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Vicodin: Prescription Drug Abuse & Testing

Drugstestproduct — Mon, 27 Dec 2010 10:59:59 +0000

Vicodin is a derivative of opium, which also used to manufacture heroin. It is the most widely known brand name for a combination of hydrocodone and acetaminophen. Some of its generic equivalents include brand names Lorcet, Lortab, Norco, Panacet and Zydone.

Vicodin Prescription:

Vicodin is one of the most widely prescribed opiate medications for treatment of moderate to severe pain in injury, illness, surgery or a chronic condition across the globe. Overall, it has been reported as an effective, well tolerated opioid for analgesic purposes. It is quite inexpensive, with a mild side effects profile. It is one of the most favored prescribed pain relievers as allergic reactions are highly unlikely with Vicodin.

Vicodin Abuse:

It is estimated that in 1999, 4 million people were using prescription drugs non-medically and out of these 4 million, 2.6 million misused pain relievers the most common of which is Vicodin. In 2000, the National Institute on Drug Abuse listed Vicodin as an emerging recreational drug. Its use has risen steadily each year, and has now achieved the status of no longer being emerging. Vicodin has become one of the most commonly abused prescription medications. In 2006, USA Today reported that more emergency room visits are made by Vicodin and other prescription drugs abusers than by all other illicit drug abusers combined.

Effects of Vicodin Abuse:

Some of the common side effects of Vicodin abuse include confusion, nausea, vomiting, lightheadedness, dizziness, drowsiness, redness of the face, and temporary changes in vision or mood, along with infrequent constipation. These effects can be subdued by drinking a lot of water and consuming fiber rich foods on daily basis.

Over a period of time, effects of Vicodin abuse become more serious and more damaging. There may be cardiac arrhythmia leading to speeding up or slowing down of the heart rate. As Vicodin use grows, its effects can be characterized by blurred vision, hallucinations, and severe confusion.

Vicodin may interact with many other drugs if taken in conjunction, like, various sedatives, tranquilizers, antidepressants, other analgesics, antihistamines, anti-anxiety & anti-spasmodic drugs to name a few. Because of this high potential for drug interactions, it is highly recommended to avoid alcohol, which can increase drowsiness and dizziness, and may cause damage to the liver, and other medications containing acetaminophen.

As with other Opiate drugs, Vicodin withdrawal symptoms include restlessness, muscle pain, bone pain, insomnia, diarrhea, vomiting, cold flashes, goose bumps, involuntary leg movements, watery eyes, runny nose, loss of appetite, irritability, panic, nausea, chills & sweating to name a few.

Vicodin Testing:

When consumed, some amount of Vicodin remains unchanged in the body while rest of it is metabolized to different secondary products called metabolites. A diverse array of techniques is available nowadays to detect these unchanged Vicodin or Vicodin metabolites, such as:

•Blood sampling for Vicodin/metabolite testing

•Urine based Vicodin/metabolite testing

•Hair follicle based Vicodin/metabolite detection

•GC/MS based Vicodin/metabolite detection

•Vicodin/metabolite-specific antibody based diagnostic kits

GC/MS or Antibody based screening can be done on any of the blood, urine or hair follicle samples. Some companies have also come out with rapid screening kits for home use which can be used without any previous expertise.

Demerol: Prescription Drug Abuse & Testing

Drugstestproduct — Sun, 26 Dec 2010 08:44:59 +0000

Demerol is the trade name of Pethidine / meperidine which is a fast-acting opioid analgesic drug used to treat pain. In the United States and Canada, Pethidine or meperidine is more commonly known by its brand name Demerol whereas in many parts of the world, it is also known as isonipecaine; lidol; pethanol; piridosal; Algil; Alodan; Centralgin; Demerol; Dispadol & Dolantin etc.

Chemically, Demerol is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-ethyl ester hydrochloride.

