Reuters symptoms and conditions

WASHINGTON, Sept 17 (Reuters) - The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday.

The head of the U.S. House of Representatives Oversight and Government Reform Committee questioned how the FDA set its priorities given recent controversies over its handling of safety issues, including tracking tainted foods and inspecting drug manufacturers.

A 2007 list of top projects includes plans to offer advice to companies on promoting products, as well as guidance on offering reprints of journal articles to physicians, California Democrat Henry Waxman said in a letter to FDA Commissioner Andrew von Eschenbach.

The agency also planned to change its regulations to protect device makers from lawsuits as long as their products are FDA-approved with a so-called preemption clause.

"All appear to prioritize industry desires over consumer protection," Waxman wrote.

The FDA has come under fire in recent years following a string of highly-publicized safety scares, starting with the 2004 withdrawal of Merck & Co Inc's (MRK.N: Quote, Profile, Research, Stock Buzz) painkiller Vioxx following heart problems.

The risk of suicide with antidepressants and other drugs, as well as tainted batches of blood-thinner heparin and bacteria-laced produce such as spinach and hot peppers have also fueled concerns.

Asked if it had any response, FDA spokeswoman Heidi Rebello said the agency would comment directly to Waxman
THE DAYS OF RECKONING ARE COMING

Took 1 dose. Within hours, I awoke with a very dry mouth and severe heartburn. Went to the kitchen for water and nearly passed out. Nausea, so I made it to the bathroom. Cold sweats, then chills. Felt like I had the flu. Every time I stood up, I nearly passed out and kept having same symptoms most of the night. Next day, at work, I had to be taken to the nurse, who figured out that my already low blood pressure was dropping dramatically when I stood up (as well as my pulse rate increasing). I threw up all over the doctor's bathroom. Still feel awful 3 days later. Dr. pretty much indicated that blood pressure drop couldn't have been from the Crestor, although my father has had same thing happen with EVERY statin they've put him on. Now, my leg aches and my urine is dark

I have been on here for 6 months now. Please read the rest of my postings. My son is now 5 and doing great! I have my child back. He has been off Singulair since October 07. It took a few days to see little improvement. It took a month to make strides. And now we are almost home. Thank God. I too until I found this website was so distraught. My son had every test in world, comes from about as stable as you can get happy loving catholic home. We eat healthy organic foods and I am a medical professional to top it off. So for anyone to get on here and questions a parents "parenting" or to call them ignorant for not stating their complaints until now is simply a moron! I see the side effects first hand this has had on children. I too was unaware of the problem myself until my son became the victim at only the innocent age of 4. Merck knows what is going on. There needs to be a class action lawsuit. I am so proud of Kate whose son became the victim of Merck who took his innocent life. She went beyond blogging and took it to media. Imagine if all of us became motivated enough to realize the drug company used and abused our children or selves. Write oprah, bill o riley, merck the fda, everyone. Everyone I come in contact with I warn them. I email everyone I know and urge them to forward it and so on. The one god given duty that we were given was to protect our children. WE NEED TO DO THAT!! I am so proud of the parents who are speaking out and realizing their kid is not a pyscho. Kudos to you!! I am holding Merck responsible for this traumatic event it caused my entire family let alone my four year old son. They owe us big time, not just for the medical bills that endowed for all the tests, doctor visit, and psychiatric visits. But also for our mental anguish!! Be active and we will make progress!!!

WASHINGTON (Reuters) - U.S. health regulators are probing a possible connection between Merck & Co Inc's blockbuster Singulair asthma drug and suicidal behavior in adults and children, the Food and Drug Administration said on Thursday.

The persons who have no symptomatic effects are so fortunate with Singulair. A medicine out in circulation abusing one's emotions, lifestyle, threatening life is a circumference, detrimental side effect.

statins trigger neuromuscular disorders--there are many many neuromuscular disorders thought to be due to mitochondrial dysfunction (which underlies all the disorders mentioned here--including ALS, Parkinson's, Alzheimer's, as well as all the mitochondrial cytopathy disorders:

NEW YORK (Reuters Health) Jul 26 - Patients with asymptomatic neuromuscular disorders may have their condition precipitated by statin use, according to investigators from the University of Athens Medical School.

Dr. Panagiota Manta and colleagues describe four such cases in the July 24th issue of the Archives of Internal Medicine.

