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Permax Recall

Staff Writer — Sat, 31 Mar 2007 14:37:36 GMT

The FDA has requested the Parkinson's disease drug Permax to be pulled from the market after studies showed Permax has been linked to heart valve damage and increased risk of heart attack.

At least 14 patients have needed to have heart valves replaced, but an FDA official says be believes that number to be higher.
Patients are being told not to stop using the drug abruptly, and to consult with their doctor about either a switch to another drug or about a gradual reduction in the amount of pergolide.

The agency's official estimates that over 12,000 people use Permax to treat symptoms of Parkinson's

Originally posted at InjuryBoard by Staff Writer

BPA, Who, What, When, Where, Why, and How!

Amber Wheat — Thu, 30 Oct 2008 16:34:28 GMT

Is it safe? Is it dangerous? If it isn’t safe, how come it has been used for so long? There is so much controversy centered around Bisphenol A. As most everybody now knows, BPA is a chemical that hardens plastics and is used in all sorts of consumer products. It is used by canners, plastic producers, and many other everyday manufacturers.

Where did BPA come from? In 1891, it was first reported. Today it is used because it makes thinner plastics shatterproof (among other things). Five companies in the U.S. manufacture it, including General Electric and Bayer Material Sciences.

The safety of BPA has been questioned since the 1930s but the current controversy started when in 1997 scientists discovered that BPA was damaging the reproductive organs of rats. The scientific community has been running tests since and has been issuing warnings. In April 2008 the U.S. Noational Toxicology Program issued a report that verified there was cause for concern. So...the public got concerned and the FDA stepped in to quell their fears. The FDA has said numerous times that BPA is safe. And why wouldn’t we believe them? It is their job to protect us, right?

Of course, as I found during my research on the FDA, they do not do their own testing and must rely on the creators of chemicals to submit reports. But, I’m sure that the manufacturers would let us know if it was unsafe (yeah right).

So, is it safe? Some say yes, some say no. Consumers can get a good summary of the situation thanks to an easy-to-understand article by The Associated Press that came out yesterday. One thing is for certain, the FDA needs an overhaul. Obviously this system is not working, what with the melamine being found in more and more products and the fact that their own subcommittee stated their conclusion was flawed. The FDA is asking companies to self-police. I ask you, what true capitalist company is going to admit that their product is harmful if they can get it past the FDA? And there wouldn’t be any consequences if preemption is allowed. All they have to do is tweak the data and get if passed by the FDA and then they are free from liability. What a horror. Something must be done, but what?

At least the FDA is being investigated regarding it’s relationship with manufacturers and users of BPA. There may be an issue of objectivity. Many people are upset that only industry-funded lab tests were used to determine safety, but they obviously haven’t read my blog and learned that the FDA does NOT DO THEIR OWN TESTING. They don’t have the money or the manpower. It is a broken system!

Steve Brozak and Larry Jindra, M.D., wrote an opinion on ABC News about the FDA and the need for reorganization. I don’t know much about bureaucracy, but I do know that too many cooks in the kitchen ruins the whole meal. Splitting the agency is a good idea, but what would really have an impact (in my naive, idealist opinion) is accountability.

People are looking at the FDA and saying “shame on you,” but what about the manufacturers, companies, and businesses who are actually responsible for putting it on the market? Why aren’t we blaming the people who skew the data? Why aren’t we blaming the liars and the cheats? Short cuts are taken in regard to safety so that producers can lower prices. We consumers demand low prices because most people are not willing to pay for quality. Well, we get what we pay for don’t we? Sorry, went off on a tangent. Consumerism isn’t the issue here.

The issue: Is it safe? Who knows? They say that it damages reproductive systems, well, I’m sorry, but generations have been exposed to BPA. Are people still getting pregnant? Yes. Is the population still going up? Yes. Are more and more people having to have medical help getting pregnant? Well... actually, yes. Invitro-fertilization is more and more popular and many couples take fertility medication in order to get pregnant. Is this just because the technology is more available to us, or are these measures truly necessary because we’ve been damaged?

The answer: we may never know! But we’re going to try to find out. Tomorrow the FDA’s Science Board will meet to discuss the controversy. I wonder what they will say, but keep in mind that it may take 2-5 years to complete additional research.

