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FDA Recall & Safety Alerts

FDA Recall & Safety Alerts

The Food and Drug Administration (FDA) is the government agency that monitors and regulates over-the-counter medications, prescription drugs, dietary supplements and other medical products in the United States. In an effort to provide the public with timely information on the products it monitors, the FDA releases safety alerts with information that may impact treatment and diagnostic choices for patients and healthcare professionals.

The pharmaceutical injury attorneys at Schlichter, Bogard & Denton want you to have the latest information released by the FDA. Please view the most recent FDA safety alerts and click on the link to learn more about the alert for these products.

Camolyn eye drops & Fisiolin nasal drops- Non-sterility voluntary recall

April 07, 2010 – US Oftalmi and the FDA posted notice of the nationwide recall of all over-the-counter eye drops and nasal drops. This recall was initiated due to conditions at the manufacturing facility that may affect the sterility of the products. Products that are non-sterile have the potential to cause eye infections that could lead to loss of sight. Read more.

Stalevo – FDA Ongoing Safety Review

Mar. 31, 2010- The FDA provided notice that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD). This trial may suggest patients taking Stalevo may be at an increased risk for the development of prostate cancer. Read more.

Cleviprex – Recall Update

Mar. 17, 2010- The Cleviprex recall announced earlier this year has been expanded to include four additional lots. The Medicines Company announced it is voluntarily expanding the recall of the injectable emulsion, Cleviprex. Read more.

Plavix – Reduced effectiveness in patients who are poor metabolizers of the drug

Mar. 12, 2010 – The FDA announced that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood clotting medication. Read more.

WinRho SDF – Risk of Intravascular Hemolysis

Mar. 10, 2010 – Cangene, Baxter and the FDA announced that notification has been sent to healthcare professional alerting them of cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF.Read more.

Invirase – Ongoing safety review of clinical trial data

Feb.23, 2010 – FDA notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir), antiviral medications given together to treat HIV infection. Read more.

Avandia – Ongoing Review of Cardiovascular Safety

Feb. 22, 2010 – The FDA sent notification to healthcare professional and patients that it will be reviewing the primary data from the clinical study, RECORD, on possible cardiovascular risks with Avandia, a diabetes drug. A number of observational studies of the cardiovascular safety of Avandia have been published. The FDA has been reviewing these on an ongoing basis, in addition to the clinical trial. Read more.

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