FDA & Prescription Drugs

• Asthma Drugs Found to Increase Risk of Hospitalization and Death . . . From Asthma!

  Staff Writer | June 14, 2006 8:07 PM | 0 CommentsDenver, CO

  The Washington Post recently reported that a new analysis of 19 studies of long-acting asthma medicines, such as Advair and Servent, shows that the risk of hospitalization and death is substantially increased over those who used placebos. "What we have here is a drug that increases the number of people who will die from the disease it is treating," said lead author Shelley Salpeter of Stanford...

• FDA Urges Halt of Ketek Antibiotic Trials in Children

  Staff Writer | June 14, 2006 8:04 PM | 0 CommentsDenver, CO

  An official within the FDA called for a halt of clinical trials in children of Sanofi-Aventis' antibiotic, Ketek, based on concerns that the drug might be deadly. The drug is being tested on ear infections and tonsillitis in nearly 4,000 infants and children in over a dozen countries, including the U.S., in spite of its having caused liver failure, blurred vision, and loss of consciousness in...

• Zyprexa Litigation

  Staff Writer | June 14, 2006 8:00 PM | 1 CommentDenver, CO

  On June 8th, Judge Weinstein (the federal judge overseeing the Zyprexa litigation and $700 million settlement) issued an order that if claimants in the settlement do not have their claims submitted to the Special Masters with the necessary documents to support their claim "conforming to the guidelines agreed upon in the Final Settlement Protocol" by July 17th, their claims will be deemed...

• Dying Patients have Right to Experimental Drugs

  Staff Writer | June 05, 2006 1:28 PM | 0 CommentsDenver, CO

  A federal appeals court has ruled that, just as terminally ill patients have a right to die and refuse treatment, they also have a right to take all measures available to them to sustain their lives. The court's ruling allows dying patients access to experimental drugs that have passed the first phase of FDA review, which determines whether a product is safe, even prior to full FDA approval.The...

• Pfizer Accused of Unapproved Testing on Children

  Staff Writer | June 04, 2006 1:41 PM | 0 CommentsDenver, CO

  A panel of Nigerian medical experts issued a report concluding that Pfizer, Inc., illegally tested its unapproved drug, Trovan, on children and infants during a 1996 epidemic of deadly meningitis in Kano, Negeria. Pfizer contends that its use of the unapproved drug was purely for philanthropic reasons, but the Nigerian panel called it a "clear case of exploitation of the ignorant," in its...

• Boca Medical Ultilet and Closercare Insulin Syringes Recalled

  Staff Writer | June 03, 2006 1:36 PM | 0 CommentsDenver, CO

  The FDA's Medwatch has issued an alert to consumers and healthcare professionals regarding the expansion of an earlier recall of Ultilet insulin syringes and the additional recall of Closercare insulin syringes because of bacterial contamination with Paenibacillus. This bacteria presents a risk of local infection due to soft tissue injection with a contaminated syringe, and also a risk of...

• Doggy Vioxx is Risky, too

  Staff Writer | June 02, 2006 1:30 PM | 0 CommentsDenver, CO

  Most people are aware by now that Vioxx, a prescription anti-inflammatory manufactured by Merck & Co., has been associated with an increased risk of heart attack and stroke. But few people know that Deramaxx, an anti-inflammatory medication for dogs which is closely related to Vioxx, has been associated with hundreds of deaths in dogs. Recently, The Washington Post reported that more than 350...

• Eye-Infection Cases Have Required Corneal Transplants

  Staff Writer | June 01, 2006 1:22 PM | 0 CommentsDenver, CO

  Thirty-seven of 120 people who experienced a severe fungal infection from using Bausch & Lomb's RuNu with MoistureLoc contact solution have required corneal transplants, according to an article on health.msn.com. That's 31%, and experts expect that the percentage may climb as high as 50 percent. Bausch & Lomb permanently removed the contact solution, which was used by about 2.3 million...

• Merck Admits Data Error on Vioxx

  Staff Writer | May 31, 2006 1:10 PM | 0 CommentsDenver, CO

  According to the New York Times, Merck admitted yesterday that it was in error when it reported in 2005 that Vioxx caused heart problems only after 18 months of continuous use. Scientists outside of Merck said that Merck's admission, along with clinical trials and real-world Vioxx use, supports critics' claims that Vioxx caused heart problems quickly. Merck's admission could undermine one of...

• Bausch & Lomb Fusarium Keratitis Problem Spans Globe

  Staff Writer | May 13, 2006 10:25 PM | 0 CommentsDenver, CO

  The Singapore's Ministry of Health ("MOH") has also been active in investigating claims of Fusarium keratitis resulting from the use of Bausch & Lomb's ReNu with MoistureLoc. As of February 20, 2006, the MOH had found 39 cases that tested positive for Fusarium, and each person had a history of contact lens use. Out of the 39 cases, 34 said that they had used ReNu. The majority of the 39...