FDA & Prescription Drugs

• Vioxx Settlement Could Be Problematic for Some

  Scott Kappes | November 19, 2007 3:58 PM | 0 CommentsGalveston Bay, TX

  An agreement was reached to settle the overwhelming majority of cases resulting from injuries related to Vioxx. Many have carefully examined wording of the agreement and it seems that Merck may have ended up in a better position than once speculated. The $4.85 billion deal includes a peculiar provision that says if a lawyer has one client enroll in the deal, the attorney must recommend the deal...

• Avandia Gets New Warning

  Scott Kappes | November 16, 2007 11:51 AM | 0 CommentsGalveston Bay, TX

  On Wednesday the FDA announced that the type-2 diabetes drug Avandia would now carry a additional "black box" warning. The "black box" warning is the strictest label that can the FDA can place on a medication. The new warning will cite a May New England Journal of Medicine article that demonstrated a possible link between Avandia and an increased risk in heart attack. The warning does not...

• Adverse Events Continue with Chantix

  Scott Kappes | November 14, 2007 9:56 AM | 0 CommentsGalveston Bay, TX

  Just over a year ago pharmaceutical giant Pfizer introduced a revolutionary smoking cessasation drug to the market. This drug, called Chantix, work differently than stop smoking aids in the past. Chantix actually blocks nicotine receptors in the brain, eliminating the satisfaction induced by nicotine consumption therefore eliminating the urge to smoke. Over 4 million people have tried Chantix...

• St. Jude Lead May Puncture Heart

  Scott Kappes | November 13, 2007 4:36 PM | 0 CommentsGalveston Bay, TX

  Monday a medical journal published findings suggesting that St. Jude's defibrillator leads may puncture the heart on rare occasions. Four cases were highlighted Monday's PACE Journal publication. The cases in question involve St. Jude's Riata leads; two cases were reported in the Czech Republic and two more in the United States. A 71-year-old New York woman's Riata lead came within a quarter of...

• Merck Settles Vioxx Suits

  Scott Kappes | November 09, 2007 12:05 PM | 0 CommentsGalveston Bay, TX

  Today Merck & Co. announced that they will pay $4.85 billion to settle the thousands of Vioxx suits. This is not a class action settlement. Merck will place the money in a fund and those who claim to have been injured by the drug will be able to petition for the money. They say that each individual case will be assessed before payment is made. Merck had previously claimed that they fight every...

• Drug Company Raided By Feds

  Scott Kappes | November 02, 2007 11:50 AM | 0 CommentsGalveston Bay, TX

  Yesterday federal agents raided a St. Louis drug company after being tipped off that the company was hiding drug products behind a fictitious walls and manufacturing medications under unsanitary conditions. The company, General Therapeutics Corp., produces over the counter medications for both humans and animals, dietary supplements, vitamins, and NC solution. Agents from the FDA and the U.S....

• 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...

• 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...

• Byetta Cited by FDA for Pancreatitis Risk

  Scott Kappes | October 22, 2007 2:53 PM | 0 CommentsGalveston Bay, TX

  The popular type-2 diabetes medication, Byetta, has been linked to acute pancreatitis after a review of 30 postmarketing reports. The FDA suspects an association between Byetta and acute pancreatitis, and has recommended labeling changes to warn patients and physicians of the possible danger. Manufacturer, Amylin Pharmaceuticals, Inc. has agreed to include the proposed changes regarding acute...

• Zyprexa Gets Stronger Warnings

  Scott Kappes | October 09, 2007 1:08 PM | 0 CommentsGalveston Bay, TX

  Last Friday Eli Lilly and Co. announced that they will be pumping up the warnings on the anti-psychotic drug Zyprexa. Zyprexa is used to treat schizophrenia and bipolar disorder. The drug has been seen to induce weight gain, increase blood sugar levels and cholesterol among other concerns. The new warnings will give a more accurate representation of these potential risks associated with the use...