Demerol Prescription, Dosage & Administration:

Demerol, a narcotic analgesic, is prescribed for the relief of moderate to severe pain. Dosage is adjusted by physician according to the severity of the pain and the response of the patient. The oral solution is often a pleasant-tasting, nonalcoholic solution containing 50 mg of meperidine hydrochloride per 5ml teaspoon. The tablets usually contain 50 mg or 100 mg of the analgesic. It is delivered as its hydrochloride salt in tablets, as a syrup, or by intramuscular or intravenous injection although it is less effective orally than on parenteral administration (as by intramuscular or intravenous injection).

Demerol Abuse:

Demerol contains meperidine, a mu-agonist opioid with an abuse liability similar to morphine and is a controlled substance. Abuse of Demerol poses a risk of overdose and death. This risk is increased with concurrent abuse of Demerol with alcohol and other substances. Intramuscular or intravenous abuse of crushed tablets can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart disease. In addition, such sort of drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Effects of Demerol Abuse:

The major hazards of Demerol, as with other narcotic analgesics, are respiratory depression and to a lesser degree, circulatory depression; respiratory arrest, shock, and cardiac arrest etc.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, vomiting, nausea, & sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.

Miscellaneous:

There is a category of drugs called MAO Inhibitors. Drugs in this category include the antidepressants phenelzine & tranylcypromine. If you are taking these antidepressants or have used them in last 2-3 weeks, inform your physician well in advance because when taken with Demerol, these MAO Inhibitors can cause unpredictable, severe, & occasionally fatal reactions.

The narcotic antagonist, naloxone hydrochloride, is a specific antidote against respiratory depression which may result from over dosage or unusual sensitivity to narcotics, including meperidine. Therefore, an appropriate dose of this antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.

Demerol Testing:

A diverse array of techniques is available to test for drug abuse and Demerol or Pethidine/meperidine containing compounds are no exception. As with other drugs, some amount of Pethidine/meperidine remains unchanged while rest of it forms different metabolites.

These unchanged Pethidine or meperidine compounds and their metabolized products can be detected using any of the following methods:

•Urine based Pethidine/meperidine/metabolite testing

•Hair follicle based Pethidine/meperidine/metabolite detection

•GC based Pethidine/meperidine/metabolite detection

•Mass spec based Pethidine/meperidine/metabolite testing

•Pethidine/meperidine/metabolite-specific antibody based diagnostic kits

Recent Laws and Regulations Regarding Drug Paraphernalia Ownership

Drugstestproduct — Sun, 19 Dec 2010 08:25:57 +0000

Are you aware of different drug paraphernalia? If you are aware of all of them, it does not mean that you are a drug user or a drug addict. It just means that you are aware of what is happening around you.

To those people who are not familiar with this, drug paraphernalia are different things or equipment that are use in making and using illegal drugs like cocaine, marijuana, methamphetamine and heroin. There are two different kinds of drug paraphernalia:

• User-specific products – these kinds of products are sold to drug users in order to perform the activity well. Some of these products are pipes, masks, clips and other things in order to hide the illegal drugs.

• Dealer Specific products – these kinds of products are used by drug traffickers. They use this product when they already distribute the illegal drugs to different people. Sample of this products are scale, baggies and vials.

According to the law, it is illegal to possess the said paraphernalia. Actually, not only possess but also to transport, sell, and import or export these kinds of things. The law is providing guidelines to determine if the paraphernalia is used in illegal drugs or not.

How about the sales of drug paraphernalia? Way back in 1960s up to 1970s in the United States, the selling of drug paraphernalia was very obvious. During those times, you could see many shops selling different drug paraphernalia. You will also find home-made paraphernalia. Some people even sold them on the street which a lot of people could see. Nowadays, people can’t sell their products on the street and other places like stores but how about the internet?

Things you should know

There are some important things that you should know about drug paraphernalia. Here are some of them:

• The target market of drug paraphernalia is the youth. A lot of teenagers are addicted to illegal drugs due to many reasons. Some reason may be personal like family problems or financial problems. Some reason might be their friends. Peer pressure can do a lot of things.

• Drug paraphernalia are packaged with different pictures, designs, etc. so that it will not be obvious. Some example designs are colorful logos, pictures of famous people like celebrities and different smiley faces.