Case 1 was a 46-year-old man with a history of hypertension and diabetes mellitus who was prescribed pravastatin for hypercholesterolemia. Three months later, he complained of fatigue, muscle pain and stiffness. Serum creatine kinase levels were persistently elevated. After stopping the drug, creatine kinase levels fell somewhat and there was mild symptom improvement. Mild myopathy was seen on needle electromyography and muscle biopsy showed numerous internal nuclei, nuclear clumps and variations in fiber size. Genetic testing revealed myotonic dystrophy.

Case 2 was a 62-year-old man with a history of MI and diabetes. Hypercholesterolemia was treated with simvastatin. Creatine kinase levels became persistently elevated and did not return to normal after drug discontinuation. Biopsy was positive for muscle enzyme activity. He was eventually diagnosed with McArdle disease.

Case 3 was a 51-year-old man with hypertension and hypercholesterolemia who was hospitalized with acute rhabdomyolytis after taking atorvastatin for 18 months. Exercise intolerance and muscle pain persisted for months after discontinuation of statin therapy. Some time later, he was diagnosed with mitochondrial myopathy.

The last case was a 58-year-old man with a history of hypertension, hyperuricemia and coronary artery disease. He began treatment with pravastatin. Shortly after a dose increase, he developed muscle twitching, muscle cramps and difficulty walking. Like the other cases, there was only mild symptom improvement and a modest decline in creatine kinase levels after the statin was discontinued. He was eventually diagnosed with Kennedy disease.

Statin-induced neuropathy is well recognized and reported more and more often, Dr. Manta's group notes. These four cases show that statins can also trigger underlying neuromuscular conditions.

The investigators suggest that if neuromuscular symptoms persist after discontinuation of statin therapy, clinicians should "pursue further diagnostic evaluations for the detection of underlying neuromuscular disease."

Arch Intern Med 2006;166:1519-1524.

the following concerns another statin drug, crestor. since almost all statins work by blocking the pathway to make cholesterol....
By Lisa Richwine

WASHINGTON (Reuters) - Twenty-nine patients who took AstraZeneca Plc's cholesterol drug Crestor have developed kidney damage, a U.S. consumer group said on Friday as it called again for a ban on the medicine.

The rate of reported kidney problems is about 75 times higher with Crestor than with all other drugs in the same cl-------- combined, consumer group Public Citizen said. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled.

"It becomes clearer by the day that this drug is uniquely toxic without offering any unique benefit, and that it must be removed from the market," Dr. Sidney Wolfe, head of Public Citizen's Health Research Group, wrote in a letter to the Food and Drug Administration (news - web sites).

AstraZeneca insists Crestor, known generically as rosuvastatin, is as safe as other drugs in the family known as statins. The FDA (news - web sites) has agreed but promised to closely monitor reports of safety problems.

"Our data shows, with regard to that particular adverse event, it remains in line with other statins," company spokeswoman Emily Denney said. She added that AstraZeneca updates Crestor's reported health problems every week on its Web site www.rosuvastatininformation.com.

According to the site, "serious" kidney problems are "very rare" and occur at a rate of less than 1 in 10,000. Of all statin-related kidney problems reported to the FDA, 3.5 percent were related to Crestor as of early October, the site said.

Writing in this week's edition of The Lancet medical journal, AstraZeneca said Crestor's "safety profile is similar to those of the marketed statins. This view of the benefit-risk profile ... is shared by regulatory authorities in the 64 countries where rosuvastatin is approved."

The company's letter was written in response to earlier criticism from Wolfe.

Public Citizen said its latest analysis was based on reports to the FDA since Crestor's approval in September 2003 through Aug. 26, 2004. The reports of "adverse events" from doctors, patients, manufacturers and others do not prove if a drug caused a particular problem, but the FDA uses them to look for signals of possible drug-induced hazards.

Millions of people worldwide take statins, such as Pfizer Inc.'s Lipitor (news - web sites) and Merck & Co Inc.'s Zocor, to lower their cholesterol. High cholesterol is a major risk factor for heart disease.

Bayer AG's statin Baycol was pulled from the market in 2001 after it was linked to more than 100 deaths, many of them from a severe muscle-damaging condition called rhabdomyolysis.

The FDA has received 65 reports of rhabdomyolysis in Crestor patients, which is similar to the rate --------ociated with Baycol, Public Citizen said. AstraZeneca says the problem, also linked to other statins, is rare with Crestor.