When it comes to prescription medication, doctors and patients often have to weight the healing benefits of the drugs prescribed with the possible side effects that may come with taking the drug. Some drugs may have ingredients that are extremely addictive and can put the patient at risk of addiction to the medication, while others may have side effects that may make the patient feel uncomfortable during treatment.

Unfortunately, some prescription drugs may come with serious side effects that can cause serious or long-term damage to the patient. In some cases, serious side effects were not discovered during clinical trials or came about long after the drug was released for consumer use. In such cases, the Food and Drug Administration (FDA) may institute a recall of the drug to remove it from pharmacy shelves and alert persons with prescriptions for the medication to discontinue use and return the product.

When it comes to prescription drug recalls, there are three basic levels of prescription recall. They are graded in levels and are usually grouped by the seriousness of the threat to the individual taking the drug. Level three recalls are usually the least serious of the group and are typically instituted to correct labeling mistakes and other minor issues that may have little or no effect on the patient. Level three recalls include defective bottles, coloring issues, and strange taste to the medication in question. The patient is usually not expected to experience any negative side-effects and may not be in danger at all.

Level two recalls are used for medication that may have slight side effects and may cause short term health problems for persons who were prescribed the drug. Level two recalls usually are more serious than level three recalls because the patients may experience health problems as a result of taking the drug but are usually not in danger of long term sickness.

Level three recalls are usually extremely serious in nature and are instituted if the medication has been shown to cause severe health problems and long-term injury to the individuals who have been given the medicine for treatment.

In the event of a prescription drug recall, the FDA will require the manufacturer to handle the recall and report back about the progress of the action. This means that the drug will be removed from consumer use and the public will be warned of the possible dangers of taking such medicine for the treatment of illness and injury.

If you have been harmed by a dangerous prescription drug, you may have the right to expect compensation for your pain, suffering, and medical expenses. For more information on prescription drug recalls, visit the website of the Pennsylvania product liability lawyers of Lowenthal & Abrams.

Phosphatidylserine is a new wonder drug recommended by health-food manufacturers for its efficacy in everything from aiding in increased sexual stamina for men, to easing symptoms of children’s Attention Deficit Hyperactivity Disorder (ADHD). There is also some evidence that phosphatidylserine (or PS) may aid the brain’s ability to retain memory and strengthen the body’s tolerance for exercise. Initial studies suggest that PS lowers the level of the stress hormone cortisol during workouts. Another benefit is that PS is legal to consume as a nutritional supplement for professional athletes.

Medical studies on PS chemicals only began in 1990, so no long term studies have been completed. PS has opened many doors of exciting new research that may eventually help with managing a variety of medical conditions over time. Some scientists such as chemist Andrew Hamilton, BSC, MRSC, believe that PS may be a tonic to prevent certain types of dementia and help encourage individuals to build up their own immune system by making exercise less painful. Hamilton claims that there are no documented negative side effects of PS.

Studies have advanced quickly enough for the US government’s Food and Drug Administration (FDA) to grant qualified health claim status to the substance in 2003. This means that any manufacturer or seller of PS could advertise the beneficial effects of PS with early types of dementia in elderly patients. But manufacturers cannot claim PS can cure dementia or Alzheimer’s disease. It is unknown when and if the FDA may grant another ‘qualified health status’ for adding physical endurance.

What Is PS?

Every cell in a plant or animal body contains PS. The cell needs PS in the membranes to help hormones communicate with one another. The cell membrane is the semi-solid wall that separates one cell from another. Cells communicate with each other by releasing chemicals from their membranes, which then encounter chemicals such as PS, which either recognize and accept the chemical inside the membrane or refuse it entry.

PS is found in brain or inner organ tissue more often than anywhere else, possibly because these organs require more hormones than other parts of the body.

Andrew Hamilton also states that living body cells may be able to store excess PS in times of need, such as when the body is stressed during vigorous exercise. This excess PS is not used in the cell membrane but instead uses the cell as a medium to help in absorbing and synthesizing such essential nutrients as potassium, calcium and sodium. This helps the cell work faster while the PS in the membranes assist all the cells to communicate more efficiently.

Medical Controversy

The first clinical studies of PS were conducted with the brains of dead cows. But after outbreaks of bovine spongiform encephalopathy (more commonly known as ‘mad cow disease’) researchers switched from cow brains to PS harvested from soybeans. Researchers are still reluctant to use cow tissue because of the public’s fear of ‘mad cow disease’ and the rise in vegetarianism, where consumers are consciously trying to avoid the use of any product requiring animal deaths. There is also a concern that animal tissue could rot faster than vegetable tissue and thus introduce viruses or other dangerous bacteria into a medication.

PS from cow brains and PS from soybeans are obviously not identical substances, however, a study confirmed that soybean and chicken egg-derived PS behaved in the same manner as cow brain-PS. (’Cognition-enhancing properties of subchronic phosphatidylserine (PS) treatment in middle-aged rats: comparison of bovine cortex PS with egg PS and soybean PS.’ A. Blokland, et al.; ‘Nature’; Oct. 1999.) Not all medical institutions are convinced that both substances are sufficiently the same. For example, the Mayo Clinic’s official position on phosphatidylserine is that ‘more research is needed’.

