Pregnancy is a nine month journey for both you and your baby. During this time your own body will change, both internally and externally. Although a woman’s body was beautifully designed to give birth, this process may cause a woman some discomfort and impose some limitations. Usually, exercise and good nutrition can alleviate the minor discomfort of pregnancy.

Some women also may begin to feel a little nauseous, and her breasts may become more tender or may tingle somewhat.

By the end of the second month, the levels of progesterone and estrogen are increasing dramatically, which will generally lead to some pretty serious mood swings that start now and continue through her pregnancy.

During pregnancy, your hormones are changing. This may cause you to experience ups and downs. You may feel excited, tired, worried, or like you need to talk about everything that is happening to you.

A vaginal discharge occurs normally during pregnancy, because of hormonal changes. A yellow or cheesy white discharge that is accompanied by itching or burning is not normal and needs to be reported to you health care provider.

Folic acid supplements are recommended for women trying to conceive and during the first trimester of pregnancy. This is the time that the baby’s brain and nervous system are developing. Folic acid has been shown to reduce the chance of a baby being born with problems known as neural tube defects, such as spinal bifida.

Cardiac output increases approximately 40% during pregnancy, reaching its maximum at 20-24 week’s gestation and continuing at this level until term. The increase in output can be as much as1, 5L/min over the non pregnant level. Cardiac output is very sensitive to changes in body position. This sensitivity increases with lengthening gestation, presumably because the uterus impinges upon the inferior vena cava, thereby decreasing blood return to the heart.

Many pregnant women complain of dizziness and lightheadedness throughout their pregnancies. Fainting is rare but does happen even in some healthy pregnant women. There are many reasons for these symptoms. The growth of more blood vessels in early pregnancy, the pressure of the expanding uterus on blood vessels and the body’s increased need for food all can make a pregnant woman feel lightheaded and dizzy.

During your pregnancy, you might feel tired even after you’ve had a lot of sleep. Many women find they’re particularly exhausted in the first trimester. Don’t worry, this is normal! This is your body’s way of telling you that you need more rest.

Heat stress during exercise creates concern for two reasons. First, an increase in the mother’s core temperature (hyperthermia) can be harmful to the baby’s development. Second, loss of water in the mother (dehydration) can decrease the amount of blood available to the fetus and lead to increased risk of preterm contractions.

Acne will be another big concern for you during your pregnancy. No matter how bad they become, stay away from medications as they might affect the baby. Not all women have this problem and you may luck out and find that your skin clears up during pregnancy.

About the Author

By: peterhutch

Article Source: http://www.articlesbase.com/ – How Body Changes Occur During Pregnancy

A drug that is structurally very similar to already known drugs, with only minor differences. The term “me-too” carries a negative connotation. However, me-too products may create competition and drive prices down1.

The majority of the new products the industry puts out, are â??me-tooâ? drugs, which are almost identical to current treatments but â??no better than drugs already on the market to treat the same condition.â? Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as theyâ??re more effective than a placebo, they can get the regulatory green light2.

This isnâ??t surprising at all, as someone who works in the field, but these so-called â??me-tooâ? drugs, which are reportedly better than their forebears, is driving costs. A â??me-tooâ? drug is a drug that has its origins in another drug. Probably the most famous example of this is Prilosec (â??The Purple Pillâ?) and Nexium (â??Todayâ??s Purple Pillâ?). Prilosecâ??s active ingredient is omeprazole. Nexiumâ??s active ingredient is called esomeprazole. The difference is that Nexium is the left-handed version of omeprazole. In chemistry, S stands for sinister, which means the molecular conformation has a left-handed orientation. (D would be right handed.) So this S-omeprazole is one half of the mixture that comprises its predecessor. By specifically picking only the S conformation, the drug is made more potent. This sounds great, but its efficacy is only marginally better than Prilosec-, which has a generic version, and costs about a third less than Nexium. Some other â??me-tooâ? drugs are: Claritin (loratidine) and Clarinex (desloratidine), Celexa (citalopram) and Lexapro (escitalopram)3.

What are “Me-Too” drugs?

Ever since the advent of modern chemotherapy, when drugs were discovered and developed through the process of screening thousands of molecules for a variety of disease conditions, using animal models, there has been a growing criticism that too many molecules were developed with similar chemical structure and the same pharmacological profile, with very little to distinguish them from each other in terms of their therapeutic utility. In other words, once the first breakthrough discovery is made of a new pharmacological activity for a new molecule, subsequent years saw the emergence of a host of new molecules or “me-too” drugs from the same chemical class and possessing the same pharmacological profile.

