From the FDA MedWatch on October 17, 2008:

FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.

Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.

Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

Active ingredient(s): Azelastine HCl 

Dosage form: nasal spray

Manufacturer: Medpointe

Usage: seasonal allergic rhinitis

Approval Date: October 15, 2008

For more information visit http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

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Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

Active ingredient(s): Silodosin 4mg and 8mg

Dosage form: capsules

Manufacturer: Watson

Usage: treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.

Approval Date: October 8, 2008

For more information visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01902.html

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

Active ingredient(s): Lidocaine HCl

Dosage form: 3.5% Ophthalmic Gel

Manufacturer: Akorn

Usage: a local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures

Approval Date: October 7, 2008

For more information visit http://www.fda.gov/cder/foi/label/2008/022221lbl.pdf

Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time.  The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.

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