F.D.A. Approves Wyeth Antidepressant

Antidepressant drugs

Faced with the looming loss of patent protection for its top-selling drug, the antidepressant Effexor XR, Wyeth received federal approval on Friday for a successor drug, Pristiq, which the company hopes will also become a blockbuster.

With the Food and Drug Administration’s approval of Pristiq, Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

Wyeth needs a product that will replace some of the revenue expected to be lost to generic competitors of Effexor XR, whose patent protection expires in 2010. Sales of Effexor XR last year were $3.8 billion.

Dr. Philip Ninan, a Wyeth vice president for neuroscience, said he thought that Pristiq, which is chemically similar to Effexor, would have similar benefits in treating major depression. But the company said the drug had distinct advantages over its existing product.

Among them are that patients can start taking Pristiq at the therapeutic dose of 50 milligrams. Frequently, antidepressants must be started at a low dose, then ramped up to the therapeutic dose, to test whether patients can tolerate the drug and to determine the correct dose for the individual. Another advantage is that Pristiq does not have to be broken down by the liver, Dr. Ninan said, so it is not likely to interact with other medications metabolized by the liver.

“I think what’s important to understand in the depression category is that many patients fail to respond to anything that’s available,” said Geno Germano, Wyeth’s president of pharmaceuticals for the United States. “What’s important is that physicians and patients need multiple options available.”

But several analysts are skeptical of Pristiq, saying it has little advantage over other products on the market. And they raised questions about whether insurance companies would cover its cost in light of the availability of other drugs, including a less expensive generic version of Wyeth’s original version of Effexor that is already on the market.

Wyeth applied for F.D.A. approval of Pristiq in 2005. But in January 2007, the agency asked for additional information, a process that delayed approval until now.

During regular stock market trading on Friday, when most of the market was plunging, Wyeth’s shares were up more than 2.5 percent, closing at $43.62, in apparent anticipation of the F.D.A. approval.

Wyeth, based in Madison, N.J., has not yet announced how much Pristiq will cost. Effexor XR sells for about $120 for a 30-day supply, while the generic version of the original Effexor has been priced at less than half that recently on the Web site of one domestic chain pharmacy.

Dr. Timothy Anderson, a pharmaceutical analyst for Sanford C. Bernstein & Company, said that data Wyeth presented at a recent meeting of the American College of Neuropsychopharmacology failed to distinguish Pristiq from other marketed antidepressants.

“Payers are not likely to widely cover Pristiq in our view, and we forecast only low levels of sales,” Dr. Anderson wrote in a note to clients. He predicted the drug’s sales at $500 million by 2012, a relatively small figure in the antidepressant category.

And Dr. Daniel Carlat, a psychiatrist in Newburyport, Mass., who publishes the Carlat Psychiatry Report, said the release of Pristiq appeared mainly to be an effort by the company to, in effect, extend its patent for Effexor XR.

That is because Pristiq is a metabolite of Effexor — meaning it is the chemical compound that results after Effexor is swallowed and processed in the body.

“Is there a compelling public health reason for Wyeth to be releasing another antidepressant into the market, with no clear advantages over others?” Dr. Carlat said. “Not that I can see.”

Wyeth is also seeking F.D.A. approval for Pristiq as a drug to reduce hot flashes in menopause. The agency has asked for more data for that use.

Symptoms of High Blood Pressure

High Blood Pressure

High Blood Pressure Symptoms

Screening and prevention are the best ways to protect your health, since there are many symptoms of high blood pressure. At every check up, your doctor should measure your blood pressure. The average blood pressure is what your normal blood pressure measurement is. Taking it one time does not reflect your true average.

Lots of people don't notice or experience the symptoms of high blood pressure, even though they suffer from this condition. In many cases, someone could experience the high blood pressure symptoms but mistake them for the symptoms of some other disorder. But at some time or other, most people with high blood pressure will experience some of the following symptoms:

* Headache - This can be one of the biggest hints when it comes to high blood pressure symptoms. * Dizziness * Irritableness * Queasiness * Feeling Hot * Faintness

When high blood pressure is left untreated, it can cause many issues, like organ damage. Just a few of the examples of what high blood pressure can induce include eye damage and vision problems, stroke, aneurysms, and heart attack. It's important that if you have experienced any symptoms of high blood pressure that you contact your doctor immediately. This could be a life or death situation, and you need to get it under control. Even if you haven't experienced symptoms, if you have a history of high blood pressure in your family, you should get your blood pressure taken regularly to monitor arising problems.