Such follow-up drugs have been termed molecular modifications, molecular roulettes or copycats, the development of which are alleged to be motivated by purely commercial considerations. They are also deemed to involve lower levels of innovation, compared to the original molecule. It is important to analyze in a historical perspective the end results of such efforts in different therapeutic areas of developing new molecular entities, as later generation products, after an initial breakthrough discovery has been made and the technical, medical and commercial merits of developing such drugs.

Development of “Me-Too” drugs

The success rate in the discovery of new chemical entities with fundamentally new chemical and biological profiles of activity are very low. In fact, even chemical entities within the same structural class of an approved drug are becoming rare now, compared to the period of sixties to eighties. In 2001, $ 26 billion was spent on developing new drugs and the U.S. FDA approved only 9 new chemical entities. At the same time, two thirds of the drugs approved from 1989 to 2000 were modified versions of existing drugs or even identical to those, in newer forms and formulations4.

Of the 1,035 drugs approved by FDA during 1989 to 2000, only 361 or 35% contained new active ingredients. Of these, only fewer than half were granted priority review status by the FDA. One impression is that these drugs are slightly altered versions of existing drugs, with little to offer in terms of better activity or tolerance, let alone new pharmacological profiles. The implication is that such drugs are developed, as patents on top-selling original drugs run out and not many truly new medicines are discovered. The indication that many of these drugs do not offer any major advantages over existing drugs is given by FDA’s unwillingness to grant priority review for most of them.

On the other hand, conventionally, the Regulatory Agencies, including the FDA, are not obliged to consider better efficacy over existing drugs as a criterion for approval; rather, they require only the establishment of efficacy and safety of the new drug over a placebo.

How good are they?

Notwithstanding such perceptions, historically, many “me-too” drugs have proved to be considerably better than their original counterparts. Examples are a series of generations of beta-blockers, which came up after the original drug Propanalol was discovered by ICI, with most of them having merits in terms of better efficacy, cardio-selectivity and safety. Ranitidine, the first follow-up drug after the introduction of the first H-2 receptor antagonist, Cimetidine, was followed by Famotidine and in each case these “me-too” drugs had notable merits over the original drug.

Apart from the major breakthrough in the development of orally active beta lactam antibiotics of the Penicillin and Cephalosporin class, within the same oral derivatives, there have been considerable improvements brought about by change in the side chains incorporated by condensation of specific agents with 6-APA, 7-ADCA and 7-ACA. A whole new range of broad-spectrum antibiotics of these structural classes could thus be developed. In each of the major classes of antibiotics, classified according to the mechanisms of their action, namely inhibition of cell wall synthesis (Beta Lactams, Vancomycin), inhibition of bacterial protein synthesis (Erythromycin, Tetracycline, Streptomycin), inhibitors of DNA or RNA replication (Quinolones, Rifamycins), inhibition of Folate Coenzyme biosynthesis (Sulfa drugs, Trimethoprim), there have been several “me-too” drugs marketed.

An important recent example to show that ‘me-too” drugs need to be developed is the case of the oral hypoglycemic drug Troglitazone, approved as an anti-diabetic drug in 1997. The drug was withdrawn from the market following reports of unacceptable hepato-toxicity. The follow-up “me-too” drugs, Rosiglitazone and Pioglitazone are much less toxic and are today widely used. If these drugs were not developed, the withdrawal of Troglitazone would have left a major therapeutic gap in anti-diabetic therapy.

“Me-Too” drugs: Strategies for New Drug Research for Indian Companies

Breakthrough innovations in pharmaceutical industry, of new drugs, such as the first beta blocker, the first NSAID, the first of each class of Antibiotics, Calcium Channel blockers, ACE inhibitors, Sulfonyl Ureas, Biguanides, Insulin, Glitazones, Glinides, Tricyclic Anti Depressants,major and minor Traquillisers, Selective Serotonin Receptor inhibitors, H-1 and H-2 Receptor antagonists, Proton Pump inhibitors etc are relatively rare and even though a few of the original drugs under these classes are still very much in use, they have been superceded in most cases, by later generation products, many of them “me-too”. The newer drugs are discovered both through incremental innovations on the original drugs as well as through new research.

Generally the original discovery leads to feverish activity both within the innovator company as well as in Competitors’ laboratories, to develop better products in the same therapeutic category. The essential caveat for commercial success, however, is that the newly discovered molecules should meet the minimum standards of patentability. For example within three years of the discovery of the highly successful Sildinafil Citrate (Viagra), three more new versions for the same indications have been patented and developed5.

