VISIT OUR UPDATED SITE AT 

WWW.PHARMAWATCHDOG.COM

SEE YOU THERE!

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA’s “Early Communication about an Ongoing Safety Review” for Agency recommendations and additional information for healthcare professionals.

Dr. Robert Jarvik is best known for the artificial heart he pioneered more than a quarter-century ago. Since then he had toiled in relative obscurity — until he began appearing in television ads two years ago for the Pfizer cholesterol drug Lipitor.

The ads have depicted him, among other outdoorsy pursuits, rowing a one-man racing shell swiftly across a mountain lake. “When diet and exercise aren’t enough, adding Lipitor significantly lowers cholesterol,” Dr. Jarvik says in the ad.

Celebrity advertising endorsements are nothing new, of course. But the Lipitor campaign is a rare instance of a well-known doctor’s endorsing a drug in advertising — and it has helped rekindle a smoldering debate over whether it is appropriate to aim ads for prescription drugs directly at consumers.

Learn More:  New York Times

FDA announced its intention to take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form.

Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate.

Statement of CSPI Food Safety Director Caroline Smith DeWaal

Following a year when the FDA’s food program was characterized as “high risk” by the Government Accountability Office and cited by FDA’s own Science Board as an agency that “does not have the capacity to ensure the safety of food for the nation,” the Bush Administration’s “food protection” initiative is little more than shadow boxing against unsafe imports. A $32 million increase proposed for fiscal year 2009 for the agency’s food science and inspection programs translates into a bare-bones increase of only $2 million when adjusted for the agency’s typical inflationary cost (6 percent). And while food safety is highlighted as an important area, if the agency has shortfalls elsewhere, it will likely move this money from foods to drugs or devices. The 2009 President’s budget fails to reverse the history of starving this critical public health agency of essential resources.

Pharmagossip is a great resource for inside information about the pharmaceutical industry. The blog is well researched, interesting and Jack, the author, is a good person. I encourage all my readers to check out his site.

Many new drugs initially enjoy banner sales growth, only to get kneecapped by reports of previously unknown adverse side effects. On Friday, the FDA issued an alert “highlighting” a stricter warning label for one of Pfizer’s most important new drugs.

The compound in question, Chantix, is one of the most recent non-nicotine stop-smoking treatments on the market. The FDA approved it back in 2006, but after its launch, some of the more than 5 million patients who have tried the drug began to report adverse events, including anxiety, other serious psychiatric changes, and “vivid” and “unusual” dreams. As a result of these reports, Pfizer strengthened the warning label for Chantix. Last week’s FDA announcement formalized more specific safety warnings for the drug’s label.

Learn More: Motley Fool

Self-expanding plastic stents used to treat benign esophageal disease do not result in long-term alleviation of symptoms, researchers here said.

What’s more, the devices migrated from their initial placement more than 60% of the time, according to Todd Baron, M.D., and colleagues at the Mayo Clinic reported in the January issue of Gastrointestinal Endoscopy.

The findings, based on a retrospective single-institution analysis, appear to contradict earlier studies that showed that the devices stayed put and resulted in improvements in symptoms, the researchers said.

Learn More:  MedPage Today

Our government and big pharma = perfect together.

The government has published guidance promoting partnerships between the National Health Service and the pharmaceutical industry, in a new tactic to improve patient care and help the service meet the rapidly changing demands of the 21st century.

Given its extensive knowledge on illnesses and innovative medicines, the industry certainly has a lot to offer the health service in terms of helping to boost patient care, and the government is hoping that the NHS will tap into this rich source of expertise to put in place a variety of locally tailored healthcare initiatives.

Learn More:  PharmaTimes 

Nursing education fails to prepare graduates to deal with the pharmaceutical industry’s promotional tactics, and many nurses appear to accept promotional materials uncritically, according to an analysis of the nursing literature published in PLoS Medicine.

“The pharmaceutical industry recognizes nursing influence on medical prescribing and identifies nurses as a marketing target,” say the authors, Annemarie Jutel (Otago Polytechnic, Dunedin, New Zealand) and David Menkes (University of Auckland, Hamilton, New Zealand). “The industry has had its eye on nurses and nurse practitioners for over a decade, and is heavily invested in wooing them.”

Learn More:  Medical News Today