Tacoma Personal Injury Lawyer - Defective and Dangerous Products

Birth Control Patch Gets Updated Label

Jenny Albano — Sun, 20 Jan 2008 17:29:48 GMT

The FDA approved new changes to Ortho Evra Contraceptive Transdermal Patch's label on Friday, January 18. The label will include the results of a study that found that users who use the birth control patch are at a higher risk of developing blood clots, or known as venous thromboembolism (VTE), than for women who use birth control pills.

The study was conducted on women from 15-44 and illustrated the same results as previous studies.

In September 2006, FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they were not at increased risk compared to women using birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate.

Ortho Evra is a prescription patch that releases an estrogen hormone and a progestin hormone through the skin into the blood stream. Women using this product will be exposed to around 60% more estrogen than those who use regular birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen can increase the risk of side effects such as VTE. The FDA believes that Ortho Evra is safe and effective when used according to the labeling, which states that women with concerns or risk factors for blood clots should talk with their doctor about using Ortho Evra.

For more information on this subject, please refer to our section on FDA and Prescription Drugs.

Originally posted at InjuryBoard by Jenny Albano

More Toys Recalled Due to Excess Levels of Lead

Jenny Albano — Wed, 22 Aug 2007 18:08:32 GMT

Today, August 22, four more toys have been recalled due to a risk of lead exposure. Exposure to lead has been shown to cause brain and kidney damage, especially in children. Lead poisoning symptoms include, among others, nausea, headaches, constipation, seizures, and coma.

The CPSC announced that SpongeBob SquarePants Address Books and Journals, Thomas and Friends and Curious George Spinning Tops and Tin Pails, Children's Divine Inspiration Charm Bracelets, TOBY & ME Jewelry Sets are all being recalled due to a violation of the lead paint standard or a risk of excess lead exposure.

About 250,000 SpongeBob Squarepants Address Books and Journals are being recalled.

The recall involves address books and journals with SpongeBob SquarePantsâ„¢ character on the front cover and a black metal spiral binding. The UPC numbers (80773007505 for the address book and 80773002260, 80773075501 and 80773007551 for the journal) are printed on the back covers.

Around 66,000 spinning tops and about 4,700 pails are being recalled. The tops and pails are made of metal and have wooden handles. The tops have Curious George, Thomas and Friends, or a circus scene painted on them and the pails have either a Curious George scene, Thomas and Friends scene, or are painted in red and yellow.

The charm bracelets have silver-colored charms, which include angels, crosses, and hearts, and clear and pink beads that are strung on a silver-colored chain.

The three recalled TOBY & ME jewelry sets include: a princess pink and clear crystal bead necklace and bracelet set with a painted metallic crown pendant; a pink and white pearl necklace and bracelet set with a painted metallic poodle pendant; and a pink pearl necklace, earrings and ring set.

For information on how parents can stop their children from being exposed to lead poisoning see this Consumer Report article.

For more information on this subject, please refer to our section on Defective and Dangerous Products.

Originally posted at InjuryBoard by Jenny Albano

Avandia and Other Diabetes Drugs Get "Black Box" Warning

Jenny Albano — Tue, 14 Aug 2007 20:18:40 GMT

The FDA has announced that some Type 2 diabetes drugs will be given a "black box" warning, which is the agency's strongest warning, about the risk of heart failure. The upgraded warning states that the drugs may cause or worsen heart failure in certain diabetic patients.

After a review the FDA decided that the entire thiazolidinedione class of antidiabetic drugs needed the warning added to their labels. The drugs that will receive the warning include Avandia, Actos, Avandaryl, Avandamet ,and Duetact. The FDA has asked the manufacturers, GlaxoSmithKline and Takeda, to act upon its request.

"This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

The FDA's review found cases where patients using these drugs incurred weight gain and edema, which are both signs of heart failure.

The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered.

The warning also lists that patients who have serious heart failure and who have marked limits on their activity should not use these drugs.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jenny Albano