FDA & Prescription Drugs

• Therapeutic Vaccines

  Staff Writer | February 14, 2006 1:10 PM | 0 CommentsDenver, CO

  There is an interesting article on the promises of therapeutic vaccines at www.pharmaceutical-business-review.comAfter defining therapeutic vaccines, the article states that vaccine development is presently weighted towards cancer vaccines then outlines a history of failures in the vaccine industry. The author identifies two basic types of therapeutic vaccines described as personalized or...

• Doctors Back Ban on Gifts From Drug Makers

  Staff Writer | February 14, 2006 12:06 PM | 0 CommentsDenver, CO

  In the January 25 issue of the Journal of the American Medical Association, a group of influential doctors supports the banning of gifts, drugs and continuing education provided to medical professionals by pharmaceutical companies. The doctors claim that accepting these perks undermines patient care.According to Federal regulations, companies are not allowed to pay medical professionals to...

• FDA Issues Public Health Advisory for Trasylol

  Robert Blanchard | February 13, 2006 10:05 AM | 0 CommentsPensacola, FL

  The Food and Drug Administration issued a Public Health Advisory alerting doctors who perform heart bypass surgery, and their patients, that Trasyolol (aprotinin injection), a drug used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects including kidney problems, heart attacks and strokes in patients who undergo artery...

• 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.

• Possible Black box warnings and medication guides for ADHD Drugs

  Staff Writer | February 10, 2006 6:20 PM | 0 CommentsDenver, CO

  The FDA Advisory Committee published an alert today regarding possible black box warnings and medication guides for ADHD Drugs.Attention deficit/hyperactivity drugs should be prescribed with a medication guide warning of potential cardiovascular risks with the class of stimulant agents, FDA's Drug Safety & Risk Management Advisory Committee recommended Feb. 9.FDA conducted an analysis of adverse...

• 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...

• Attention Deficit Drugs May Be Linked To Deaths

  Bob Carroll | February 10, 2006 4:53 AM | 0 CommentsTampa Bay, FL

  Two articles raise concerns about attention deficit drugs. Both articles are posted below in their entirety in order to assure public awareness of these concerns. The drugs include Ritalin, Concerta, Methylin, Metadate, Adderall and Adderall XR. The drugs may be linked to an increased risk of death and injury. Special warnings on attention deficit drugs urged Associated Press WASHINGTON --...

• ORTHO EVRA BIRTH CONTROL PATCH

  Jeremy Thurman | February 07, 2006 11:22 AM | 0 CommentsNew York City, NY

  The Food and Drug Administration (FDA) announced on November 11, 2005 that the Ortho Evra contraceptive patch exposes millions of women who use the patch to levels of estrogen far higher than most daily birth control pills, putting them at higher risk for blood clots than previously disclosed. The FDA also approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare...

• 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...