FDA & Prescription Drugs

• Ortho Evra Patch Blood Clot Risk Requires New Warnings

  Shezad Malik MD JD | December 13, 2011 4:54 PM | 0 CommentsFort Worth, TX

  A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous...

• Complications from Pradaxa? Report them to the FDA!

  Steven Davis | December 13, 2011 1:25 PM | 0 CommentsChicago-Land, IL

  There has never been a more important time for Pradaxa users to vigilantly report complications from the drug. Specifically, users of the drug need to let physicians know of any symptoms of...

• FDA Delays Review of New Actos Combo Drug

  Orman Kimbrough, Jr. | December 13, 2011 9:35 AM | 1 CommentOrlando, FL

  The Federal Drug Administration delayed review of a Takeda Pharmaceuticals drug that is combined with Actos, a diabetes medication that has been linked to bladder cancer. Actos was approved by...

• Yasmin, Yaz Will Stay on the Market, Despite Blood Clot Dangers

  Camryn Hansen | December 12, 2011 9:31 PM | 0 CommentsCherry Hill, NJ

  Last Thursday, the FDA met to discuss the safety and future of several birth control drugs, including Yasmin and its sister pill Yaz, both manufactured by Bayer. These drugs contain a hormone...

• Teenager Suffers Debilitating Blood Clot from Using Yaz

  David Mittleman | December 10, 2011 1:48 PM | 0 CommentsLansing, MI

  A lot of controversy has swirled around Yaz recently because of its adverse side effects. Yaz is associated with a higher-than-normal risk of blood clots compared to older versions of oral...

• Yaz, Yasmin Blood Clots and the FDA

  Shezad Malik MD JD | December 10, 2011 12:20 PM | 0 CommentsFort Worth, TX

  This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing. The FDA advisory panel voted 19-5...

• Bayer Accused Of Marketing Birth Control For Unapproved Uses

  Michael Hill | December 09, 2011 12:11 PM | 0 CommentsCleveland, OH

  Claims are being made against Bayer, Germany’s largest drug maker, for marketing Yasmin® birth control pills for unapproved uses and misleading women about the health risks associated...

• Yaz Side Effects: FDA Requires Increase Warning For Yaz Blood Clot Risks

  Brett Emison | December 09, 2011 10:46 AM | 1 CommentKansas City, MO

  A Food and Drug Administration (FDA) advisory panel voted 21-5 to require drospirenone-containing birth control pills - including Yaz, Yasmin, Ocella, Beyaz, Safyral, and Vestura - to warn about...

• FDA Disappoints on Yaz and Yasmin

  Shezad Malik MD JD | December 08, 2011 9:35 PM | 1 CommentFort Worth, TX

  After a much publicized hearing, federal health experts said that drug labeling for Yaz and other drospirenone containing birth control pills should be updated to highlight recent data suggesting...

• Teratogenicity of Topiramate is Not New But the Warnings Are

  Michael Monheit | December 08, 2011 8:55 AM | 0 CommentsCentral Pennsylvania, PA

  The FDA is finally requiring the well-known antiepileptic drug Topiramate to carry a label that warns of topamax cleft palate birth defects. The FDA warning, which came out in March of 2011,...