You may also be able to help prevent high blood pressure problems and symptoms by eating a healthy diet, exercising, and avoiding alcohol and cigarettes. Prevention: That's the key to healthy and happy living. Take control of your life and your health.

Psychological drug tolerance, Sensitization

drug sensitization

The reward system is partly responsible for the psychological part of drug tolerance;

The CREB protein, a transcription factor activated by cyclic adenosine monophosphate (cAMP) immediately after a high, triggers genes that produce proteins such as dynorphin, which cuts off dopamine release and temporarily inhibits the reward circuit. In chronic drug users, a sustained activation of CREB thus forces a larger dose to be taken to reach the same effect. In addition it leaves the user feeling generally depressed and dissatisfied, and unable to find pleasure in previously enjoyable activities, often leading to a return to the drug for an additional "fix".

Sensitization is the increase in sensitivity to a drug after prolonged use. The proteins delta FosB and regulator of G-protein Signaling 9-2 (RGS 9-2) are thought to be involved:

A transcription factor, known as delta FosB, is thought to activate genes that, counter to the effects of CREB, actually increase the user's sensitivity to the effects of the substance. Delta FosB slowly builds up with each exposure to the drug and remains activated for weeks after the last exposure—long after the effects of CREB have faded. The hypersensitivity that it causes is thought to be responsible for the intense cravings associated with drug addiction, and is often extended to even the peripheral cues of drug use, such as related behaviors or the sight of drug paraphernalia. There is some evidence that delta FosB even causes structural changes within the nucleus accumbens, which presumably helps to perpetuate the cravings, and may be responsible for the high incidence of relapse that occur in treated drug addicts.

Regulator of G-protein Signaling 9-2 (RGS 9-2) has recently been the subject of several animal knockout studies. Animals lacking RGS 9-2 appear to have increased sensitivity to dopamine receptor agonists such as cocaine and amphetamines; over-expression of RGS 9-2 causes a lack of responsiveness to these same agonists. RGS 9-2 is believed to catalyze inactivation of the G-protein coupled D2 receptor by enhancing the rate of GTP hydrolysis of the G alpha subunit which transmits signals into the interior of the cell.

Drugs causing addiction

Drugs causing addiction

Drugs known to cause addiction include illegal drugs as well as prescription or over-the-counter drugs.

* Stimulants:
o Amphetamine and Methamphetamine;
o Caffeine;
o Cocaine;
o Nicotine.

* Sedatives and Hypnotics:
o Alcohol;
o Barbiturates;
o Benzodiazepines, particularly alprazolam, clonazepam, temazepam, and nimetazepam;
o Methaqualone and the related quinazolinone sedative-hypnotics;
o GHB and analogues (specifically GBL).

* Opiate and Opioid analgesics;
o Morphine and Codeine, the two naturally-occurring opiate analgesics;
o Semi-synthetic opiates, such as Heroin (Diacetylmorphine), Oxycodone, and Hydromorphone;
o Fully synthetic opiods, such as Fentanyl and its analogs, Meperidine/Pethidine, and Methadone;
* Anabolic steroids.

Addictive drugs also includes a large number of substrates that are currently considered to have no medical value and are not available over the counter or by prescription.

The legality of psychoactive drugs

legality of psychoactive drugs

The legality of psychoactive drugs has been controversial through most of history; the Opium Wars and Prohibition are two historical examples of legal controversy surrounding psychoactive drugs. However, in recent years, the most influential document regarding the legality of psychoactive drugs is the Single Convention on Narcotic Drugs, an international treaty signed in 1961 as an Act of the United Nations. Signed by 73 nations including the United States, the USSR, India, and the United Kingdom, the Single Convention on Narcotic Drugs established Schedules for the legality of each drug and laid out an international agreement to fight addiction to recreational drugs by combatting the sale, trafficking, and use of scheduled drugs. All countries that signed the treaty passed laws to implement these rules within their borders. However, some countries that signed the Single Convention on Narcotic Drugs, such as the Netherlands, are more lenient with their enforcement of these laws.

In the United States, the Food and Drug Administration (FDA) has authority over all drugs, including psychoactive drugs. The FDA regulates which psychoactive drugs are over the counter and which are only available with a prescription. However, certain psychoactive drugs, like alcohol, tobacco, and drugs listed in the Single Convention on Narcotic Drugs are subject to criminal laws. The Controlled Substances Act of 1970 regulates the recreational drugs outlined in the Single Convention on Narcotic Drugs. Alcohol is regulated by state governments, but the federal National Minimum Drinking Age Act penalizes states for not following a national drinking age. Tobacco is also regulated by all fifty state governments. Most people accept such restrictions and prohibitions of certain drugs, especially the "hard" drugs, which are illegal in most countries.

