FDA & Prescription Drugs

• Myfortic Linked to Pregnancy Loss and Congenital Malformations

  Joe Saunders | December 01, 2007 3:12 PM | 0 CommentsTampa Bay, 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 Urges New Safety Review for Children's Asthma Drugs

  Joe Saunders | November 26, 2007 8:17 AM | 0 CommentsTampa Bay, FL

  The FDA is recommending additional safety reviews of three children's asthma drugs. The drugs Serevent, Advair, and Foradil are considered beta agonists and are used for long term prevention of asthma. The three drugs drew a black box warning from the FDA last year. According to a Wall St. Journal article, "a safety review conducted by FDA staff found nine adverse-event reports in children...

• Actos Marketed as Safer than Avandia

  Joe Saunders | November 20, 2007 8:04 AM | 0 CommentsTampa Bay, FL

  Takeda Pharmaceutical Co., maker of the diabetes drug Actos, has launched a new marketing campaign designed to take advantage of Avandia's recent woes. In the new print edition advertisements, the marketing execs state that Actos lowers blood sugar without increasing the risk of heart attack. The ad copy cites "studies" to bolster its argument. However, as is often the case, no scientific...

• Senate Finance Committee Says Glaxo Intimidated Drug Expert

  Joe Saunders | November 17, 2007 12:20 PM | 0 CommentsTampa Bay, FL

  According to a Wall St. Journal article, the Senate Finance Committee has found that Glaxo Smith Kline intimidated and coerced a prominent critic of its diabetes drug Avandia so that he would no longer speak critically of the drug. Dr. John Buse, a diabetes expert and professor of medicine at the University of North Carolina, began to criticize the drug in 1999. Buse became concerned over...

• The FDA and the Potential Conflicts of Interest Among Drug Advisors

  Joe Saunders | November 16, 2007 9:29 AM | 0 CommentsTampa Bay, FL

  In a move to make the relationship between the FDA and the outside advisors more transparent, the FDA will require them to disclose potential financial conflicts of interest in writing. In 2006, a study found that a quarter of all experts the FDA relied on for advice on drugs, including whether or not to approve them for public use, had a financial conflict of interest. The proposed changes...

• Avandia Gets Black Box Warning Label

  Shannon Weidemann | November 14, 2007 9:37 PM | 0 CommentsTampa Bay, FL

  The FDA announced today that the diabetes drug Avandia will now carry a black box warning label on the packaging. The black box warning label will state that the risk of heart attack may increase from taking the drug. The FDA notes that the greater risk of a heart attack has not been confirmed by three other studies done on Avandia. Despite this addition to Avandia's black box -- the FDA's...

• Drug Companies Sue Each Other Over Pricing

  Joe Saunders | November 13, 2007 8:08 AM | 0 CommentsTampa Bay, FL

  Glaxo Smith Kline has sued Abbott Laboratories for increasing its AIDS drug Norvir, five-fold. Norvir, approved by the FDA in 1996, is known as a protease inhibitor. Abbott is also being sued by 2 AIDS patients as well as the SEIU Health and Welfare Fund. This suit has been classified as a class action. According to Glaxo, the quintuple increase in drug price undercut Glaxo's Lexiva, another...

• Cephalon Settles for Federal Probe into Its Marketing Practices for $425 Million

  Joe Saunders | November 10, 2007 9:58 AM | 0 CommentsTampa Bay, FL

  Cephalon Inc. has agreed to pay $425 million to end a federal investigation into its marketing practices concerning sleep and pain drugs. It will also have to plead guilty to a misdemeanor charge of violating federal prescription drug laws. Cephalon was sued by the Pennsylvania Turnpike Commission for attempting to delay generic drug competition.For more information on this subject, please...

• Merck Announces Landmark Settlement of Vioxx Claims

  Brenda Fulmer | November 09, 2007 9:26 AM | 0 CommentsTampa Bay, FL

  Putting an end of rumors that have been circulating for the past several weeks, Merck announced on November 9, 2007, that it had reached a proposed settlement agreement valued at $4.85 billion to resolve the Vioxx litigation that has plagued the company for years. As early 2000, reports began to emerge implicating Vioxx as the cause of heart attacks and strokes. After these first reports,...

• Physicians to Implement New Drug Screening Codes in 2008

  Brenda Fulmer | November 07, 2007 2:27 PM | 0 CommentsTampa Bay, FL

  In the United States, nearly twenty million people suffer from substance abuse and addiction, yet more than 95% of patients are unaware of their condition and are therefore not receiving appropriate treatment. As a result of an initiative by the American Medical Association, starting next year, any physician, not just substance abuse specialists such as psychiatrists, will be able to give their...