FDA & Prescription Drugs

• CellCept Tied to Birth Defects

  Scott Kappes | October 30, 2007 2:28 PM | 0 CommentsHouston, TX

  The FDA issue a warning to healthcare professionals on Monday about elevated risks of birth defects associated with the drug CellCept. The drug is used as anti-rejection aid for patients that have received transplants. The FDA warns of concerns of an increased likelihood of miscarriage in the first trimester of pregnancy and the risk of severe birth defects during fetal development. The FDA has...

• Birth Defects Attributed to CellCept

  Scott Kappes | October 30, 2007 1:41 PM | 0 CommentsGalveston Bay, TX

  Yesterday the FDA announced warning label changes for anti-rejection medication, CellCept, used after organ transplants. The new boxed warning claims that the drug may pose a significant risk to pregnant women. The drug can be associated with an increased risk of pregnancy loss within the first trimester and increased risk of abnormalities and birth defects. The FDA warns of many possible...

• Avandia Stays on Market--Barely

  Joe Saunders | October 30, 2007 10:59 AM | 0 CommentsPinellas, FL

  In an 8-7 vote, an internal FDA review board voted to allow Avandia to stay on the market. The vote was so close it has drawn scrutiny and criticism from Senator Charles Grassley of the Senate Finance Committee. Grassley criticized the FDA for not making public the findings of the FDA review board. Avandia, a diabetes drug, has been linked to an increase in heart attacks. Avandia already...

• John Edwards' Plan Concerning New Drugs a Step in the Right Direction

  Joe Saunders | October 29, 2007 7:13 PM | 0 CommentsPinellas, FL

  Presidential candidate John Edwards is proposing that pharmaceutical companies refrain from marketing new drug products for two years. This would give the FDA and health officials the necessary time to evaluate and monitor the safety and effectiveness of the drugs. It's also an acknowledgment that big pharma's overly aggressive marketing campaigns translates into huge sales for the...

• Generic for Wellbutrin Under FDA Investigation

  Joe Saunders | October 27, 2007 10:42 AM | 0 CommentsPinellas, FL

  The generic for the popular anti-depressant Wellbutrin XL is under investigation by the FDA after consumers complained of severe headaches, anxiety, insomnia and digestive ailments. The generic Budeprion XL was approved for use in 2006. A consumer products advocacy group ConsumerLab.com began testing the drug after the complaints arose. The tests revealed some differences in the scientific...

• Trasylol Linked to Increased Death Risk

  Joe Saunders | October 26, 2007 8:16 PM | 0 CommentsPinellas, FL

  The FDA has said that Bayer's Trasylol increases the risk of death compared to similar drugs. Trasylol also known as aprotinin, is used in heart bypass surgery to stem excessive bleeding. The drug works by blocking enzymes that dissolve blood clots, hence less bleeding. However, the blood clots are a risk factor for heart attacks and death. Curiously, the FDA has stated a month earlier that...

• Provigil Label Revised

  Jamie G. Goldstein | October 26, 2007 5:44 PM | 0 CommentsChicago, IL

  The FDA is notifying healthcare professionals about updates to the warning labels of the prescription drug Provigil. Provigil is used to help adult patients who suffer from sleep apnea, narcolepsy and other sleeping disorders. The revised label warns patients that Provigil may caused a serious rash that could include Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions. It may also...

• Provigil Gets Additional Warnings

  Scott Kappes | October 25, 2007 4:32 PM | 0 CommentsGalveston Bay, TX

  Yesterday the FDA announced that it would be adding a new warning to Cephalon Inc.'s excessive sleepiness and narcolepsy medication, Provigil, for risk of developing a serious skin rash and psychiatric symptoms. This is the second FDA warning for a Cephalon drug in as many months. Last month "Dear Doctor" letters were sent out regarding the powerful painkiller, Fentora, and its link to four...

• Eli Lilly Pulling the Plug on Blood Thinning Drug Prasugrel

  Joe Saunders | October 25, 2007 8:01 AM | 0 CommentsPinellas, FL

  Until Eli Lilly abruptly pulled patients off of prasugrel, the blood thinning drug had been one of the more promising drugs for the large pharmaceutical company. A. Michael Lincoff, director of cardiovascular research at the Cleveland Clinic, was quoted in the Wall St. Journal as stating that in all likelihood the drug trial was suspended for safety reasons with bleeding the most likely safety...

• FDA Seizes Dietary Supplements at Boca Raton Company

  Joe Saunders | October 24, 2007 10:44 AM | 0 CommentsPinellas, FL

  The FDA has seized $71,000 worth of dietary supplements from FulLife Natural Options, Inc., a company located in Boca Raton, Florida. The seizure highlighted the FDA's efforts to curb the misbranding, mislabeling of dietary supplements that claim to cure medical diseases such as diabetes, hypertension, and anemia. The seized products include Charantea Ampalaya Capsules and Charantea Ampalaya...