What do you think about all this? I am very interested to know what is going through your mind right now.

Originally posted at InjuryBoard by Amber Wheat

Bodee LLC, Inc. is Recalling Zencore Tabs Due to Undeclared Ingredients

Jenny Albano — Sat, 08 Sep 2007 09:11:14 GMT

Bodee LLC, Inc., in conjunction with the FDA, announced they are recalling the dietary supplement Zencore Tabs because of undeclared ingredients.

Representatives of the FDA found these undeclared ingredients during lab analysis and stated that the ingredients are potentially harmful to consumers.

FDA asserts that its chemical analysis revealed that one lot of Zencore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. Further, FDA declares another lot of Zencore Tabs contains sildenafil, the active ingredient of another FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Some consumers with conditions such as diabetes, who have high blood pressure, high cholesterol, or heart disease many need to take nitrates. Erectile Dysfunction is a common problem for men with these ailments, and some consumers may seek these kinds of products to better their sexual performance.

Zencore Tabs were sold in health food stores and through mail order across the U.S. and Canada. The product comes in a 2-capsule blister pack which is packaged in a booklet with five booklets in one box.

Bodee and the FDA are recommending that any consumer who is using Zencore Tabs should cease use immediately and should seek medical care if they are experiencing any problems. The company is working with the FDA to make sure their product will be safe in the future.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jenny Albano

The FDA, part 4 (The last part, I swear)

Amber Wheat — Sat, 27 Sep 2008 12:00:00 GMT

Despite all my research, the FDA is still one big mystery to me. I think I would understand more about what they protect us from if the public had access to information about drugs and products that have been rejected by the FDA. But giving out that information could violate intellectual property rights, damage reputations, and tip off competitors.

With the technology we have now it is easier than ever to learn about new and upcoming ideas in food and health. According to the FDA website, another duty of the FDA is to speed innovations that will make food more nutritious, make drugs more effective, and make everything more safe.

It must be a hard balance to maintain. On one hand the FDA must protect people from potentially harmful products, but they must also allow for experimentation, invention, and risk if we are to see progress.

But what do they actually DO?

The FDA regulates biologicals, cosmetics, drugs, foods (not meat and poultry), bottled water, medical devices, radiation-emitting electronic products, and veterinary products. For the most part food must be labeled correctly and safe (same with cosmetics). Drugs must be approved before being marketed (meaning they are effective and the risks do not far outweigh the benefits), labeled correctly, and manufactured in an approved plant.

Radiation-emitting electronic products must perform within FDA devised standards. Biological products must also take FDA standard into account, licensing is required (a very good thing since it involves the safety of the nation’s blood supply).

What does the FDA NOT do?

They do not regulate advertising, alcohol, consumer products (my good friends at the Consumer Product Safety Commission do that), illegal drugs with no approved medical use, health insurance, meat and poultry, pesticides, restaurants/grocery stores, or water (except bottled water, the FDA makes sure it’s labeled correctly).

So what happens if someone doesn’t follow the FDA’s rules?

If the product is really dangerous, a recall will be issued. There are fines that companies must pay. Inspectors can be disqualified and if the company is really bad they will debar them. Debarment bans a company from being in the drug business because of multiple violations.

I don’t know about you, but it seems to me like they get off pretty light. I know that the FDA is supposed to not curtail invention and new innovations, but companies who don’t play by the rules need to be held responsible for damages incurred by the public.

At least, that’s how I feel. I am glad I got to know more about the FDA, but I am a little disheartened by what I have learned. I am also hopeful that the recent spotlight on the FDA will bring some improvement to the program.

You know, communication is really key. People like to be in the loop and I think that is where our relationship with the FDA is lacking. The FDA needs to have a more public persona telling the citizens that they are out there in the world and that they take our safety seriously. And we need to talk back to them. We should tell the FDA what we are most concerned about and what we need.

No matter how hard the FDA works, we will not be safe if we don’t take responsibility for ourselves and the people who rely on us.

Originally posted at InjuryBoard by Amber Wheat

The FDA, part 3

Amber Wheat — Fri, 26 Sep 2008 16:36:48 GMT

Maybe some people were surprised at last Thursday’s report from the Government Accountability Office which states the FDA is letting contaminated produce fall through the cracks and onto our plates, but I was not.