Me-too drugs also provide therapeutic advantage6. For the practicing physicians, there’s the benefit of established drug MoA with a “me-too” medication, coupled with clinical studies that – hopefully – show patient-centered benefits such as better adverse events profiles, less frequent dosing, less bothersome potential for drug/drug interactions, and so forth. A “me-too” drug is a helluva lot easier to incorporate in practice than a totally novel medication7.

“Me-Too” drugs: The hidden dynamics

The most common criticism of drug development centers on the so-called “me-too” drugs that employ the same biological mechanism as pioneer brands. This involves a lot more than such high-profile targets as the anti-ulcer drug Nexium. We should be thinking about antidepressants, cholesterol-reducing drugs, diabetes treatments, anti-psychotics, and other therapeutic categories that have seen both blockbuster sales and rapid innovation. There is quite a bit of evidence that follow-on drugs do a lot of patients a lot of good. The newer statins, for example, often out-perform the older ones in clinical trials where the endpoints are the number of heart attacks and deaths prevented.

Me-too drugs are also a powerful tool for cutting health care costs. We should be glad that our research industry does not target only brand new biological mechanisms. That would be a very expensive business model indeed. Fortunately, the industry also works on marginal improvements, exploiting opportunities to make drug therapy better and sometimes opening the door to really radical improvements that happen to lie more or less next-door, scientifically speaking. In the meantime, we get price competition as a by-product. Me-too’s almost always undercut the prices of the pioneer drugs.

Another part of the me-too story gets almost completely ignored even though it is extraordinary important. For me-too manufacturers, advancing the science is a way to gain a competitive advantage. The classic example is the statin class of cholesterol drugs. Research on one of the follow-on drugs (Pravachol) demonstrated for the first time that using a statin to reduce cholesterol would actually prevent deaths from heart attacks, something that had previously been assumed without proof. Additional trials for several statins, including Lipitor, the formidable challenger to Zocor and Pravachol, have demonstrated that serum cholesterol is far more important than almost anyone thought (for preventing strokes, for example).

There are lots of other stories about the benefits of new research from me-too drugs, but they are part of a larger story: new uses for old drugs. The data showing a slowdown in new drug approvals exclude essential information: discoveries of new uses for old drugs. This kind of discovery has become so common that it amounts to a “new-use” revolution. One of the scientific ironies of the new era of pharmaceutical research is that as drugs become more tightly targeted on biological mechanisms, their uses actually become more diverse. This is because the body typically uses specific mechanisms over and over again, sometimes in what appear to be completely unrelated ways.

Consider the SSRI antidepressants. A recent Science article on the diverse and unexpected applications of drugs that fiddle with serotonin reuptake which is what the SSRIs do concluded that the very term “antidepressant” is misleading because there is no scientific reason to think of this drug as being just for depression. Fighting depression just happened to be the first really useful condition that was explored for this very interesting class of drugs.

Another example is the Cox-2 inhibitors like Celebrex (and Vioxx, which is important in this story and may return to the market partly for this reason). These were invented to relieve arthritis pain. But the Cox-2 enzyme turns out to be important for lots of things including cancer and Alzheimer’s. Clinical trials to exploit these leads have been underway for years. Celebrex has already been approved for reducing the risk of colorectal cancer, and Vioxx has also achieved promising results. Of course, the big news recently has been that these drugs may cause heart attacks. But even here, me-too economics is of surpassing importance. The traditional NSAIDS (non-steroidal anti-inflammatory drugs) like Alleve and Advil may have the same heart attack risks. The potential risk has been there for decades, but only the new drugs-the Cox-2s-have been put through large-scale long-term clinical trials because those are the only ones still under patent. This is an example of how me-too drug development adds importantly to the research base. Thanks to the me-too’s, we are learning about NSAIDs, heart attacks, cancer and probably much more.

Also dominated by new uses are the new-targeted cancer drugs, which attack such specific biological mechanisms that they avoid killing every fast-growing cell in sight (as traditional chemotherapy tends to do).

The implications are clear. The annual count of new drug approvals will only show a tick when a new cancer drug or a new statin gets its very first approval. But a new use for an old drug can be as valuable as an entirely new drug, or even more valuable when you consider that we know more about the safety profile of old drugs and one drug will sometimes do the work of two (preventing both heart attacks and strokes, for example)8.

Me-too products can sometimes have important advantages on tolerability or dosing. It could help create more competition and lower the price. If you have five me-toos, possibly the sixth is something that is a little better. That is for the plans to decide on behalf of their patients. And even if it has the same mechanism of action, more competition could help drive down the price of the entire class. Thatâ??s an important influence, with potentially an improvement in health from greater access.

How bad are they?

