FDA MedWatch – Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review

FDA notified healthcare professionals and patients that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation – Parkinson’s Disease (STRIDE-PD), that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer. Other controlled clinical trials evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer. Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing Stalevo and Comtan. Patients should not stop taking their medication unless directed to do so by their healthcare professional.

CLICK HERE to read the complete MedWatch safety summary including a link to the Drug Safety Communication.

FDA MedWatch – MasXtreme Capsules (Natural Wellness) – product contains undeclared drug ingredient

Natural Wellness and FDA notified consumers that MasXtreme, a product sold as a dietary supplement contains aildenafil close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile as well as the drug phentolamine which is an alpha-adrenergic blocker. This may pose a threat to consumers because aildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Common side effects of phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc. Consumers who have purchased MasXtreme capsules are urged to immediately discontinue their use.

CLICK HERE to read the MedWatch safety summary, including a link to the company Press Release.

FDA MedWatch – Rotarix Vaccine: Update to Clinicians and Public Health Professionals

FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA’s recommendation is a precaution taken while the agency learns more about the situation.

FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.

There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses.

Additional information, including information for healthcare professionals and parents, is provided in the document below.

CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the Update statement from FDA.

FDA MedWatch – Boston Scientific Implantable Cardioverter Defibrillators: Recall

FDA notified healthcare professionals that FDA has been notified by Boston Scientific that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted.

FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted.

Product families included in this advisory include Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality.

CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the FDA Statement.

FDA MedWatch – Zocor (simvastatin): increased risk of muscle injury with high doses

FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the “statin” class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.

Recommendations for healthcare professionals, recommendations for patients and a data summary of information used in this ongoing review are provided in the Drug Safety Communication.

CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the Safety Communication and current Prescribing Information.

FDA MedWatch – Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall

FDA notified healthcare professionals of the Class 1 recall of certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including kits and trays, sold by other companies in which the Q-Syte Luer Access device is a component.

This device is used with other infusion therapy products to administer therapies, such as chemotherapy, blood and fluids into the intravenous system. The affected BD products were distributed from August 1, 2008 through February 1, 2010.

These lots of the BD Q-Syte Luer Access Split Septum devices are defective, which may result in air bubbles leaking into the infusion system and into the patient’s bloodstream, resulting in an air embolism. In addition, these defective devices may result in leakage of therapy being infused and result in incomplete inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in serious injuries or death.

For specific information on the affected products, see the list of recalled devices in the appendix of the Initial Communication.

CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the Initial Communication and Recall Notice.

FDA MedWatch – Cleviprex (clevidipine butyrate): Recall (Update)

[UPDATE] The December 2009 recall has been expanded to include four additional lots with the lot numbers and expiration dates noted in the firm press release of March 17, 2010.

[Posted 12/17/2009] The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.

CLICK HERE to see the company press release for information on specific lots affected by this recall.

OHRP Educational Videos

OHRP is pleased to announce the availability of two educational videos developed by the Division of Education and Development that provide information on topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human subjects of research described at 45 CFR part 46.

One video discusses research use of human biological specimens and other private information; it can be accessed at: http://videocast.nih.gov/ram/ohrp_kaneshiro.ram.

The second video discusses reviewing and reporting unanticipated problems and adverse events; it can be assessed at: http://videocast.nih.gov/ram/ohrp_carome.ram.

(If a hyperlink does not work because the URL wraps to next line, paste the entire URL into your browser to access the video.)

FDA MedWatch – Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall

FDA and Gyrus ACMI notified healthcare professionals of a Class I recall of Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm. This device is implanted for ventilation or drainage of the middle ear. Units of the product in lot number MH136952 have been shipped without being sterilized. This product was manufactured only on December 17, 2009 and distributed only on December 22, 2009. Patients should contact their physicians to discuss symptoms that may result from use of the affected products.

CLICK HERE to read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice.

FDA MedWatch – Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall

Teleflex Incorporated notified healthcare professionals of the recall of all lots of Arrow Select IV Tubing Sets, accessories, and certain lots of arterial embolectomy catheters because it has been determined that product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged, and if product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death.

Consumers who have products with the part numbers notice in the firm’s press release should stop using and return the items to Arrow International. Customers can find the entire affected product list at www.teleflexmedical.com.

CLICK HERE to read the MedWatch safety summary, including a link to the firm’s Press Release.