Posts tagged drug products

• Respiratory Inhaler May Pose Greater Stroke Risk

  Joe Saunders | March 19, 2008 9:05 PM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  The FDA is looking into whether Boehringer Ingelheim' respiratory inhaler poses a greater risk of stroke. According to the FDA, the data submitted by the German drug manufacturer, shows that its Spiriva Handihaler poses a greater risk of stroke compared with a placebo. FDA said it has not yet analyzed the figures, which were compiled from 29 patient studies. The FDA has asked doctors to report...

• FDA Issues Warning on Use of Tussionex

  Sandy Grinnell | March 12, 2008 5:11 AM | 0 CommentsOrlando, FL Category: FDA & Prescription Drugs
  

  Tussionex Pennkinetic Extended-Release Suspension is an often prescribed childrens cough suppressant that contains hydrocodone and the extened release antihistamine chlorpheniramine. The Food and Drug Administration has issued this warning because the medication is improperly being used on patients younger than 6 years old, and is being prescribed and administered more frequently than the...

• Heparin Recalled by Baxter Healthcare

  Ed Normand | March 07, 2008 6:24 PM | 0 CommentsOrlando, FL Category: FDA & Prescription Drugs
  

  Heparin sodium is medication used to thin the blood. It is often administered intravenously. It is used with patients that need kidney dialysis, many types of cardiac surgery, and many other conditions often those involving risk of blood clots. Severe injuries have been reported with this drug recently. The adverse events usually started within minutes of the administration of the ...

• FDA Warning - Internet Sales of Bogus STD Preventatives

  Sandy Grinnell | March 06, 2008 5:28 PM | 0 CommentsOrlando, FL Category: FDA & Prescription Drugs
  

  The FDA issued an emergency alert today warning consumers of drugs being sold on the Internet falsely claiming that they can prevent or treat sexually transmitted diseases. The products are sold under the names of Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus and make claims such as:"Treatment Kills all Herpes Viruses WITHOUT having to use...

• Direct-to-Consumer Advertising by Drug Companies

  Jim Clark | March 06, 2008 3:36 PM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  The idea of drug companies advertising the prescription medicines they manufacture on TV and in other consumer directed media has always been offensive to me. I have often wondered if other consumers like me consider the fact that the drug products these companies advertise are for conditions that never go away. In other words, with few exceptions the products do not heal anything, they just...

• Heparin Finger Pointing Has Already Started

  Brenda Fulmer | March 06, 2008 8:01 AM | 0 CommentsPinellas, FL Category: Defective & Dangerous Products
  

  "A series of independent assessments, inlcuding one by the agency's own Science Board, have found that the F.D.A. is increasingly overwhelmed by its many responsibilties and is incapable of protecting the public from unsafe drugs, medical devices and food - particularly from China." While the Food & Drug Administration continues its investigation into contaminated Heparin blood thinner...

• FDA Early Communication Regarding Botox and Botox Cosmetic

  Sandy Grinnell | February 09, 2008 7:14 AM | 0 CommentsOrlando, FL Category: FDA & Prescription Drugs
  

  The FDA reported today it is performing a "safety review" of Botox and Botox Cosmetic. The review is a result of adverse reactions reported when both A and B types of botulinum toxins were used for injections approved by the FDA and one that has not been approved by the FDA. The FDA has approved Botox to treat spasms in the neck or eyelids and to reduce excess sweating; Botox Cosmetic to...

• Little Recourse for Patients Injured in Drug Trials

  Mike Damaso | February 06, 2008 5:08 AM | 0 CommentsOrlando, FL Category: FDA & Prescription Drugs
  

  There was an interesting article in the Wall Street Journal this weekend regarding the problem of patients injured by new drugs during clinical trials having little to no recourse. The article blames the problem on several factors including: 1. Confusing and vague consent forms; 2. Lack of clarity as to which research entity is responsible for subsequent care; 3. Uncertainty as to how much...

• FDA issues public health advisory on Chantix

  Brenda Fulmer | February 05, 2008 9:23 AM | 0 CommentsPinellas, FL Category: FDA & Prescription Drugs
  

  On February 1, 2008, the FDA issued a public heath advisory (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html) regarding new safety warnings regarding the smoking-cessation drug Chantix (varenicline) indicating, "It appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms." Chantix, a non-nicotine prescription medication...

• Ketek Investigation Continues

  Robert Blanchard | January 30, 2008 9:04 AM | 0 CommentsPensacola, FL Category: FDA & Prescription Drugs
  

  Democrats have now subpoenaed workers in the FDA to determine how in the world they approved Ketek despite scientific concerns over its safety. The new antibiotic ended up killing people from liver damage. Turns out the clinical trials were falsified and at least one doctor has gone to prison. Still no one at Aventis or the FDA has yet to be punished, so well intentioned lawmakers are at least...