FDA & Prescription Drugs

• Avandia Dropped By Two Healthcare Providers

  Scott Kappes | December 07, 2007 11:59 AM | 0 CommentsHouston, TX

  On Thursday two pharmacy benefit programs dropped Avandia from their formularies. The controversial move comes in response to safety concerns stemming from a May report linking the drug to a 43 percent increased risk of heart attack. Prime Therapeutics and HealthTrans announced they will no longer allow their customers to purchase Avandia through their programs. The decision is based on careful...

• Chantix May Trigger Manic Episodes

  Scott Kappes | December 06, 2007 11:14 AM | 0 CommentsHouston, TX

  An American Journal of Psychiatry article suggests the smoking cessation drug Chantix may induce manic episodes in patients with bipolar disorder. The article tells the story of a 63 year-old man with a history of bi-polar disorder. The patient had been stable for 5 years while being treated with valproic acid. One week after starting Pfizer's Chantix the man was committed to an inpatient...

• Warning Issued About Bed-Wetting Drug

  Scott Kappes | December 04, 2007 5:47 PM | 0 CommentsHouston, TX

  Today the FDA said the drug, desmopressin, should no longer be used to treat bed-wetting in both children and adults. Reports of seizures and even death have been associated with the drug. Several different companies sell Desmopressin in several different combinations from oral to injectable. Sanofi-Aventis sell several versions under the name DDAVP. The drug limits the amount of water that's...

• FDA Considers Allowing Off-Label Promotion

  Scott Kappes | December 03, 2007 4:16 PM | 0 CommentsHouston, TX

  Reports have surfaced alleging that the FDA may be considering allowing pharmaceutical companies to market their drugs for uses other than those the drug was approved by the FDA to treat. This is known as off-label promotion. Doctors are allowed to prescribe a drug for whatever purpose they see fit; however, drug companies are not allowed to market drugs for treatments the drug was not approved...

• Myfortic Birth Defect Risk Confirmed

  Scott Kappes | November 27, 2007 5:24 PM | 0 CommentsHouston, TX

  Today the FDA and drug maker Norvitas announced the transplant anti-rejection drug Myfortic has been confirmed to increase the risk of pregnancy loss and congenital malformations. Any patient that is or plans on becoming pregnant should not use Myfortic unless there is no other alternative for treatment. Myfortic has been placed in Category D, meaning there is positive evidence of fetal risk....

• FDA Warns of Potential Harm From Eyelash Enhancers

  Scott Kappes | November 26, 2007 5:00 PM | 0 CommentsHouston, TX

  The FDA has seized more than $2 million worth of what they characterize as an "unapproved and misbranded drug" that claims to lengthen eyelashes. The Age Intervention Eyelash, produced by Jan Marini Skin Research, contains bimatoprost, an ingredient in the popular glaucoma medication Lumigan. Lumigan has been seen to lengthen eyelashes in glaucoma patients an many cosmetic companies are...

• Safety of Advair in Children Being Evaluated

  Scott Kappes | November 26, 2007 9:47 AM | 0 CommentsHouston, TX

  British drug maker GlaxoSmithKline is under fire again, this time concerning the safety of popular asthma medications Advair and Serevent. The top-selling drugs have been blockbusters for GSK, with Advair alone accounting for almost seven billion in sales in 2006. Concerns about the drugs' safety stem from reports of rare and potentially life-threatening side effects in children under the age of...

• Chantix Side Effects Being Investigated by FDA

  Scott Kappes | November 21, 2007 12:18 PM | 0 CommentsHouston, TX

  Yesterday the FDA published an article on their website informing the public and physicians that they are currently reviewing the smoking cessation drug Chantix. The FDA says that they have received reports of erratic behavior and suicidal thoughts from Chantix users. The manufacturer, Pfizer, has submitted postmarketing cases of suicidal ideation and behavior. Preliminary observations reveal...

• Setback for Celebrex Plaintiffs

  Scott Kappes | November 20, 2007 1:29 PM | 0 CommentsHouston, TX

  Pfizer is breathing a big sigh of relief as a federal judge in San Francisco ruled yesterday that plaintiff's attorneys have not produced reliable evidence that 200mg dosage of the painkiller Celebrex caused heart attacks or strokes. It is currently unclear how many of the 3,000 claims against Pfizer involved the 200mg medium dosage. Regardless how much of dent this places in the legal headaches...

• Diabetes Drug Gets Stronger Warning

  Scott Kappes | November 16, 2007 4:11 PM | 0 CommentsHouston, TX

  The once blockbuster drug Avandia has been at the center of controversy over the past several months. In May of this year an article was published in the New England Journal of Medicine linking the drug to a 43 percent increased risk of heart attack. The article was based on an analysis of 42 studies that suggested the possible increased risk. Wednesday the FDA added an additional "black box"...