FDA Issues Safety Alert on Diabetes Drug

Diabetes Drug Avandia Raises Risk of Heart Attack, Study Suggests; FDA Issues Safety Alert

The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday.

The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of London.

More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the New England Journal of Medicine.
Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.

The company downplayed the report of heart risks, saying the analysis by Dr. Steven Nissen and statistician Kathy Wolski at the Cleveland Clinic is not definitive scientific proof. In a conference call Monday, Dr. Lawson McCartney who leads Glaxo's diabetes drug development, said the company is not seeing "anything like" the problems reported in the medical journal.
"We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine," McCartney said.

The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research.
Some data suggests "that there is a potentially significant increase in the risk" but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.

FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would hold hearings on the safety issues.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 18 million Americans and 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
Avandia helps sensitize the body to insulin and was considered a breakthrough medication for blood-sugar control.

Worried patients should not quit Avandia on their own and should discuss concerns with their doctors, wrote Drs. Bruce Psaty and Curt Furberg in an editorial in the New England Journal. Psaty is with the University of Washington in Seattle and Furberg is with Wake Forest University.

However, to the extent that the new analysis shows valid risks, the drug "represents a major failure of the drug-use and drug-approval processes in the United States," they said.

When the drug was approved, "evidence was at best mixed" on its benefit, wrote the two doctors. Both have been frequent critics of the FDA's failure to spot dangers in the drug approval process and its conduct in the case involving Vioxx. The popular arthritis medicine sold by Merck & Co. was taken off the market in 2004 when heart problems came to light after it had been taken by millions of people

Several experts said Avandia was another example of the FDA failing to detect a safety problem early enough.

Glaxo's shares trading in the United States fell $3.85, or 6.6 percent, to $53.89 in afternoon trading.

The report on the diabetes drug's risks follow Glaxo's $2.5 million settlement of a lawsuit filed by former New York Attorney General Eliot Spitzer over the release of data on the safety and effectiveness of its drugs. Spitzer, now New York governor, accused Glaxo of fraudulently withholding some results of studies that had examined the safety of prescribing the antidepressant Paxil to children.

Januvia: A new type of Type II diabetes drug

A review of this drug and how it works coming today!

US aims to tighten rules on direct-to-consumer drug ads

With a new Congress controlled by the Democratic Party, the US biotech industry might be facing tighter restrictions on direct-to-consumer (DTC) advertising. This spring, Congress is set to debate measures that include a two-year moratorium on advertising for newly approved products and higher user fees for extra Food and Drug Administration (FDA) staff to monitor television, print and radio advertisements.

The US and New Zealand are the only countries that allow DTC drug advertising, and such ads pumped $4.5 billion into the US media economy in 2006, up from $2.8 billion in 2002, according to the drug and biotech industries.

However, over the past several years—and after the spectacular safety failure in 2004 of a heavily advertised and top-selling drug, the COX-2 inhibitor Vioxx (rofecoxib)—calls have grown louder for more government control.

"The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting...health," says Dominick Frosch, assistant professor of medicine at the University of California, Los Angeles (UCLA). In the January/February issue of the Annals of Family Medicine, Frosch and colleagues published an analysis of television drug ads, concluding that 95% of analyzed ads appealed to emotion and none mentioned lifestyle changes as an alternative to a pill.

Riding a bike in the desert: Flomax

Every male mammal will eventually present with symptoms of an enlarged prostate. Non cancerous prostate enlargement is termed benign prostatic hyperplasia (BPH) and is a common chronic disease, with the incidence of BPH increasing with age.
This enlargement causes partial blockage of the urethra which impedes urinary output and and may lead to obstructive and irritative symptoms. It is caused by enlarged cells and cells that grow to compensate the enlarged cells within the prostate. The growing cells are called smooth muscle cells and have specific receptors on their cell surface that can regulate their rigidness, such that when these receptors are inhibited, they relax. This results in increased flow.

Flomax blocks these receptors and causes increased urinary flow by relaxing enlarged/proliferating smooth muscle cells within the prostate.

In the news today: Combo migraine drug beat single drug therapy

An experimental drug that combines two commonly used treatments helped quell migraine symptoms better than either one alone, a new U.S. study released Tuesday suggested.

The research, published in this week's Journal of the American Medical Association, tested experimental drug combination Trexima against either drug used alone.
Pozen Inc. is developing Trexima with British drugmaker GlaxoSmithKline's. The drug combines Glaxo's popular migraine drug Imitrex -- known generically as sumatriptan -- with the older painkiller naproxen sodium.

The drug combo attacks different pathways in the brain believed to contribute to migraines, which affect more than 28 million people in the United States. Migraine symptoms include throbbing headache pain, nausea, vomiting and sensitivity to light and sound.
The multibillion-dollar market for prescription migraine drugs is dominated by a class know as triptans, of which Glaxo's Imitrex is the most widely used.

Source: CNN

Something like this can get fast tracked by the FDA and in patient use in a very short time. If you suffer from migraines, this is good news.

I'm getting sick of seeing Dr. Jarvick

I've posted lipitor but here's a reference to that post.

see thursday march 1st...

Flomax coming shortly.......

Is chemotherapy right for you? Ask about Neulasta

This ad just amazes me. "ask your doctor if chemotherapy is right for you" is basically what this says. Just how many people even know anything about their disease except what they are told and even those dont know what drugs they are getting or how they work. Rant over.

Back to Neulasta. What is it indicated for and how does it work so we can all understand?

Neulasta is a genetically engineered human protein [it's grown in the laboratory] that is the exact same as a protein in our body call G-CSF, for granulocyte colony stimulating factor. Simply, it's a cocktail of growth factors that tells specific cells of your immune system to grow. These cells are the body's primary defense system against opportunistic infections that often occur in chemotherapy patients. This is important since most chemotherapy is not specific to cancer cells in the body. It simply kills all cells, leaving a person suspect to infection; thus how the drug protects and helps a person.