• Drug paraphernalia like markers can cover up pipes and other small glasses that are hand painted.

Unfortunately, a lot of parents do not know these. Parents should know about these things. This is one of the biggest problems in a society. For some government officials, they were successful in beating up this kind of problem but sometimes, no matter what they do, they are like just mushrooms that keep on coming back. Drug paraphernalia might be simple but it can give great impact to the society and especially to the youth. Not really good to our ears, right? But it’s the reality.

Oxycontin: Prescription Drug Abuse & Testing

Drugstestproduct — Sat, 18 Dec 2010 10:36:41 +0000

OxyContin is an opium derivative, which contains the same active ingredient as in Percodan and Percocet. OxyContin is a very strong narcotic pain reliever similar to morphine. OxyContin is designed so that its oxycodone salt is slowly released over time. OxyContin products are in schedule II of the federal Controlled Substances Act of 1970 in United States.

OxyContin Prescription:

OxyContin is an opiate agonist that provides pain relief by acting on opioid receptors in the spinal cord, brain, and possibly in the tissues directly. Opioids, natural or synthetic classes of drugs that act like morphine have been recognized as the most effective pain relievers available and thus OxyContin is prescribed for moderate to high pain relief associated with injuries, bursitis, dislocation, fractures, neuralgia, arthritis, and lower back pain. It is also used after surgeries and for pain relief after childbirth. It is a commonly used medication for pain relief in cancer patients.

OxyContin Abuse in U.S.:

The power painkiller OxyContin is being abused by more and more people across United States. The heroin-like effects of the drug attract both legitimate and illegitimate users. Although the diversion and abuse of OxyContin appeared initially in the eastern U.S., it has now spread to the western U.S. including Alaska and Hawaii. As a result, OxyContin-related adverse health effects increased markedly in recent years.

OxyContin abused is increasing rapidly due to many factors:

•It contains high levels of opium which makes it highly addictive.

•OxyContin is not laced with other conjugates so an addict can decide exactly how much of the drug is required to get that high.

•OxyContin is significantly cheaper than street drugs. No wonder, OxyContin is widely referred to as the poor man’s heroin.

Most individuals who abuse OxyContin seek the euphoric effects to mitigate pain and to avoid withdrawal symptoms associated with opium abstinence.

Effects of OxyContin Abuse:

Chief hazard from all opioid usage is the respiratory depression and OxyContin is no exception. Respiratory depression occurs mostly in elderly or debilitated patients, often following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Other than respiratory depression, some serious adverse reactions that may be associated with OxyContin use include apnea, respiratory arrest, circulatory depression, and hypertension. It may also cause a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Delayed digestion of food in the small intestine and a subsequent decrease in propulsive contractions has also been reported.

Some common side effects of OxyContin are constipation, nausea, sedation, dizziness, vomiting, headache, dry mouth, sweating, and weakness.

OxyContin Testing:

OxyContin can be detected in urine testing within one or two days following drug exposure although hair follicle based drug analysis may even be performed at longer intervals.

Laboratory testing may involve Antibody based screening assays or Chromatographic procedures. A Mass spectrometric screening can also be done for further validation purposes. However, preliminary evaluation of patients or periodic monitoring can be done by one of those easy-to-use kits which usually work on the principles of specific antigen-antibody interactions.

Glucose (blood) Tests-drug

Drugstestproduct — Fri, 17 Dec 2010 09:02:23 +0000

How the Drug Works

Specially treated test strips indicate the blood glucose concentration. Regular monitoring of glucose aids in the control of diabetes. It will help determine medication, dietary and exercise needs and help decrease the complications (eg, neuropathies, retinopathies) and problems during pregnancy.

Uses

To monitor blood glucose levels In diabetics. To aid in control of the condition.

To aid in determining medication regimes, diet, and exercise programs for diabetics.

To help prevent development of complications during pregnancy.