In the medical context, psychoactive drugs as a treatment for illness is widespread and generally accepted. Little controversy exists concerning over the counter psychoactive medications in antiemetics and antitussives. Psychoactive drugs are commonly prescribed to patients with psychiatric disorders. However, certain critics believe that certain prescription psychoactives, such as antidepressants and stimulants, are overprescribed and threaten patients' judgement and autonomy.

Uses of psychoactive substances

psychoactive substances

Psychoactive substances are used by humans for a number of different purposes, both legal and illicit.


General anesthetics are a class of psychoactive drug used on patients to block pain and other sensations. Most anesthetics induce unconsciousness, which allows patients to undergo medical procedures like surgery without physical pain or emotional trauma. To induce unconsciousness, anesthetics affect the GABA and NMDA systems. For example, halothane is a GABA agonist, and ketamine is an NMDA receptor antagonist.


Psychoactive drugs are often prescribed to manage pain. As the subjective experience of pain is regulated by endorphins, neurochemicals that are endogenous opioids, pain can be managed using psychoactives that operate on this neurotransmitter system. This class of drugs includes narcotics, like morphine and codeine, and also NSAIDs such as aspirin and ibuprofen.

Psychiatric medications

Psychiatric medications are prescribed for the management of mental and emotional disorders. There are 6 major classes of psychiatric medications:

* Antidepressants, which are used to treat disparate disorders such as clinical depression, dysthymia, anxiety, eating disorders and borderline personality disorder.
* Stimulants, which are used to treat disorders such as attention deficit disorder and narcolepsy and to suppress the appetite.
* Antipsychotics, which are used to treat psychoses such as schizophrenia and mania.
* Mood stabilizers, which are used to treat bipolar disorder and schizoaffective disorder.
* Anxiolytics, which are used to treat anxiety disorders.
* Depressants, which are used as hypnotics, sedatives, and anesthetics.

Recreational drugs

Many psychoactive substances are used for their mood and perception altering effects, including those with accepted uses in medicine and psychiatry. Classes of drugs frequently used recreationally include:

* Stimulants, which elevate the central nervous system. These are used recreationally for their euphoric and performance-enhancing effects.
* Hallucinogens, which induce perceptual and cognitive distortions.
* Hypnotics, which are used recreationally to because they induce inebriation.
* Analgesics, which are used recreationally because of their euphoric effects.

Examples include caffeine, alcohol, cocaine, LSD, and cannabis.

In many cultures, possessing or having used recreational drugs is seen as a status symbol. Recreational drugs, especially those known as club drugs, are seen as status symbols at social events such as at nightclubs and parties. This is true of many cultures throughout history; drugs have been viewed as status symbols since ancient times. For example, in ancient Egypt, gods were commonly pictured holding hallucinogenic plants.

Psychoactive drugs

Psychoactive drugs

A psychoactive drug or psychotropic substance is a chemical substance that acts primarily upon the central nervous system where it alters brain function, resulting in temporary changes in perception, mood, consciousness and behavior. These drugs may be used recreationally to purposefully alter one's consciousness, as entheogens for ritual or spiritual purposes, as a tool for studying or augmenting the mind, or therapeutically as medication.

Because psychoactive substances bring about subjective changes in consciousness and mood that the user may find pleasant (e.g. euphoria) or advantageous (e.g. increased alertness), many psychoactive substances are abused, that is, used excessively, despite risks or negative consequences. With sustained use of some substances, physical dependence may develop, making the cycle of abuse even more difficult to interrupt. Drug rehabilitation can involve a combination of psychotherapy, support groups and even other psychoactive substances to break the cycle of dependency.

In part because of this potential for abuse and dependency, the ethics of drug use are the subject of a continuing philosophical debate. Many governments worldwide have placed restrictions on drug production and sales in an attempt to decrease drug abuse.

How should I take acetaminophen, aspirin, and caffeine?

symptoms aspirin

Take acetaminophen, aspirin, and caffeine exactly as directed by your doctor or follow the instructions on the package. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.

Take each tablet or capsule with a full glass of water to ensure adequate swallowing of the medication.

Do not take more acetaminophen, aspirin, and caffeine than is directed. Too much acetaminophen, aspirin, and caffeine may be harmful.

