FDA & Prescription Drugs

• Hearing Loss Attributed to ED Drugs

  Scott Kappes | October 22, 2007 1:47 PM | 0 CommentsHouston, TX

  The FDA has issued a warning to healthcare professionals and consumers of sudden decreases in hearing and hearing loss associated with certain erectile dysfunction medications. Labeling changes for such blockbuster medications as Viagra, Levitra, and Cialis have already been initiated. The FDA says that the hearing loss can be accompanied by tinnitus, the ringing of the ears, and dizziness....

• Medtronic Defibrillator Leads Recalled

  Scott Kappes | October 18, 2007 1:54 PM | 0 CommentsHouston, TX

  On Monday Medtronic issued a warning about the possible fracture danger associated with a small percentage of defibrillator leads. This warning was accompanied by a voluntary stop in distribution of these allegedly defective leads. Yesterday the company updated the warning and issued a Class I Recall. The recall covers Medtronic Inc Sprint Fidelis Defibrillator Leads manufactured September of...

• Micro-bubble Contrast Agents Linked to 11 Deaths

  Scott Kappes | October 16, 2007 9:13 AM | 0 CommentsHouston, TX

  Friday the FDA announced increased warnings for ultrasound micro-bubble contrast agents after receiving several reports of serious cardiopulmonary reactions and 11 deaths related to the contrast agents. These contrast agents are used in conjunction with an echocardiograph to enhance the image, allowing doctors greater ability to see potentially dangerous cardiovascular conditions. There have...

• Numerous Inquiries About Chantix

  Scott Kappes | October 03, 2007 10:49 AM | 0 CommentsHouston, TX

  I have been writing over Chantix for just about a month now and our law firm has received dozens of inquiries about Chantix form patients claiming bizarre side effects. Just yesterday we were contacted by a couple that took the drug together and both experienced such bad side effects, including but not limited to suicidal ideation, that they had to stop taking the medication. I saw a report...

• Gadolinium Contrast Agents Get "Black Box" Warning

  Scott Kappes | October 01, 2007 10:33 AM | 0 CommentsHouston, TX

  Friday the FDA finalized the its announcement made in May that it would add the "black box" warnings to gadolinium based contrast agents used to enhance magnetic resonance imaging (MRI). These contrast agents have been linked to rare skin disease known as nephrogenic systemic fibrosis (NSF). This is very serious disease characterized by the thickening of the skin and even internal tissue and...

• Federal Advisers say Celebrex for kids: OKAY.

  Allison Snoddy | December 04, 2006 5:48 PM | 0 CommentsHouston, TX

  On November 29, 2006 Federal advisers recommended that Pfizer Inc. can market their painkiller Celebrex to children with rheumatoid arthritis. The Food and drug Administration now is faced with making a decision of whether they will expand the approval of Celebrex.The advisers said that the benefit's outweighed the risks in a 15 to 1 vote. Celebrex is also a Cox 2 inhibitor drug along with...

• Celebrex to be Considered for Use in the Treatment of Juvenile Rheumatoid Arthritis

  Tiffany Farr | December 01, 2006 3:20 PM | 0 CommentsHouston, TX

  On November 29, 2006, an FDA panel voted in favor of approving the Cox-2 inhibitor, Celebrex, for the treatment of juvenile rheumatoid arthritis. Extremely debilitating, juvenile rheumatoid arthritis affects between 30,000 to 60,000 children in the United States alone. To this date, the only medications available to children for this condition were naproxen, ibuprofen, and aspirin.Celebrex, the...

• Selecting Cases for NJ Vioxx Trial

  Allison Snoddy | October 17, 2006 11:03 AM | 0 CommentsHouston, TX

  Last week was the deadline for lawyers representing Plaintiffs in the Vioxx trials to select 10 cases that were to be submitted to Judge Carol Higbee for consideration in the upcoming trials for January. Merck has until today (October 17, 2006) to make any specific objections to plaintiffs chosen by opposing lawyers.Merck can make objections over the prospect of trying plaintiffs from different...

• September 30th Deadline to file Vioxx Claims Rapidly Approaching

  Tracy Beard | September 27, 2006 4:30 PM | 0 CommentsHouston, TX

  The upcoming September 30th deadline to file lawsuits involving Vioxx claims has Texas plaintiffs' firms busy reviewing medical records and preparing for the last minute court filings. Attorneys and support staff in our office are working hard to make contacts and rush orders of pharmacy and medical records to get any viable claims filed before the deadline passes. Texas lawyers, including our...

• Vioxx Labels: Precautions vs. Warnings

  Allison Snoddy | September 11, 2006 4:59 PM | 0 CommentsHouston, TX

  Today, another Vioxx trial has gotten under way in New Orleans. This case differs from the previous ones as the Plaintiff started taking Vioxx after April 2002, the date when Merck added information in the "Precautions" section of the label warning of increased risks for heart attacks and strokes.The major issue is whether Merck should have included this information in the "Warnings" section;...