FDA & Prescription Drugs

• FDA issues public health advisory on Chantix

  Brenda Fulmer | February 05, 2008 9:23 AM | 0 CommentsTampa Bay, FL

  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...

• Drug Companies Pull Vytorin TV Ad

  Joe Saunders | January 23, 2008 2:20 PM | 0 CommentsTampa Bay, FL

  A week after a study showed that Vytorin is no more effective in reducing cholesterol than the company's generic equivalent, Merck and Schering-Plough withdrew their direct-to-consumer marketing ads. Vytorin, a combination of Zetia and Merck's Zocor, lost patent protection in 2006. The marketing campaign was a familiar one to television viewers and was dubbed "food and family" depicting in a...

• FDA Warns About Anemia Drug Risks

  Joe Saunders | January 08, 2008 11:46 AM | 0 CommentsTampa Bay, FL

  In a new warning about certain anemia drugs, the FDA has noted that studies are showing that patients with breast or advanced cervical cancers died more rapidly or their tumors grew at an advanced rate than those who were not treating with anemia drugs known as ESAs (erythropoiesis-stimulating agents). According to the FDA, "all eight studies show more rapid tumor growth or shortened survival...

• Yet Another Study Confirming That Discontinuation of HRT Led to Drops in Breast Cancer Rates

  Brenda Fulmer | December 31, 2007 3:06 PM | 0 CommentsTampa Bay, FL

  "Reductions in postmenopausal breast cancer incidence observed in the US were strongest in White women, intermediate in Asian/Pacific Islander and Hispanic women, and absent in African-American women. In all groups, declines were most evident for hormone receptor-positive, lobular, and small cancers. While this and other ecologic analyses cannot definitively speak to the influence of...

• FDA Issues Second Warning About Fentanyl Skin Patch

  Joe Saunders | December 22, 2007 1:09 PM | 0 CommentsTampa Bay, FL

  The FDA has issued another warning about the Fentanyl skin patch used to administer powerful pain medication to patients. The problems with the skin patch have occurred due to misprescribing the drug or improper use of the patch resulting in serious injury and death. The skin patch was approved for use by the FDA in 1990 but has resulted in serious health concerns for users of the patch. ...

• CDC Recommends Delaying HIB Booster Shot

  Shannon Weidemann | December 20, 2007 10:45 PM | 0 CommentsTampa Bay, FL

  It was announced last week that 1.2 Million doses of the HIB vaccine were recalled. The recalled vaccine was manufactured in a Pennsylvania plant that was found to be contaminated. The CDC is concerned of a vaccine shortage and urged doctors to delay the third and final booster shot in the series. The vaccine is given to infants to help prevent pneumonia and meningitis. Normally, the...

• Zyprexa on the Verge of Being Marketed to Children

  Joe Saunders | December 16, 2007 11:08 AM | 0 CommentsTampa Bay, FL

  In today's St. Petersburg Times, there is a front page story about Eli Lilly's apparently successful efforts at marketing the drug Zyprexa to children. The FDA is about to approve the drug's use for children in spite of the dangerous side effects which include diabetes. Children are even more susceptible to these side effects. In the article, I am quoted as saying that Eli LIlly isn't fazed...

• FDA Strengthens Warnings on Epilepsy Drugs

  Joe Saunders | December 13, 2007 11:27 AM | 0 CommentsTampa Bay, FL

  The Food and Drug Administration has strengthened already tough warnings on certain epilepsy drugs that are also used to treat bipolar disorder and nerve pain. In addition, the FDA singled out those of Asian ancestry to undergo genetic testing prior to beginning any regimen with the drug carbamazepine which is distributed as Carbatrol by Shire PLC, Tegretol by Novartis AG and Equetro by Validus...

• China Working to Clean Up Pharmaceutical Industry

  Joe Saunders | December 03, 2007 9:23 AM | 0 CommentsTampa Bay, 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 CommentsTampa Bay, 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...