If your symptoms do not improve, or if they get worse, stop using acetaminophen, aspirin, and caffeine and contact your doctor.

Due to the caffeine in this product, taking acetaminophen, aspirin, and caffeine before bed may result in difficulty sleeping.
Store acetaminophen, aspirin, and caffeine at room temperature away from heat and moisture.

Before taking acetaminophen, aspirin, and caffeine

aspirin and caffeine

What should I discuss with my healthcare provider before taking acetaminophen, aspirin, and caffeine?

Do not drink alcohol during treatment with acetaminophen, aspirin, and caffeine. Together, alcohol, acetaminophen, and aspirin can be damaging to the liver and stomach. If you drink more than three alcoholic beverages a day, talk to your doctor before taking acetaminophen, aspirin, and caffeine.

Before taking this medication, tell your doctor if you:

* have an allergy to or have had problems after taking aspirin;
* have an allergy to or have had problems after taking a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Naprosyn, Anaprox, others), indomethacin (Indocin), ketoprofen (Orudis KT, Orudis, Oruvail), nabumetone (Relafen), oxaprozin (Daypro), and others;
* drink more than three alcoholic beverages a day;
* have never had migraines diagnosed by a doctor;
* have a headache that is different from or more severe than your usual migraines;
* have daily headaches;
* have a headache following or caused by a head injury, exertion, coughing, or bending;
* experienced your first headache after age 50;
* have an ulcer or bleeding in the stomach;
* have liver disease;
* have kidney disease;
* have a bleeding or blood clotting disorder (e.g., hemophilia);
* have high blood pressure;
* have gout;
* have asthma;
* have nasal polyps;
* have anxiety problems or insomnia.

You may not be able to take acetaminophen, aspirin, and caffeine or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether acetaminophen, aspirin, and caffeine will be harmful to unborn baby. However, it is known that aspirin taken during pregnancy may affect an unborn baby’s heart, reduce birth weight, and have other dangerous effects on the unborn baby. Do not take acetaminophen, aspirin, and caffeine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Acetaminophen, aspirin, and caffeine may affect a nursing baby. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby.

Do not use acetaminophen, aspirin, and caffeine to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to the child’s doctor. In children younger than 18 years of age, aspirin may increase the risk of Reye"s syndrome, a rare but often fatal condition.

What is acetaminophen, aspirin, and caffeine?

pain relief caplets

Acetaminophen is a pain reliever and a fever reducer.

Aspirin is in a class of drugs called salicylates. It works by reducing substances in the body that cause pain and inflammation.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen and aspirin.

Together, acetaminophen, aspirin, and caffeine are used to treat pain from conditions such as headache (including migraine), muscle aches, menstrual cramps, arthritis, backache, toothaches, colds and sinus infections.

Acetaminophen, aspirin, and caffeine may also be used for purposes other than those listed in this medication guide.

Legal definition of drugs

Some governments define the term drug by law. In the United States, the Federal Food, Drug, and Cosmetic Act definition of "drug" includes "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals." Consistent with that definition, the U.S. separately defines narcotic drugs and controlled substances, which may include non-drugs, and explicitly excludes tobacco, caffeine and alcoholic beverages.

The use of drugs, the possession or distribution of which is unlawful under the Controlled Substances Act. Such term does not include the use of a drug taken under supervision by a licensed health care professional, or other uses authorized by the Controlled Substances Act or other provisions of Federal law. 29 USC

1. A substance used in the diagnosis, treatment, or prevention of a disease or as a component of a medication.
2. Such a substance as recognized or defined by the US Food and Drug Administration.
3. A chemical substance, such as a narcotic or hallucinogen, that affects the central nervous system, causing changes in behavior and often addiction.
4. To administer a drug, especially in an overly large quantity, to an individual.
5. To stupefy or dull with or as if with a drug to narcotize.

Recreation and spiritual. Nootropics

Recreational drugs use is the use of psychoactive substances to have fun, for the experience, or to enhance an already positive experience. National laws prohibit the use of many different recreational drugs and medicinal drugs that have the potential for recreational use are heavily regulated. Many other recreational drugs on the other hand are legal, widely culturally accepted, and at the most have an age restriction on using and/or purchasing them. These include alcohol, tobacco, betel nut, and caffeine products.

The spiritual and religious use of drugs has been occurring since the dawn of our species. Drugs that are considered to have spiritual or religious use are called entheogens. Some religions are based completely off of the use of certain drugs. Entheogens are mostly hallucinogens, being either psychedelics or deliriants, but some are also stimulants and sedatives.

