Zicam customers have spoken…

June 17th, 2009. By AbiK

But are they smelling? While there’s still a lot on the Zicam FDA warning that needs to play out, truly, a Zicam picture is worth a thousand words. This one taken right from the customer testimonial page on the Zicam website can only be described as…ironic, no?

Hydroxycut Class Action Filed in California

June 17th, 2009. By admin

Here’s one that just came flying across my virtual desk—yes, it does happen to be from a law firm that advertises on LawyersandSettlements.com, but given that Hydroxycut Diet Supplements were touted as “America’s #1 Selling Weight Loss Product” (right on the package!), it does make you wonder about the extent to which adverse effects with Hydroxycut have been underreported. Here’s the release…

Baum, Hedlund, Aristei & Goldman Files National Hydroxycut Consumer Fraud Class Action Lawsuit on Behalf of Millions Who Consumed the Recalled Weight Loss Supplement

LOS ANGELES– Recalled Hydroxycut products are defective and dangerous according to a lawsuit filed today by Baum, Hedlund, Aristei & Goldman in federal court in Los Angeles on behalf of everyone who consumed any of the recalled weight loss Hydroxycut supplements.

The lead plaintiff in this class action, Marvin Thomas of Los Angeles, is seeking compensatory, equitable, declaratory, and injunctive relief for himself and everyone in the Hydroxycut class against the defendants for, among other things, violations of various states’ deceptive trade practices acts, misrepresentation, fraudulent, false and misleading advertisements, and unjust enrichment by distributing a product about which they had been making unsubstantiated claims of safety and effectiveness.

Free Travel for Military Personnel with Prescribing Power

June 17th, 2009. By Evelyn Pringle

From 1998 through 2007, there were 8,700 trips by Department of Defense personnel paid for by the healthcare industry, with a price tag of more than $10 million, according to a new report titled, “Pentagon Travel,” by the Center for Public Integrity.

In a joint project with Northwestern University’s Medill School of Journalism, the Center reviewed travel disclosure forms filed by DOD personnel, and found the medical industry was the largest sponsor of free travel, accounting for about 40% of all trips.

The sponsors included drug and device makers as well as health foundations and trade groups often funded by those companies.

“Drug companies and device manufacturers spent about $1.7 million for more than 1,400 trips taken by DOD doctors, medical researchers, pharmacists, and other health care employees over the decade, creating relationships that pose serious conflict of interest issues, according to medical ethics experts,” the Center said in a June 9, 2009 summary of the study on its website titled, “Medical Industry Showers DOD with Free Travel.”

Certain Asthma and Allergy Drugs Get Stiffer Suicide Warning

June 16th, 2009. By Evelyn Pringle

The requirement for a more prominent warning regarding an increased risk of neuropsyhiatric events, including suicide, applies to Singulair (montelukast), and Accolate (zafirlukast), leukotriene receptor antagonists, and Zyflo and Zyflo CR (zileuton), a leukotriene synthesis inhibitor.

The reported neuropsychiatric events “include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor,” the FDA said in a June 12, 2009, statement on its Website.

“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” the FDA states.

“FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling),” the agency notes.

Singulair, Accolate, and Zyflo are approved to treat asthma, and Singulair is also approved to treat allergic rhinitis and prevent exercise induced asthma.

In March 2008, the FDA announced that Singulair may be associated with suicidality and suicide, and subsequently conducted a review of neuropsychiatric events in post marketing reports and clinical trial data submitted by the drug makers.

Events were not found to be common in the clinical trials but the trials were not designed to look for neuropsychiatric events, the FDA said. “Sleep disorders (primarily insomnia) were reported more frequently with all three products compared to placebo,” the agency noted.

AstraZeneca markets Accolate, and Zyflo is made by Cornerstone Therapeutics. Singulair was Merck’s top selling product in 2008, and the sixth top selling drug in the US, with sales of $3.5 billion, according a March 2009 report by IMS Health.

Another Tysabri Patient Diagnosed With Brain Infection

June 15th, 2009. By Evelyn Pringle

On June 12, 2009, Bloomberg News reported that Biogen “said a patient taking its multiple sclerosis drug Tysabri was diagnosed with a life-threatening brain illness, the eighth case reported in the last year.”

The patient was confirmed to have progressive multifocal leukoencephalopathy (PML), on June 10, according to a report Biogen’s Web site.

“PML is a progressive disease of the brain and spinal cord that primarily affects people with weakened immune systems,” according to a report by WebMD Medical News.

“The condition is caused by a virus that destroys the sheath that covers the nerves,” it says. “Symptoms include mental deterioration, vision loss, speech disturbances, and movement abnormalities or paralysis.”

About 400,000 Americans are believed to have MS. It is more common in women than men and usually strikes between the ages of 20 and 50, according to the National Multiple Sclerosis Society. The disease causes the body’s immune system to rebel by attacking, inflaming and damaging its own nerve tissue.

Tysabri is also “approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn’s disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha,” according Biogen’s Website

“Other drugs linked to PML include Roche’s Cellcept, used to prevent transplant rejections; Biogen and Roche’s cancer drug Rituxan; and Genzyme Corp.’s leukemia drug Campath,” according Bloomberg.

Genentech announced the removal of the psoriasis drug Raptiva from the US market on April 9, 2009, because of a link to PML. Since October 2008, three patients were diagnosed with PML and two died, Bloomberg reports.