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• Bush Requests Increased FDA Funding

  Scott Kappes | June 10, 2008 6:22 PM | 0 CommentsGalveston Bay, TX

  The White House has increased its budget request for the U.S. Food and Drug Administration by a whopping $275 million. The request comes on the heals of a rough year for the FDA that was...

• Lawsuits Filed Over Digitek Recalls

  Scott Kappes | May 09, 2008 5:28 PM | 2 CommentsGalveston Bay, TX

  Two weeks after Actavis issued a recall for its heart medication Digitek, or digoxin, the first lawsuits have been filed. Very little information has been made available on this recall other...

• Fosomax Doubles Atrial Fibrillation Risk

  Scott Kappes | April 29, 2008 3:10 PM | 0 CommentsGalveston Bay, TX

  A new study suggests that women treated with Fosomax to combat the symptoms of osteoporosis are twice as likely to develop a common form of irregular heartbeat known as atrial fibrillation...

• Wrongful Death Lawsuit Filed Over Nuva Ring Contraceptive

  Scott Kappes | March 20, 2008 2:42 PM | 0 CommentsGalveston Bay, TX

  This week a wrongful death lawsuit was filed on behalf of the family of a New Jersey mother of two who tragically died after suffering a seizure on December 7, 2007. Jackie Kelly Bozicev, 32, had recently moved into a new home with her husband, Robert, and two young children Mary Kelly and Matthew. Jackie and Robert planned two have more children in the future, but wanted to hold off for a...

• FDA Panel To Vote On Zyprexa

  Scott Kappes | February 06, 2008 4:03 PM | 0 CommentsGalveston Bay, TX

  Today a panel of outside experts will examine advise the FDA on whether or not a new injectable version of the popular schizophrenia drug, Zyprexa, should be approved in the US. Zyprexa is currently available in a once-daily pill form, but the new formula, Zyprexa Adhera, can be injected into the muscle and last up to four weeks. The panel will weigh all aspects of the drug and available...

• Chantix Gets New Warning For Behavioral Changes

  Scott Kappes | January 18, 2008 1:46 PM | 0 CommentsGalveston Bay, TX

  Today Pfizer announced that the smoking cessation drug Chantix will now carry an additional warning advising doctors to monitor patients for changes in behavior, including but not limited to depressed mood, agitation, suicidal thoughts and suicidal behavior. While no causal relationship has been established between these changes and Chantix; however, Pfizer said a possible link couldn't be ruled...

• FDA Warns Pharmacies About Menopause Drug Claims

  Scott Kappes | January 11, 2008 12:37 PM | 0 CommentsGalveston Bay, TX

  On Wednesday the FDA sent letters to seven pharmacies ordering them to stop making false and misleading claims about custom-made "compounded" hormone products sold over the Internet to treat menopause. Claims that these synthesized hormones are more effective than approved menopause therapies are false according to the FDA and other experts. The FDA said in the letters that the claims made by...

• Chantix Suicidal Ideation Reports Doubled in Two Months

  Scott Kappes | December 14, 2007 1:48 PM | 0 CommentsGalveston Bay, TX

  Over the last few months the troubles for Pfizer's smoking cessation drug, Chantix, have been growing by leaps and bounds. The shooting death of Dallas musician Carter Albrecht sparked public interest here in the U.S. and in the UK and Europe their version of the same drug, marketed as Champix, was thrown into the public eye after the highly publicized suicide of well known television editor...

• 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...

• 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...