Specimen Collection and Handling: All blood glucose test strips require a finger or earlobe stick. An automatic lancet device punctures the skin to obtain a single drop of blood. A manual lancet is more painful and laceration size and puncture depth cannot be predicted. These are important because they control the volume of the drop of blood. The size of the test pad varies among manufacturers. It must be completely covered with blood.

A single drop of blood is placed on the test strip. Begin timing when the test pad is covered completely. In some tests, the blood drop is wiped from the test strip at the end of the timed period. Timing is critical. The wiping or blotting technique and the recommended tissue paper or cotton for blotting may vary by manufacturer. The test strip is placed in the glucose meter. The results are read from the meter display. The visual test is read against the color key.

Storage and handling: A bottle of test strips can be used for 4 months after being opened. Always write the date the bottle is first opened on the bottle label. Never use the test strips past the expiration date indicated on the bottle label or foil packet. Use of strips beyond the expiration date may yield inaccurate results.

Keep unused test strips in the original bottle with cap tightly closed. Always replace the cap immediately and tightly. Never transfer test strips to another bottle. Leave the drying agent in the bottie. The drying agent absorbs moisture and keeps the strips dry. Never put cotton or other material in the bottle. Do not use discolored strips. Keep your fingers or other objects from touching the test pads before testing. Touching the pads could cause inaccurate test results.

Keep strip vial away from small children. A child could choke on the cap or drying agent, which could be harmful if swallowed. Store at room temperature (59° to 86°F). Do not store bottle in direct sunlight. Do not freeze. Do not store in cabinets with bleach or products containing bleach.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any overthe-counter or prescription medications or dietary supplements while testing for blood glucose. The following drugs and drug classes may interact with the test to cause questionable results:

Acetaminophen (eg, Tylenol)

Fluoride

Aspirin (large amounts)

Methyldopa (large amounts)

Dopamine (large amounts)

Vitamin C

Guidelines for Use

Follow instructions on the label exactly.

Monitor blood for glucose as prescribed. Monitor urine ketones if your blood glucose level has been greater than 300 mg/dL for 2 consecutive blood glucose determinations.

Blood glucose monitoring is recommended to achieve normal blood sugar levels. Keep track of your blood glucose results so that adjustments in your treatment program can be made more easily.

Participate in a thorough diabetes education program so that you understand diabetes and all aspects of its treatment, including diet, exercise, personal hygiene and how to self-monitor blood glucose.

Apply the blood drop, time the reaction, blot the test pads and read the test results the same way each time you do the test.

Diabetics – Monitor glucose: When you have a cold, the flu or any other kind of illness. When you “feel” the signs of low or high blood sugar (greater than 240 mg/dL) or when your blood sugar is well over the range your doctor has set for you (if you do blood glucose monitoring). When you are under unusual physical or emotional stress. During pregnancy or after a testing pattern has been established with your doctor or educator.

Have all the materials you need before beginning the test: Test strips, timer (stop watch or watch with a second hand), sterile lancet, cotton or rayon balls, alcohol wipes, and glucose meter.

Color vision is needed to properly read visual, but not meter, test results. Have someone else confirm the visual test results if in doubt.

Quality control and sample tests may be required before testing.

If test results seem questionable, check expiration date on the label, repeat the test using a new test strip, run controls, check glucose meter and check procedure (timing).

If you are unable to identify the cause of a low or high test result, contact your doctor or diabetes educator. Know the symptoms of hypergly cemia (high blood sugar), which include thirst, hunger and frequent and excessive urination and those of hypoglycemia (low blood sugar), which include trembling, sweating, blurred vision, rapid heartbeat, and tingling or numbness around mouth or fingertips.

If you experience stomach pain, vomiting or difficulty breathing, contact your doctor immediately.

Individuals with high uric acid, bilirubin cholesterol, triglyceride or hematocrit levels may have lowered glucose levels.

Diabetes education may be obtained through your local chapter of the American Diabetes Association.

Do We Really Need To Have Animal Testing?

Drugstestproduct — Sun, 05 Dec 2010 00:00:51 +0000

Do we really need to have animal testing?