After everything I’ve learned about how the FDA was created, how it operates, and it’s responsibilities, I can easily believe that only 1% of imported produce is investigated. Let’s remember that the FDA does not do their own testing. According to the FDA website, local county health departments are responsible for inspecting grocery stores and restaurants.

Of course the FDA relies on the industry to correct it’s own problems! What else can they do when they are not given the staff, the money, or the authority to take it a step further?

On to the Last Part

Originally posted at InjuryBoard by Amber Wheat

The FDA, part 2

Amber Wheat — Thu, 25 Sep 2008 16:11:33 GMT

The Food and Drug Administration is responsible for a wide range of products, but the one people think of most often is prescription drugs. As I said in my earlier post, the FDA was originally created to protect the public from products that claimed to do something it didn’t (like cure cancer, or whatnot). The FDA demanded truthful labeling and wouldn’t allow companies to say their product had a certain effect if the company couldn’t prove in clinical trials that the product really did do that.

Something that has always bothered me about medications on the market today are the side effects. At the end of the very nice commercial with people walking on the beach and getting the most out of their lives, a very quick, professional voice speaks over the picture. This disembodied voice warns of complications like “death and cancer may occur”. Death may occur? Really? Why is this medication even allowed if death may occur? Isn’t the FDA supposed to protect us from death occurring?

The answer is... kind of. The FDA knows that the product has nasty side effects, but because the maker warns us of them, it becomes our own choice to take that risk. If people living with fibromyalgia or any other condition that causes them to have to live with daily pain choose to take these medications to alleviate some of their suffering, the FDA lets them make that choice.

When decided whether or not to let a new drug into the market, the FDA looks at the benefits of the drug balanced against the risks. Remember, the FDA doesn’t do their own testing. They make their decisions based on the manufacturer’s clinical studies. It is hard to say what is worth the risk of death. I don’t live with rheumatoid arthritis or fibromyalgia or any other condition that causes people a great deal of pain, so I don’t have to make a choice like that.

It just seems like the FDA doesn’t do much to protect the public. Of course, if it was the government’s responsibility to protect people from themselves we wouldn’t have nearly as much freedom as we do now. But rules like the prohibition of releasing information on drugs that are under review by the FDA seems counterproductive. Yes, you want to preserve the privacy (and profits) of the company making the drug, but in the meantime, the public is still buying and taking the drug that, for some reason, the FDA felt the need to review. What is wrong with it? Why is it being reviewed? Should I stop taking it? Don’t we have a right to know these things?

What do you think?

Read Part 3

Originally posted at InjuryBoard by Amber Wheat

The FDA, part 1

Amber Wheat — Wed, 24 Sep 2008 17:41:58 GMT

With all the news about China’s milk and recent litigation involving skin creams and eye washes that are having nasty side effects (and, of course, the BPA plastic scare) I began to wonder what responsibility the FDA has.

I did not know this, but the FDA’s primarily responsibility when it was created was to regulate labeling. The department was created because packaging was making claims that the product couldn’t fulfill. The public saw this mostly in snake oil type medicinal products. The FDA wanted to put a stop to the misleading labels.

Eventually the FDA started looking at safety and whether or not a product was good for the public. Items that were merely unhealthy (like candy) was not at issue, but new and innovative products like sugar substitutes became a problem when they had dangerous side effects. In 1958 the department created the first Substances Generally Recognized as Safe list. And the department turned it’s attention to preventing the sell of dangerous products instead of just labeling them.

When deciding what is safe and what is not safe in our food, the FDA looks at sanitation more than anything else. Bacteria were the main concern. However, with new technologies and new ways to process food, the FDA had to turn their attention to how products interacted with our bodies. In 1971, Saccharin was taken off the GRAS list and researched in depth. They found that it was having nasty side-effects and wanted it taken off the market, but in 1977 Congress stopped the FDA from banning Saccharin and said that the manufacturers were only required to properly label their products. In 1996, the requirement to label was no longer in effect. Congress has basically relegated the FDA back to just labeling what’s bad for us. Only two substances have been allowed to be banned under the FDA’s discretion, L-Tryptophan and ephedrine alkaloids.