Nootropics, also commonly referred to as "smart drugs", are drugs that are claimed to improve human cognitive abilities. Nootropics are used to improve memory, concentration, thought, mood, learning, and many others things. Some nootropics are now beginning to be used to treat certain diseases such as attention-deficit hyperactivity disorder, Parkinson's disease, and Alzheimer's disease. They are also commonly used to regain brain function lost during aging.

Drugs medication

A medication or medicine is a drug taken to cure and/or ameliorate any symptoms of an illness or medical condition, or may be used as preventive medicine that has future benefits but does not treat any existing or pre-existing diseases or symptoms.

Dispensing of medication is often regulated by governments into three categories — over-the-counter (OTC) medications, which are available in pharmacies and supermarkets without special restrictions, behind-the-counter (BTC), which are dispensed by a pharmacist without needing a doctor's prescription, and Prescription only medicines (POM), which must be prescribed by a licensed medical professional, usually a physician.

In the UK, BTC medicines are called pharmacy medicines which can only be sold in registered pharmacies, by or under the supervision of a pharmacist.[citation needed] However, the precise distinction between OTC and prescription drugs depends on the legal jurisdiction.

Medications are typically produced by pharmaceutical companies and are often patented to give the developer exclusive rights to produce them, but they can also be derived from naturally occurring substance in plants called herbal medicine. Those that are not patented (or with expired patents) are called generic drugs since they can be produced by other companies without restrictions or licenses from the patent holder.

Drugs, both medicinal and recreational, can be administered in a number of ways:

* Orally, as a liquid or solid, that is absorbed through the stomach.
* Inhaled, (breathed into the lungs), as a vapor.
* Injected as a liquid either intramuscular or intravenous (put under the skin, into a vein or muscle tissue with the use of a hypodermic needle).
* Rectally as a suppository, that is absorbed by the colon.
* Vaginally as a suppository, primarily to treat vaginal infections.
* Bolus, a substance into the stomach to dissolve slowly.
* Insufflation, or snorted into the nose.

Many drugs can be administered in a variety of ways.

Major Drug Groups

Gastrointestinal tract (A)

• Antacids;
• Antiemetics;
• H2 antagonists;
• Proton pump inhibitors;
• Laxatives;
• Antidiarrhoeals.

Blood and blood forming organs (B)

• Anticoagulants;
• Antiplatelets;
• Thrombolytics.

Cardiovascular system (C)

• Antiarrhythmics;
• Antihypertensives;
• Diuretics;
• Vasodilators;
• Antianginals;
• Beta blockers;
• Angiotensin converting enzyme inhibitors;
• Antihyperlipidemics.

Skin (D)

• Emollients - Antipruritics.

Reproductive system (G)

• Hormonal contraception;
• Fertility agents;
• Selective estrogen receptor modulators;
• Sex hormones.

Endocrine system (H)

• Anti-diabetics;
• Corticosteroids;
• Sex hormones;
• Thyroid hormones.

Infections and Infestations (J, P)

• Antibiotics;
• Antivirals;
• Vaccines;
• Antifungals;
• Antiprotozoals;
• Anthelmintics.

Malignant and Immune disease (L)

• Anticancer agents;
• Immunostimulators;
• Immunosuppressants.

Muscles, Bones, and Joints (M)

• Anabolic steroids;
• Anti-inflammatories;
• Antirheumatics;
• Corticosteroids;
• Muscle relaxants.

Brain and Nervous system (N)

• Anesthetics;
• Analgesics;
• Anticonvulsants;
• Mood stabilizers;
• Anxiolytics;
• Antipsychotics;
• Antidepressants;
• Nervous system stimulants;
• Sedatives.

Respiratory system (R)

• Bronchodilators;
• Decongestants;
• H1 antagonists.

Drugs defining

In pharmacology, Dictionary.com defines a drug as "a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being." Drugs may be prescribed for a limited duration, or on a regular basis for chronic disorders.

Recreational drugs are chemical substances that affect the central nervous system, such as narcotics or hallucinogens. They may be used for perceived beneficial effects on perception, consciousness, personality, and behavior. Some recreational drugs can cause addiction and habituation.

Drugs are usually distinguished from endogenous biochemicals by being introduced from outside the organism. For example, insulin is a hormone that is synthesized in the body; it is called a hormone when it is synthesized by the pancreas inside the body, but if it is introduced into the body from outside, it is called a drug.

Many natural substances such as beers, wines, and some mushrooms, blur the line between food and drugs, as when ingested they affect the functioning of both mind and body.