FDA & Prescription Drugs

• Parkinson's Drugs Found to Harm Heart Valves

  Staff Writer | January 10, 2007 2:53 PM | 0 CommentsDenver, CO

  A recent study by Italian researches found that about one-fourth of patients taking pergolide (Permax) or cabergoline (Dostinex) had moderate to severe heart valve problems. Another study by German doctors found that people using either drug were five to seven times more likely to develop leaky heart valves than those using other types of Parkinson's medications. "This is an extraordinarily...

• FDA Panel Recommends Approval of Celebrex for Children Despite Safety Concerns

  Staff Writer | December 28, 2006 5:35 PM | 0 CommentsDenver, CO

  An FDA Advisory Committee has recommended that Pfizer be allowed to market Celebrex to children ages 2 and older who suffer from Juvenile Rheumatoid Arthritis (JRA). The panel voted 15-1 that the drug was an effective treatment and that its benefits outweighed its risks. The panel members split on the issue of safety, voting 8-7 (with one abstention) that available data does not demonstrate...

• FDA Advisory Committee Recommends New Limits and Warnings for Ketek

  Staff Writer | December 27, 2006 5:33 PM | 0 CommentsDenver, CO

  Two FDA advisory committees agreed on December 15, 2006, that the antibiotic Ketek (telithromycin) should have new black box warnings added to its label about several serious side effects which have been associated with it. "Black box" is the strongest warning the FDA can mandate. Further, the committees recommended that Ketek be limited to second-line therapy for community-acquired pneumonia...

• Alcohol May Aid in the Survival of Head Injuries

  Staff Writer | December 26, 2006 5:29 PM | 0 CommentsDenver, CO

  Although alcohol consumption is the cause of over 30% of traumatic brain injuries (TBI's), a new study indicates that low to moderate blood alcohol levels may decrease the chance of death after a head trauma. The study published today in the Archives of Surgery show results that link low to moderate levels of alcohol to TBI recovery. TBI patients with high levels of alcohol are more likely to...

• Alzheimer's Drug May Help with Memory Loss Resulting from Traumatic Brain Injuries

  Staff Writer | December 26, 2006 5:26 PM | 0 CommentsDenver, CO

  Traumatic brain injuries (TBI's) are among the most common brain disorders in the US. TBI's occur when a sudden force makes contact with the head and causes damage to the brain. Every year, nearly 1.5 million Americans suffer from a TBI. Memory loss is the most common injury sustained after a TBI and currently over 5 million Americans are living with some sort of memory loss linked to a TBI....

• Merck wins Alabama Vioxx verdict

  Staff Writer | December 18, 2006 2:02 PM | 0 CommentsDenver, CO

  Vioxx manufacturer Merck & Co. experienced a courtroom victory last week in Alabama. The jury in the product liability trial found that the Vioxx makers did not hide the serious risks associated with the drug in the case of a man who accused the company of causing his heart attack. CNNMoney.com reports on the verdict:"This plaintiff did have many pre-existing risk factors" and the heart attack...

• Elidel and Protopic Label Warnings

  Staff Writer | December 15, 2006 10:30 AM | 0 CommentsDenver, CO

  On January 19, 2006 the FDA approved an updated label for Elidel and Protopic. Elidel and Protopic are drugs used to treat atopic dermatitis. Both drugs are calcineurin inhibitor drugs that are used topically to target cells that cause atopic dermatitis in patients. More commonly known as eczema, atopic dermatitis is a non-life-threatening skin condition that causes dry, scaly skin and severe...

• Anemia Drugs Associated with Higher Risk of Death, Heart Attack and Stroke

  Staff Writer | December 08, 2006 6:06 PM | 0 CommentsDenver, CO

  Three anemia drugs were the subject of a recent study published in the New England Journal of Medicine which concluded that there was a higher chance of death, heart attack, hospitalizations for heart failure and stroke in patients with chronic kidney disease who are not on dialysis and were treated with Procrit to raise their hemoglobin levels higher than what the labeling for the product...

• Paxil and Other Antidepressants Associated with Birth Defects

  Staff Writer | December 05, 2006 1:04 PM | 0 CommentsDenver, CO

  The American College of Obstetricians and Gynecologists (ACOG) has recently published an opinion regarding the use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for treatment of depression during pregnancy. ACOG warns that a particular SSRI known as Paxil (generic: paroxetine) should be avoided when possible by pregnant women or women who...

• FDA Reports New Cases of Rare Neurological Disorder After Administration of Vaccine(2)

  Staff Writer | November 22, 2006 4:06 PM | 0 CommentsDenver, CO

  The FDA and CDC have updated an alert issued last year after receiving more reports of a rare neurological disorder, Guillain Barre Syndrome (GBS) following administration of a vaccine (trade name Menactra) designed to prevent meningococcal disease, a major cause of bacterial meningitis and blood stream infections.To date, a total of 15 confirmed cases of GBS have been reported among individuals...