FDA & Prescription Drugs

• FDA Proposing New Rule For Drug Label Modifications

  Scott Kappes | January 16, 2008 3:47 PM | 0 CommentsGalveston Bay, TX

  A new rule being proposed by the FDA would be welcomed by drug companies and could be a thorn in the side of plaintiffs' lawyers everywhere. The new rule would establish narrow guidelines under which drug companies can make changes to drug labels on their own. It may seem somewhat odd that drug companies would approve a narrowing of guidelines by the FDA, but it makes perfect sense when...

• New Study Questions Vytorin's Efficacy

  Scott Kappes | January 15, 2008 11:55 AM | 0 CommentsGalveston Bay, TX

  A study released yesterday shows evidence that the blockbuster cholesterol medication Vytorin is not anymore effective than generic Zocor. Vytorin, a combination of Zetia and Zocor, is prescribed over 100,000 times each day generating over $5 billion in annual sales for Merck and Schering-Plough. Vytorin was shown to lower bad cholesterol levels better than Zocor alone, but showed no measurable...

• 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...

• Report Puts Excess Avandia Heart Attacks at 83,000

  Scott Kappes | January 10, 2008 12:30 PM | 0 CommentsGalveston Bay, TX

  A November report by the Senate Finance Committee, based on the analysis of a Avandia by FDA scientists, estimates that Avandia has caused around 83,000 excess heart attacks since coming on the market in 1999. The statistics were presented at a July 30, 2007, safety panel meeting of experts to decide if Avandia should remain on the market. The panel did recommend that Avandia Remain on the...

• Drug-maker Faces Class Action Over Zimulti

  Scott Kappes | January 08, 2008 4:38 PM | 0 CommentsGalveston Bay, TX

  A class action lawsuit has been filed against pharmaceutical powerhouse Sanofi-Aventis alleging that the company hid data concerning adverse events associated with their obesity medication Zimulti. The French company allegedly concealed data showing Zimulti's propensity to cause depression. Zimulti has also been shown to increase suicidal ideation and action in some cases. In June the FDA...

• Anti-Psychotic Meds May Not Calm Aggression

  Scott Kappes | January 07, 2008 12:58 PM | 0 CommentsGalveston Bay, TX

  Anti-psychotic medications are only approved by the FDA to treat psychotic symptoms; however, it has become commonplace for health care professionals to use anti-psychotic medications to calm aggressive behavior through off-label use. There has never been any conclusive evidence to show this to be effective method, but a new study may shine a little more light on the issue. An article in the...

• Reich & Binstock Chantix Client In the News

  Scott Kappes | January 02, 2008 5:20 PM | 0 CommentsGalveston Bay, TX

  Last week the CBS evening news featured a story on the possible relationship between Pfizer's smoking cessation drug Chantix and an increased risk of suicide. The story was centered on 33 year-old Amy Garza. Garza claims that shortly after starting Chantix she began to fall into what she described as a "psychotic breakdown." Garza made an attempt to take her own life shortly thereafter. Chantix...

• Quitting With Chantix Could Be Dangerous

  Scott Kappes | January 01, 2008 3:35 PM | 0 CommentsGalveston Bay, TX

  With the New Year upon us millions of people will have made their New Year's resolution to quit smoking. They will seek every avenue available to help them through the quitting process. They will try nicotine patches and gum, and many will opt for Pfizer's Chantix to help them deal with the difficulties associated with quitting smoking. Smokers who decide to use Chantix to help them quit smoking...

• Suicide Warning For Champix

  Scott Kappes | December 18, 2007 10:26 AM | 0 CommentsGalveston Bay, TX

  The European Medicines Agency (EMEA), the European equivalent to the FDA, has decided that new advice is needed to warn both doctors and patients a possible link between Pfizer's stop smoking drug Champix, marketed as Chantix in the U.S., and suicide. The decision has been made to include a warning for depression, suicidal ideation or thoughts, and the possibility of suicide. Australian...

• 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...