Conventional medicine does not often endorse nutritional or multivitamin supplements because the manufacturing standards are considered lower than what would normally be required for conventional pharmaceuticals. The health supplements industry is also a self-regulating industry. Alternative medicine practitioners point out that, even with government regulation, many dangerous drugs from pharmaceutical companies have been released to the general public over the years. Still, reputable complementary and alternative medicine practitioners urge patients to talk to their doctors before trying a supplement like PS. Individuals taking blood thinning medication or medicinal doses of vitamin E should avoid PS supplements altogether.

Sport Controversy

Even if PS does not stop pain and even if it does not improve athletic performance, could PS still be considered a performance-enhancing drug if it is proven to help amateur and professional athletes achieve enhanced endurance? This depends upon the individual sport, but generally the answer would be yes, unless the argument is made that since caffeine is an allowable substance, why not PS? Caffeine does momentarily make athletes more alert, but the effect shortly wears off. The weekend warrior could not take a pill and suddenly sprint past a race horse.

Golf may be one sport that would ban PS, if results of this 2008 study are be reproduced. Golfers in good health that took PS for six weeks were able to tee off more accurately, and further. (’The effect of phosphatidylserine on golf performance.’ Jager, R. et al.; ‘Journal of the International Science of Sports Nutrition.’ Dec. 2007). Another sport that might consider a ban would be road cycling, because they are even considering banning caffeine after numerous dope-scandals damaged the prestige of the Tour de France. This is one reason why chemists and sports enthusiasts like Andrew Hamilton are urging athletes to try PS now before public paranoia sets in.

Conclusion

There are some fascinating short-term studies that support the theory that phosphatidylserine (PS) can help with sports training. PS is legal, is now made from non-animal sources like soy and cabbage, but can be pricey. It has no known negative side effects except for making the blood thin slightly, which should not have an effect upon healthy individuals.

The Swine flu vaccine has drawn much controversy over whether it`s safe or not. Some people remember the 1976 Swine flu vaccine that did more harm than good, however the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are claiming that it is safe. With so many different opinions it`s hard to know what the right thing to do is.

Back in the summer of 2009, the swine flu hit everywhere hard. People who were normally healthy were getting sick and even dying from it. The flu hit people at record numbers and did so out of regular flu season. In light of that, a vaccine was in the works and was released in November.

The vaccine was at first released to only high needs groups. These groups included; pregnant women, babies and young children, and people with chronic health conditions and health care workers. There were line ups everywhere, as people waited in the cold to get a swine flu shot. Many people were eager and jumped on the idea to get vaccinated. However there were some, who were unsure as to its safety.

Some people felt strongly that it was too soon for a vaccine to come out and know what the effects are going to be. And these concerns came from people and some health officials. Some paediatricians refused to give out the shots. And this fear didn`t come out of nowhere. There was talk of the swine flu vaccine that hurt lots of people back in the seventies.

The drug administration claimed that the vaccine was safe and stated that the vaccine was manufactured using the same approved ingredients used to produce the seasonal influenza vaccine and that it didn`t contain any new adjuvant which are vaccine additives.

Still people had their doubts. They remembered that over five hundred cases of Guillain Barrre Syndrome were reported and that the vaccine was stopped. They found that the vaccine was actually doing more harm than good.

Officials responded claiming that the vaccine today is different from the vaccine three decades ago. Still, people felt that with a new vaccine it was hard to know what all the side effects would be.

The vaccine comes in three choices. It can be done in two doses for healthy people with an inactivated virus, or it can be in a single shot without the inactivated virus or it can be given through a nasal spray to healthy people two years old and up, and it contains a live attenuated flu virus.

Known side effects to the vaccine are having a mild fever, muscle aches, nausea, headache, fainting, soreness of the arm and a runny nose. The incidence of GBS is reported just as common as in the regular flu shot.

Many people still feel torn as to what to do over the vaccine. Even with all of the information out there, where some are claiming its bad and others say that its fine is still making people feel undecided. Nobody wants to give a vaccine to a child and then find out that it has adverse side effects that later come out. Nor do they want it to happen to themselves. On the other hand some people are just getting the shot and getting on with their lives. So are people just being worry warts over the whole vaccine issue? Only time will tell.

The world of medicines and drugs can indeed be quite interesting and exciting with new life saving and other drugs being invented by science. While this can be life saving and disease annihilating, there is also the possibility of many side effects resulting on account of the consumption of these drugs. There have been many instances of loss of life as well as severe complications due to patients being administered drugs that have reacted with their systems and caused many after effects. It is with a view to analyzing these effects that drug safety pharmacovigilance has been brought into effect as a field of medico-scientific enquiry.

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As the term implies, pharmacovigilance means being careful, alert and mindful of drugs. The specific emphasis in drug safety pharmacovigilance is studying the short term, medium term and long term after effects of various drugs. Drug safety is of great concern to doctors, patients and their families as well as the whole medical community and even the government. Nothing can be as devastating as a drug disaster and in the US, the Food and Drug Administration (FDA) takes great pains to ensure that improper drugs are not released into the market.

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Clinical trials of drugs are generally limited and restricted in their scope as testing involves only a few thousand human beings. That’s the reason why even very severe adverse drug reactions like liver damage are often not noticed because the study populations are small. Post marketing pharmacovigilance makes use of tools like gathering data and investigation of case reports to recognize the association between drugs and their adverse drug reactions.

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When the drug is released into the market, it would be administered to hundreds of thousands or even millions of patients. It is here that it should stand the test of being after effects free. Drug safety pharmacovigilance precisely tests this.