Even though the major problem of antibiotic therapy, namely drug resistance cannot be addressed by the development of “me-too” drugs, due to the propensity of the same class to develop cross resistance; in most cases, the new semi-synthetic derivatives had distinct advantages over the earlier ones. Thus, for example, the first generation Cephalosporins are useful for gram-positive infections, while the second-generation drugs cover a broader spectrum including gram-negative organisms. The third generation drugs provide resistance against the beta lactamase enzyme, as well as acting against some of the most intractable infections, such as those caused by Pseudomonas and Klebsiella strains.

Even while the pharmaceutical industry turns out families of me-too drugs for relatively mild conditions in affluent people, it pays almost no attention to serious diseases, such as malaria, affecting impoverished people. It also gives short shrift to less profitable drugs, so there now are shortages of some vaccines and life-saving drugs9.

The big problem with me-too drugs is that they are chemically very similar to other drugs already available, yet they are marketed as if they were important new breakthroughs, with very high prices. Many new, expensive me-too drugs are not necessarily better than older and less expensive drugs. Most of the time they are compared with placebos and not older drug comparisons.

“Me-too” drugs are responsible for 80% of increased spending in recent years, and on average they are four times more expensive than the comparable, older alternatives10. By Patented Medicines Pricing Review Board’s (PMPRB) definitions, at the time of their introduction â??me-tooâ? drugs were judged to provide moderate, little or no improvement – in terms of effectiveness and safety – compared to older alternatives. However, on average, â??me-tooâ? drugs cost about 2.5 times as much per prescription as comparable older drugs. The question is whether the perceived or real differences justify the increased costs. New drugs do have a role in some situations and for some patients. However, it makes sense to use the older equally effective drugs whenever possible11.

Changing FDA rules to discourage me-too drug approvals would make R&D far more expensive, would discourage competition and therefore raise healthcare costs, and would forestall the wave of new research that has revolutionized our scientific understanding of the therapeutic categories where competition has been most intense.

Conclusion

New drugs are not required to improve on old ones, and thereâ??s usually no way to know whether they do. Although the FDA must test drugs before they are marketed, they donâ??t need to be compared with similar drugs already on the market. The FDA only requires they be reasonably safe and better than nothing-a low standard indeed. This loophole in FDA regulations opens the door for an unlimited number of me-too drugs, which are easier to develop than innovative drugs.

Given everything, it should come as no surprise that these more expensive â??me-tooâ? drugs cost the medical industry money. The prevalence of the me-too’s really says an awful lot about the lack of innovation within the pharmaceutical industry. If you look at the new drugs marketed over the last six years, 78 percent weren’t even new chemical compounds. They were just new combinations or different formulations of old drugs. And 68 percent were classified by the F.D.A. as unlikely to be improvements over drugs already on pharmacy shelves.

At the same time, there are shortages of some important drugs that the pharmaceutical companies aren’t much interested in making because they are not as profitable as the me-too’s. But the companies don’t have to turn out needed drugs, if they are not lucrative. And they don’t.

References

1. http://www.medterms.com/script/main/art.asp?articlekey=33748

2. http://www.motherjones.com/news/qa/2004/09/09_401.html

3. http://polyscience.org/2005/09/me-too-drugs

4. http://www.shvoong.com/books/465475-me-too-drugs

5. http://www.pharmabiz.com/article/detnews.asp?SecArch=&articleid=14604&sectionid=46

6. http://direct.bl.uk/bld/PlaceOrder.do?UIN=162532605&ETOC=RN&from=searchengine

7. http://www.archivum.info/sci.med/2005-09/msg00257.html

8. http://www.aei.org/publications/filter.all,pubID.27443/pub_detail.asp

9. http://blogs.wsj.com/health/2007/05/17/in-praise-of-me-too-drugs

10. http://www.chepa.org/KnowledgeExchange/LabelleLectureship/tabid/84/Default.aspx

11. http://www.ti.ubc.ca/pages/letter59.html

Causes and Symptoms of Benzodiazepine

At normal or regular doses, benzodiazepines relieve anxiety and insomnia. Benzodiazepines over dose causes side effects like drowsy or dizzy. High doses of benzodiazepines can produce more serious side effects. Signs and symptoms of acute toxicity or overdose may include Drowsiness, Confusion, Dizziness, Blurred vision, Weakness, Slurred speech, Lack of coordination, Difficulty breathing and even Coma.

Signs of chronic drug abuse can be very nonspecific and include changes in appearance and behavior that affect relationships and work performance. Warning signs in children include abrupt changes in mood or deterioration of school performance. Chronic abuse of benzodiazepines can lead to symptoms like anxiety, insomnia, anorexia, headaches, and weakness.