It sometimes makes me wonder what the FDA actually does to protect the public. What can they really do it they have no power to enforce the research they conduct.

A frightening thing I learned was that the FDA does not do it’s own testing. The creators of new substances are required to test their products for safety and efficacy. Those reports are submitted to the FDA and that is how they make their decisions. This process means the FDA won’t know there’s a problem with a product until it is out on the market and people are getting sick.

I understand that we cannot expect a single government agency to test everything we eat, drink, or otherwise put into our bodies, but it seems like a conflict of interest to just take the manufacturer’s word for it that their product is safe. Of course, because of this process, the FDA will never be liable for damages caused by tainted food, bad drugs, or unsafe products because is not their responsibility to protect us from anything that can hurt us. After all, cigarettes, alcohol, candy, and many other products that are bad for our health are not only still legal, but they make the government a lot of money in taxes.

The only thing they are really responsible for is labeling, check it out, you’ve been warned.

On to Part 2

Originally posted at InjuryBoard by Amber Wheat

BPA in Plastic- Questions, Answers, and more Questions

Amber Wheat — Tue, 16 Sep 2008 14:56:41 GMT

There is a lot of research going on right now on the chemical BPA which is used in baby bottles and other plastics to make them shatter-proof. Some studies have shown that the chemical can cause damage to reproductive systems; others have shown that it creates a higher risk of getting diabetes. The FDA is busy defending their position that the chemical is safe while the politicians in Sacramento try to get all plastic products with the chemical banned from the state.

Suffice it to say, there is so much information out there, the public can’t be anything but confused. I read a good article today with easy questions and answers.

Whether or not we like it, the FDA is not the most thorough testing agency in the world and a lot of stuff gets past them that really shouldn’t. There are products out there that are dangerous to our health, so please be careful.

Don’t forget about the Chinese baby formula either. American formula is fine, but some authentic Asian food stores may carry the brand that was found to be tainted.

If you have been harmed by food or drugs that were later recalled or found to be unsafe, please give us a call. It is not okay that these products get past all the security measures in place. Somebody is responsible and we’ll find out who.

Originally posted at InjuryBoard by Amber Wheat

TWC Global LLC, Inc. Issues a Recall of Axcil and Desirin

Jenny Albano — Sat, 22 Sep 2007 19:23:20 GMT

TWC Global LLC, Inc., in conjunction with the FDA, is recalling Axcil and Desirin products marked as dietary supplements because they include potentially dangerous unlabeled ingredients.

FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers who have diabetes, high blood pressure, heart disease of have high cholesterol may take nitrates for their condition. These consumers often have problems with sexual dysfunction and may take these type of products to improve sexual performance.

Axcil and Desirin are sold throughout the U.S. on the Internet. The pills are sold as a 15-capsule blister pack packaged in a box.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Jenny Albano

Trasylol Increases a Patients Risk of Death

Laura Mackie — Mon, 19 Feb 2007 12:31:35 GMT

According to a study recently published ( February 7, 2007) in the Journal of the American Medical Association, there is a significant increase in the possibility of death for patients taking the anti-bleeding drug known as aprotinin following cardiac surgery. Although aprotinin was approved by The Food and Drug Administration (FDA) in 1993, more recent advice by the agency has been to closely monitor patients using the drug. Their concerns focus on the safety of administering anti-bleeding drugs to post cardiac surgery patients. Bayer Pharmaceuticals, who markets apropinin as Trasylol, revealed just last year, that they have information which shows an increase in the risk of death, organ damage and heart failure from using the drug.

The best information to date indicates a 48% increase in the risk of death when compared to patients taking the drugs aminocaproic acid and tranexamic acid. The group of doctors who conducted the two most recent studies on the matter, suggested that prescription of aprotinin among patients undergoing CABG surgery is not prudent, since safer and cheaper alternatives (aminocaproic acid and tranexamic acid) are available.

If you or a loved one has suffered injury as a result of taking this medication, please contact a legal professional for assistance in determining what rights for recovery you may have under the law.

Originally posted at InjuryBoard by Laura Mackie