FDA & Prescription Drugs

• FDA Warning Regarding Use of Byetta

  Brenda Fulmer | November 07, 2007 2:15 PM | 0 CommentsTampa Bay, FL

  The Food and Drug Administration recently issued a warning directed to healthcare professionals regarding Byetta (also known as exenatide), a medication used to treat individuals with type 2 diabetes produced by the pancreas and glucose made by the liver. There have been several reports of acute pancreatitis in patients who were taking Byetta. Several of the patients required hospitalization...

• Novartis' Diabetes Drug Galvus

  Joe Saunders | November 07, 2007 10:42 AM | 0 CommentsTampa Bay, FL

  Novartis AG has decided to delay it diabetes drug Galvus because of concerns with liver toxicity problems. The drug is supposed to compete favorably with Merck's diabetes drug Januvia but problems with high dosage of Galvus has forced its delay to the market. Januvia is a once daily diabetes drug that works in a similar fashion to Galvus but doesn't have the same liver toxicity concerns as...

• Bayer Stops Selling Trasylol

  Joe Saunders | November 05, 2007 9:30 AM | 0 CommentsTampa Bay, FL

  Succumbing to pressure from industry regulators as well as mounting scientific data, Bayer AG has suspended sale of its antibleeding drug Traylol. The evidence has pointed to a greater than acceptable risk of death as a result of using the drug during heart transplant surgery. Safety issues for the drug began to surface in January 2006 when a report in the New England Journal of Medicine...

• Cholesterol Drug Linked to Liver Problems

  Joe Saunders | October 31, 2007 9:44 AM | 0 CommentsTampa Bay, FL

  Japan's Takeda Pharmaceutical Co. is suspending clinical trials of its anti-cholesterol drug known as TAK-475 because of potential side effects concerning the liver. The news comes in the wake of Congressional hearings investigating the FDA's role in monitoring and evaluating pharmaceutical products. One interesting twist thus far in the hearings is how the FDA is supposed to monitor foreign...

• Avandia Stays on Market--Barely

  Joe Saunders | October 30, 2007 10:59 AM | 0 CommentsTampa Bay, 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 CommentsTampa Bay, 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 CommentsTampa Bay, 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 CommentsTampa Bay, 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...

• Eli Lilly Pulling the Plug on Blood Thinning Drug Prasugrel

  Joe Saunders | October 25, 2007 8:01 AM | 0 CommentsTampa Bay, 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 CommentsTampa Bay, 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...