From the FDA MedWatch on May 8, 2009:

OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Read the complete MedWatch 2009 Safety summary, including a link to the OSI Dear Healthcare Professional Letter, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Tarceva

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From the FDA MedWatch on February 26, 2009:

FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.

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 Like any printed material, it may become out-of-date over time.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.

From the FDA MedWatch on February 23, 2009:

FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary.

Read the MedWatch 2009 safety summary, including a link to the “Information for Healthcare Professionals” sheet, at

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zonisamide

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.

From the FDA MedWatch on February 19, 2009:

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.

From the FDA MedWatch on February 4, 2009:

FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris.

FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA’s MedWatch Adverse Event Reporting program.

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.

From the FDA MedWatch on January 16, 2009:

FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics.

The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products. Read the MedWatch 2009 safety summary, including links to the Public Health Advisory and “Dear Colleague” letter, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Anesthetics

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.

From the FDA Medwatch on December 31, 2008: 

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at:  

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep

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.

From the FDA MedWatch on December 11, 2008:

FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.

FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional.

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.

From the FDA MedWatch on December 2, 2008:

FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

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. 

From the FDA MedWatch on November 24, 2008:

FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided below.

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.