FDA & Prescription Drugs

• Ortho Evra Patch Maker Says Blood Clot Risk Doubles with Birth Control Patch

  Joe Saunders | February 17, 2006 8:49 AM | 0 CommentsOrlando, FL

  Women who use the Ortho Evra birth-control patch face twice the risk of developing blood clots as those who take the Pill, the patch's manufacturer said late Thursday, citing recent company-funded research.The finding comes from one of two studies comparing the patch and Pill, said Ortho Women's Health & Urology, maker of the once-a-week patch, based in Raritan, N.J.

• FDA: Certain Parkinson's Drugs Lead to Greater Risk of Gambling

  Joe Saunders | February 15, 2006 8:34 AM | 0 CommentsOrlando, FL

  The FDA is reporting that certain drugs used to treat tremors associated with Parkinson's disease actually increase the risk of pathological gambling. The latest results are consistent with earlier observations and add to evidence that Parkinson's drugs may lead to impulsive behavior as they make up for depleted dopamine, a brain chemical whose deficiency marks the disease. The researchers...

• "Black Box" Drug Warnings Often Ignored by Healthcare Providers

  Joe Saunders | February 14, 2006 2:58 PM | 0 CommentsOrlando, FL

  In a Wall St. Journal article published today, many patients are told to use drugs with black box warning in spite of these drugs being unsuitable for them. A new study of medicines prescribed in the U.S. has found that many patients are told to use drugs with "black box" warnings even though those drugs aren't suitable for their medical needs.In a study to be published in today's Archives of...

• FDA Official Says Vioxx Maker Merck Had Plenty of Time to Warn Patients of Danger

  Joe Saunders | February 12, 2006 3:15 PM | 0 CommentsOrlando, FL

  Merck could have immediately warned Vioxx patients that the drug might cause an increased risk of heart attacks rather than waiting two years before issuing a warning, according to a former FDA official. Richard Kapit said there was plenty of time to alert the public before Richard "Dickie" Irvin began taking Vioxx, which his widow claims caused his fatal heart attack after a month on the drug...

• Health Experts: FDA Oversight Needs to be More Open and Transparent

  Joe Saunders | February 11, 2006 9:56 AM | 0 CommentsOrlando, FL

  The chairman of an outside committee of medical experts that advises the Food and Drug Administration on drug-safety issues said Friday the agency's own drug-safety oversight board needed to be more open and transparent. The chairman of the committee recommended that the FDA add new members to its oversight board.

• FDA Panel Recommends Black Box Warning for Certain ADHD Drugs

  Joe Saunders | February 10, 2006 6:06 AM | 0 CommentsOrlando, FL

  In a surprise move, a Food and Drug Administration advisory committee voted to recommend that stimulant drugs widely prescribed for attention-deficit hyperactivity disorder carry strong "black box" warnings about potential cardiovascular risks.The warning proposed by a member of the committee would say that the drugs have been associated with increases in blood pressure and heart rate, which...

• Propofol Infusion Syndrome and Heart Failure

  Joe Saunders | February 05, 2006 1:28 AM | 0 CommentsOrlando, FL

  Propofol , distributed by Astra Zenica, is used for general anesthesia during surgery, sedation, and reduction of intracranial pressure in head injury patients. Propofol administration has been associated with the development of propofol-infusion syndrome in pediatric and adult patients. The syndrome consists of myocardial failure, metabolic acidosis, rhabdomyolysis, and hyperkalemia developing...

• Big Pharmaceutical Companies

  Joe Saunders | February 02, 2006 8:25 AM | 0 CommentsOrlando, FL

  When the FDA approved new rules making pharmaceutical companies provide clearer labeling and detailed warnings about their drug products, they also slipped in a second rule change that is both ridiculous in its scope and profoundly anti-consumer. This new rule change argues that because the FDA approves drugs before they can be marketed to the general public, only federal courts should hear...

• Doctors Urge Ending Use of Heart Surgery Drug Trasylol

  Joe Saunders | January 29, 2006 11:59 AM | 0 CommentsOrlando, FL

  A drug used worldwide to reduce bleeding during heart surgery can increase the risk of kidney failure, heart attacks and strokes, and should be abandoned, doctors are reporting today. They say other medicines are safer and cheaper, and should be used instead. The drug, aprotinin, is sold under the brand name Trasylol and manufactured by Bayer. The report was published in The New England...

• New England Journal of Medicine Accuses Drug Companies of Hiding Key Data

  Joe Saunders | December 29, 2005 10:59 AM | 0 CommentsOrlando, FL

  According to a study published this week in the New England Journal of Medicine, several major pharmaceuticals are withholding important details about clinical drug trials, despite urging from federal regulators and medical journal editors. The New England Journal of Medicine specifically cites Merck & Co., Pfizer, and Glaxo Smith Kline PLC as obscuring basic information in reporting on trials...