FDA & Prescription Drugs

• FDA's Pursuit of Drug Safety an Underfunded Farce

  Peter Wetherall | December 04, 2007 4:33 AM | 0 CommentsLas Vegas, NV

  http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.htmlhttp://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.htmlhttp://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.htmlAccording to an FDA Report on Science and Technology published on December 3, 2007, the FDA is essentially not able to fulfill its mandate of assuring the safety of drugs. ...

• 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...

• Genentech's Move to Restrict Use of Cheaper Avastin Leads to Probe

  Joe Saunders | December 03, 2007 9:30 AM | 0 CommentsSarasota, FL

  Genentech, the maker of Avastin, has sought to restrict access to its cheaper drug Avastin so that health officials will use a more expensive brand has lead to Congressional criticism. The restriction on the eye disease drug has led one US senator to write letters to the Centers for Medicare and Medicaid and the FDA inquiring as to the propriety of Genentech's actions. Senator Kohl of...

• China Working to Clean Up Pharmaceutical Industry

  Joe Saunders | December 03, 2007 9:23 AM | 0 CommentsPinellas, FL

  China's scandal ridden pharmaceutical industry is undergoing a massive clean up effort by China's version of the FDA. China has been plagued by health scares due to bad drugs, false advertising, and unlicensed drug manufacturers. One Chinese health official, Zheng Xiaoyu, was sentenced to death last May for taking bribes. In one case of bad drugs, dozens of people in Panama died as a result...

• FDA Considering Plan for Off Label Drug Use

  Joe Saunders | December 02, 2007 10:47 AM | 0 CommentsPinellas, FL

  The FDA is working on a plan to allow pharmaceutical companies to distribute information to doctors about a drug's off label usage. The information would be stricly monitored and would include articles from scholarly medical journals. However, if the findings from the medical journal are disputed, the contrary evidence would have to be included in the dissemination to doctors. Off label...

• Myfortic Linked to Pregnancy Loss and Congenital Malformations

  Joe Saunders | December 01, 2007 3:12 PM | 0 CommentsPinellas, FL

  The FDA and drug manufacturer Novartis have issued an alert to healthcare professionals about its drug Myfortic. The drug is used to treat patients with kidney transplants but it has been positively linked to pregnancy loss and congenital malformations. The FDA has stated that Myfortic should not be used in female patients who plan on becoming pregnant due to the increased risk of fetal injury...

• FDA Panel Warns Of Provigil Use in Children

  Scott Kappes | November 30, 2007 5:34 PM | 0 CommentsGalveston Bay, TX

  On Wednesday the an FDA panel suggested that Cephalon's sleep disorder drug, Provigil, should care a stricter warning urging doctors not to prescribe the drug to children. The drug is approved to treat various sleep disorders in adults; however, doctors have been frequently prescribing the drug to treat the same disorders in children. The FDA is concerned that this could have serious adverse...

• How Close is Too Close

  Greg Owen | November 30, 2007 2:55 PM | 0 CommentsGlendale, CA

  It has long been believed by many that the Food and Drug Administration (FDA) is much too close to drug companies, which clearly causes a conflict in terms of regulating those companies. To see the extent of the problem, we only need to take a look at Merck's Vioxx catastrophe, were it was revealed by one scientist that he had actually received vailed threats from the FDA regarding the release...

• More Reports of Chantix Negative Effects

  RLF Staff | November 29, 2007 3:27 PM | 0 CommentsDallas, TX

  The Food and Drug Administration announced last they are finally looking into Chantix, a stop smoking medication, to find out how dangerous it might be.Since the report of Carter Albrecht's unusual behavior and death while taking Chantix, hundreds of other Chantix patients have spoken up about the effects they've experienced. Over the last two months, Ryann Rathbone said she has received...

• Advair Gets New Warning for Use by Kids

  Scott Kappes | November 29, 2007 11:33 AM | 0 CommentsGalveston Bay, TX

  Yesterday a panel of outside experts commissioned by the FDA advised the administration that the popular asthma medications Advair and Serevent should carry an additional warning for use in children. The new warning, if accepted by the FDA, will reportedly advise of a potential increased risk of asthma related hospitalization. The panel also said the warning should be more specific for children....