the safety of these medicines during pregnancy, the EMEA's Committee for Medicinal Products for Human Use (CHMP), at its April 2008 meeting, recommended that the product information should state that the use of angiotensin II receptor antagonists should be avoided in the first three months of pregnancy.
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FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone
The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events - including death - associated with the misuse and inappropriate use of this potent cough medication.
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Wyeth Europa Ltd withdraws its marketing authorisation application for Pristiqs (desvenlafaxine)
The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its
decision to withdraw the application for a centralised marketing authorisation for the medicine Pristiqs
(desvenlafaxine) 50mg and 100mg prolonged release tablets.
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Actelion withdraws its application for an extension of indication for Zavesca
The European Medicines Agency (EMEA) has been formally notified by Actelion of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Zavesca (miglustat).
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FDA Licenses New Hemophilia Treatment
The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.
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Risk of peripheral neuropathy with Sebivo (telbivudine)
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended that new warnings be included in the product information for Sebivo (telbivudine), from Novartis Europharm Ltd. This warning is intended to inform doctors about the risk of peripheral neuropathy in patients with chronic hepatitis B who are being treated with Sebivo.
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Finalising a review of the safety of moxifloxacin-containing medicines for oral use, the European Medicines Agency (EMEA) has concluded that these medicines should only be prescribed in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. 
The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events - including death - associated with the misuse and inappropriate use of this potent cough medication.