FDA

Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease.

The problem is that rotigotine, the active ingredient, may crystallize in the patch. If that happens, less drug is available to be absorbed through the skin and so the efficacy of the products may vary. The crystallized drug may cause a patch to have snowflake-like patterns. The more snowflakes, the greater the chance that the patch won't work properly.

Because of this, new patients should not be started on Neupro. Patients already using the patch should be slowly titrated off it, and started on an alternative treatment as needed. Patients should not abruptly discontinue treatment with Neupro. The down-titration should proceed according to guidelines in the labeling, using patches that are unaffected or minimally affected by the crystallization.

FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information is preliminary and there is scientific uncertainty, FDA is not taking regulatory action at this point, and is not advising health care professionals to stop using the drugs. FDA is continuing to evaluate the safety of these products, and will issue updates as more information becomes available.

• CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid)

One of the ongoing safety reviews concerns two drugs used to prevent organ rejection, CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid). CellCept is approved to prevent heart, liver and kidney transplant rejection. Myfortic is approved to prevent kidney transplant rejection.

FDA news

On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. This letter, which also gave patient management and treatment recommendations, was an update to two earlier communications.

FDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals located in Philadelphia, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients with hemophilia A.

Xyntha is produced without additives from human or animal material. This provides hemophilia A patients with an additional treatment option that can further minimize the risk of infection from the product.

Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein.

To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of any human or animal material.

FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorpheniramine, an antihistamine. Overdoses of hydrocodone can result in respiratory depression and death. FDA has reviewed over a hundred adverse event reports associated with this product. Twenty four reports were in children under the age of six, nine of whom died.

Additional Information:

FDA MedWatch Safety Alert. Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension). March 11, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tussionex

FDA Press Release. FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone. March 11, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html

Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing forms of multiple sclerosis.

Signs of liver injury, such as elevated total bilirubin and significantly elevated serum hepatic enzymes, have occurred as early as six days after the first dose of Tysabri. These signs can also occur for the first time even in patients who have taken multiple doses of Tysabri. Some patients had liver injury that recurred after rechallenge with the drug, which provides evidence that Tysabri caused the injury.

FDA issued a public health advisory informing the public about reports of serious adverse events in patients who received bolus injections of heparin sodium primarily from multi-dose vials manufactured by Baxter Healthcare Corporation

More Information

http://www.fda.gov/CDER/drug/infopage/heparin/public_health_update.htm

http://www.fda.gov/CDER/drug/advisory/heparin.htm