FDA & Prescription Drugs

• Lamactal May Cause Cleft Lip or Palate Says FDA

  Lee Coleman | October 02, 2006 11:16 AM | 0 CommentsBowling Green, KY

  The FDA said that Lamictal used for seizures or bipolar disorder, if used during the first 3 months of pregnancy may cause cleft lip or cleft palate. Cleft lip and/or cleft palate are anomalies that occur when a baby's lip and/or palate do not fully form prior to birth. A cleft lip is a separation of the two sides of the upper lip. The separation often includes the gum line and/or bones of the...

• Avastin Can Cause RPLS and Nasal Septum Perforation

  Lee Coleman | September 26, 2006 11:37 AM | 0 CommentsBowling Green, KY

  The FDA and Genetech notified healthcare professionals about revisions to the warnings and adverse reaction sections of the prescribing information on Avastin about cases of a rare brain-capillary leak syndrome called (RPLS) reversible posterior leukoencephalopathy syndrome and reports of nasal septum perforation. "RPLS is a neurological disorder associated with hypertension, fluid retention and...

• Vioxx-Like Risk Linked to Diclofenac

  Lee Coleman | September 14, 2006 12:30 PM | 0 CommentsBowling Green, KY

  A report released by the Journal of the American Medical Assn says that Diclofenac, also known as Cataflam or Voltaren, increased patient's chance of heart attack by 40% according to an analysis of 23 clinical studies, the same risk observed in patients who took low doses of Vioxx. The FDA is calling for further review.Diclofenac, which has been sold for more than 30 years, is available only by...

• Merck Admits 18-Month Vioxx Claim Doesn't Hold Water

  Staff Writer | June 01, 2006 3:53 PM | 0 CommentsBowling Green, KY

  The Wall Street Journal Law Blogs section reported yesterday that Merck admitted its contention that Vioxx users' heart attack and stroke risks were elevated only after 18 months of use cannot be supported byt the study which the company originally used to support that claim.The drug maker has contended that the study shows an increased risk of heart attacks and strokes only for patients taking...