FDA & Prescription Drugs

• Class I Recall Issued for Digitek Tablets

  Scott Kappes | April 28, 2008 6:36 PM | 12 CommentsHouston, TX

  Today the Actavis Totowa LLC in conjunction with the FDA issued a Class I recall of all Digitek tablets. Digitek is used to treat abnormal heart rhythms and heart failure;...

• Tysabri Linked to Liver Damage

  Scott Kappes | February 29, 2008 10:18 AM | 0 CommentsHouston, TX

  This week federal health officials updated the prescribing information of Tysabri to warn of a possible link to severe and potentially fatal liver damage. Tysabri, used to treat multiple sclerosis, was recently approved to treat Crohn's disease, but now officials say that a patient can begin to experience liver damage within six days of the first dose of the drug. Tysabri was pulled from the...

• Stop Smoking Aid Receives Approval in Japan

  Scott Kappes | January 29, 2008 10:03 AM | 0 CommentsHouston, TX

  Yesterday Pfizer announced that it had received approval from Japan's Ministry of Health, Labor, and Welfare to manufacture and market the popular stop smoking aid known as Chantix in the US. The drug will be marketed as Champix in Japan, as it is in the UK and EU. This will be the first oral smoking cessation aid availible in Japan and Pfizer expects it to be very popular among Japanese smokers...

• FDA Warns of Severe Pain With Osteoporosis Drug

  Scott Kappes | January 07, 2008 5:17 PM | 0 CommentsHouston, TX

  Today the FDA issued a warning of severe pain associated with a class of osteoporosis medicines known as bisphosphonates. This class includes popular medications Fosomax and Actonel. The potential for severe and even incapacitating bone, joint and muscle pain is listed in the prescribing information, but is commonly overlooked because it may occur within days, weeks, or even years after a...

• FDA Considers Allowing Off-Label Promotion

  Scott Kappes | December 03, 2007 4:16 PM | 0 CommentsHouston, TX

  Reports have surfaced alleging that the FDA may be considering allowing pharmaceutical companies to market their drugs for uses other than those the drug was approved by the FDA to treat. This is known as off-label promotion. Doctors are allowed to prescribe a drug for whatever purpose they see fit; however, drug companies are not allowed to market drugs for treatments the drug was not approved...

• Benefits of Drug-Coated Stents Outweigh Risks

  Tiffany Farr | March 23, 2007 12:54 PM | 0 CommentsHouston, TX

  A study released has shown that drug-eluting stents carry a greater risk for blood clots and heart attacks than older metal versions. Though the risk is quite small, drug-coated stents produce a higher risk of blood clots and heartattacks between 12 and 15 months after the stents are implanted.Stents, used to expand arteries cleared of plaque- a process also known as angioplasty, have become a...

• FDA and Pfizer Ignored Doctor’s Concerns Over Chantix

  Scott Kappes | June 12, 2008 6:05 PM | 3 CommentsHouston, TX

  Over the past several months concerns involving the prescription smoking cessation medication Chantix have been mounting. In the last quarter of 2007 the FDA received nearly 1000 reports of...

• Families to Tell Stories of Vaccine-Autism Link

  Scott Kappes | May 13, 2008 4:52 PM | 0 CommentsHouston, TX

  Today a federal court is scheduled to start hearing a case that will for the second time this year have parents telling their stories of how their children developed autism after be vaccinated...

• All Fentanyl Patches Recalled

  Robert Binstock | May 08, 2008 11:06 AM | 1 CommentHouston, TX

  In February of this year Actavis issued a voluntary recall of 14 lots of their popular fentanyl transdermal painkilling patch. The patches are designed to treat chronic pain by slowly...

• Lawmakers Pledge to Raise More Money For Foreign Inspections

  Scott Kappes | May 02, 2008 5:29 PM | 0 CommentsHouston, TX

  After hearing tearful testimony this week of the family members who recently lost loved ones treated with contaminated batches of the popular blood-thinner Heparin. Heparin was recalled in...