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Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)

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.

Drug Ads Raise Questions for Heart Pioneer

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

Injectable Colchicine (including drugs containing colchicine)

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.

Bush Food Protection Initiative Fails to Nourish a Starving FDA

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.

Introducing Pharmagossip

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.

More on Chantix

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

Plastic Stents for Espohageal Disease Don’t Work

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

New Marketing Opportunity for Big Pharma

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 

Nurses Are “Soft Targets” For Drug Companies’ Promotional Tactics

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 

FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump

FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.

Mystery Disease in Minnesota

I thought this was very interesting and would like to share it with all of you.

If you have to come down with a strange disease, this town of 23,000 on the wide-open prairie in southeastern Minnesota is a pretty good place to be. The Mayo Clinic, famous for diagnosing exotic ailments, owns the local medical center and shares some staff with it. Mayo itself is just 40 miles east in Rochester. And when it comes to investigating mysterious outbreaks, Minnesota has one of the strongest health departments and best-equipped laboratories in the country.

And the disease that confronted doctors at the Austin Medical Center here last fall was strange indeed. Three patients had the same highly unusual set of symptoms: fatigue, pain, weakness, numbness and tingling in the legs and feet.

Learn More:  New York Times 

Federal Grand Jury Probes Merck’s Handling of Vioxx

Merck & Co. is the subject of a federal grand-jury probe into its sales and marketing practices for Vioxx, the painkiller it pulled from the market in 2004, according to a person familiar with the matter.

The health-care-fraud unit of the U.S. Attorney’s Office for the District of Massachusetts is investigating whether Merck promoted Vioxx to health-care professionals for uses other than those approved by government regulators, a practice known as off-label marketing, this person said.

Learn More: Wall Street Journal

Biovail faces U.S. grand jury probe on Cardizem

Biovail Corp said on Friday it is being investigated by a U.S. federal grand jury in Boston in connection with the 2003 commercial launch of its Cardizem LA heart drug, and analysts speculated the probe might delve into whether physicians were paid to prescribe the treatment. The company would not elaborate on the exact nature of the investigation, and officials in Boston would not comment.

“We’re not confirming or denying a grand jury investigation,” said Christina Diiorio-Sterling, a spokeswoman at the United States Attorney’s Office, District of Massachusetts.

Learn More: Reuters 

OR top bench sends $80m, 9-year case back to court

The Oregon Supreme Court has again allowed a huge punitive-damages award against Big Tobacco’s Philip Morris to stand after it was twice rebuffed by the U.S. Supreme Court.

In Mayola Williams v. Philip Morris Inc. (docket# S051805) filed last week, the Oregon SC ruled against the USSC on whether the original trial jury should have received instructions proposed by Philip Morris. It did not address whether jurors could use damages to punish a company for injuries to people who aren’t part of the lawsuit before the court.

Learn More: LegalNewsLine 

FDA Says Stop-Smoking Drug May Pose Psychiatric Risks

The Food and Drug Administration issued a public health advisory about suicidal thinking and other psychiatric conditions in patients taking the smoking cessation drug Chantix, warning that it “may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur.”

Learn More:  Washington Post

China Pesticide-Tainted Dumplings Poison 175 Japanese

Chinese-made dumplings containing pesticides sickened 175 Japanese in a scandal the government says may damage relations with its neighbor, which exported $56.7 billion of food to Japan last year.

Learn More:  Bloomberg.com

Doctor Admits of Leaking Safety Information to GSK

WASHINGTON, Jan. 30 — Citing a bad case of poor judgment, an independent reviewer for the New England Journal of Medicine has conceded that he leaked privileged information to GlaxoSmithKline last May on a meta-analysis that cast the company’s diabetes drug rosiglitazone (Avandia) in a bad light.

Learn More: Medpage Today

More About Contaminated Drugs from China

A contaminated anticancer drug made by one of China’s largest pharmaceutical companies underscores how quality-control problems continue to plague the Chinese drug industry. There is no sign the tainted leukemia drug was exported. But the case provides a cautionary tale as Western pharmaceutical companies start outsourcing some manufacturing to China.

Learn More: Wall Street Journal

Antiepileptic Drugs

FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)

Felbamate (marketed as Felbatol)

Gabapentin (marketed as Neurontin)

Lamotrigine (marketed as Lamictal)

Levetiracetam (marketed as Keppra)

Oxcarbazepine (marketed as Trileptal)

Pregabalin (marketed as Lyrica)

Tiagabine (marketed as Gabitril)

Topiramate (marketed as Topamax)

Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)

Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.