Monitoring and Testing of Benzodiazepine

· Benzodiazepines drug abuse can be detected with Saliva drug test.

· Urine drug screens are used to find the addiction levels for Benzodiazepines. Lab tests can detect many of the commonly abused drugs, including benzodiazepines (but may not be able to discover them all). The urine drug screens do not, however, reveal a specific level or amount of the drug taken. However, it is difficult to find the level of addiction for Benzodiazepine as it varies from individual.

· In the case of overdose of Benzodiazepine, in the emergency department, patient will be placed on a monitor evaluating heart rate, blood pressure, and pulse oximetry. An IV line will be started. Oxygen is given if patient is short of breath or has a reduced level of consciousness.

Oral Fluids can detect:

• ALCOHOL - Q.E.D. Saliva Alcohol Test (rapid)

• NIDA-5 - THC, Cocaine, Opiates, Amphetamines, PCP

• OTHERS - Benzodiazepines, Barbiturates, Methadone

Features and Benefits of Oral Fluid Testing

The following are the feature of Oral fluid drug testing which even serves as the benefits to the donors:

• Cost Efficiency: The oral fluid is the interceptive test that minimizes or even eliminates the collection fees, reduces the scheduling issues and extensively reduces the lost work time. It costs a lot if the same test is conducted based the urine specimens.

• Control the Process: Oral fluid samples don’t require any special facilities. They can be collected by anytime and at anywhere. There are many alternative for collecting the specimens. It can be collected in a small conference room or in an office. This screening enables the donors to provide the samples and seal it easily, in few minutes. The laboratory reports negative results on the same day and the positive results are confirmed using GC/MS/MS and reports within 2-3 days.

• Adulteration: An oral fluid test can merely abolish the risks evolved in the adulteration. It is virtually impossible to mask the oral fluid samples with drug consumed. The oral fluid testing is often a direct observed system.

• Employee Dignity: The oral fluid test delivers a dignified, secured and evident collection method. The dignity of the collection method is an authentic benefit. It helps in making a good impression. As these are the tests conducted for your loved ones, or for your employees. As a result, this testing is a less embarrassing method to adopt.

Advantages of Oral Fluid Testing over Urine Tests:

Using well-proven technology, saliva tests offer several advantages over urine based tests:

• Oral fluid samples may be collected under direct supervision without donor privacy issues.

• Helps to eliminate sample adulteration.

• Sensitive and specific assays provide accurate test results.

• Non-invasive.

• Ideal for on-site testing. Test may be conducted anywhere and at anytime.

• No additional equipment or operator training required.

• The test kit includes all components like, instruction card to eliminate the errors.

The above information helps the individuals who want to test the drug screening in a simple and easy way.

The drug abuse remedies can be done in rehabilitation centers and curing centers. Thus, drug testing should be conducted in many places to examine the levels of drug usage. The drug abuse is raising many problems that are directly causing employee turnover, tardiness, absenteeism, theft, turnover, attitude problems, deceased productivity, crime and violence.

How the test is conducted?

Usually, drug testing is conducted by sending the candidate to a collection site, where a urine sample is obtained. This sample will be sent to a certified laboratory for analysis and results are available within 24 hours. There are instant test kits on the market, which are similar to home pregnancy tests. It involves the employer to manipulate a urine sample. Although these tests are considered accurate for immediate screening, they are useless in the event of a positive result, since that requires laboratory confirmation and retention of a sample for retesting by the subject. Moreover, they are much expensive then laboratory tests.

What is tested?

Usually, employers utilize the standard five-panel test, consisting of Marijuana, Cocaine, PCP, Opiates and Amphetamine. Few may use a ten-panel test, which includes prescription substances that are used and possessed legally. Employers can also test for alcohol. Virtually all drugs stay in the system for 2-4 days. For regular drug users, such results can be detected for up to 14 days and sometimes even more days. If the test is conducted through hair, then drugs can be detected for about 3 months. To avoid the obstacles from second hand marijuana smoke, many labs have set a higher threshold before reporting THC in the system.

What happens if there is a positive test or abnormal test?

Laboratory testing has an extensive process to confirm a positive test, before reporting. Many drug testing programs employ a physician called Medical Review Officer (MRO) to examine all test results. In certain cases, the test may be negative, but shows an abnormal result like, â??low creatine levelâ??. This denotes that the candidate have consumed excessive water or any alternative to dilute the sample. Though the test confirms the positive result, the program has the right to re-test the sample for their preference. For this purpose, the positive resulted test samples are retained.

The Pre-employment Drug Testing facilitates many employers to detect drug abuse among their employees, while screening them.