Is it really necessary that we have animal testing to make our lives better? When do we say no? Is there a difference between testing on mice and testing on dogs or monkey’s? Can’t we live happily without these tests?

Is it Ever Acceptable?

Animal testing is always a touchy subject. I generally find myself on the wrong end of both sides of the argument as I disagree with animal testing on what I consider non-vital experiments like make-up products and cosmetic medicines (medicines for symptoms that are not critical or dangerous). But when it comes to life saving drugs, I believe they must be tested before being introduced into the open market. The thought of an AIDS cure that has not been tested is a scary prospect, is it could lead to a cure causing unexpected complications and leaving the patient in a worse condition than before the treatment.

The Reason behind Animal Testing

Animal testing is done for the development of effective and safe drugs for mankind. Animal research in fact plays a vital role in virtually every major medical research and development process. The reason behind animal testing stems from the fact that this type of research offers valuable insights into the working of the human systems. Moreover health agencies and medical societies around the world recognize the need for animal testing. Tests are carried out on animals carrying a particular disease as part of the animal testing process. There are also instances when animals are created with certain types of disorders in order to test certain type of drugs too.

Everyone has it’s own life

Life is equal whatever who it is. Dogs, cats, rabbits, horses, sheep, even ants have their own life. As long as they have their consciousness, they should be respected totally, especially the animals who can communicate with human like dogs, monkeys and so on.

However, in the Medical research institutions, someone take animals testing to prove how effective about some new medicine. The mousses and rabbits are often the victims. Who can consider their feelings? All about these is so horrible.

There are many ways to improve the development of medical. Did it must take some innocent life away? Is it fair for them? Why human must so selfish to get the advantage from other lives? We are all members of the nature. Let’s learn to respect the other animals who living with us together on the earth.

Carcinogen Found in Popular Products

Drugstestproduct — Mon, 29 Nov 2010 10:46:31 +0000

In early 2007, a cancer-causing petrochemical was found in dozens of children’s bath

products and adults’ personal care products, in some cases at levels more than twice the U.S. Food and Drug Administration’s (FDA) recommended maximum.Laboratory tests revealed the presence of 1,4-Dioxane in products such as Hello Kitty Bubble Bath, Huggies Baby Wash, Johnson’s Baby Wash, Scooby-Doo Bubble Bath and Sesame Street Bubble Bath. The tests also found the carcinogen in Clairol Herbal Essences shampoo, Olay Complete Body Wash and many other products for adults.1,4-Dioxane is a petroleum-derived contaminant considered a human carcinogen by the U.S. Environmental Protection Agency and the National Toxicology Program. It is also on California’s Proposition 65 list of chemicals linked to cancer and birth defects. But because it is produced during manufacturing, the FDA does not require it to be listed as an ingredient on product labels. Also, the agency has little authority or enforcement capacity over the cosmetics industry.

The FDA has been measuring 1,4-Dioxane levels since 1979 and is working with manufacturers to reduce levels on a voluntary basis. In 2000, the FDA recommended that cosmetic products not contain 1,4-Dioxane at concentrations greater than 10 parts per million; yet 15% of products tested exceeded these guidelines. This limit, however, also does not take into account that people exposed to 1,4-Dioxane from shampoo may be exposed at the same time to 1,4-Dioxane from bubble bath, body wash and other products.The tests were conducted by West Coast Analytical Service, an independent testing laboratory specializing in trace chemical analysis, and results were announced by the Campaign for Safer Cosmetics.

Cholesterol – Panel Testing, Diet & Medication

Drugstestproduct — Fri, 26 Nov 2010 01:04:10 +0000

Ways to monitor & reduce blood cholesterol levels…

Cholesterol testing helps a lot in understanding the on-set cascades of several cardiovascular & degenerative diseases. There are several techniques to monitor & regulate cholesterol levels in serum. These include various non-invasive methods, like Laser cholesterol testing in which a laser is reflected upon patient’s eyes to determine the cholesterol levels, as well techniques like digital panel testing which are widely preferred across the globe.

Cholesterol Panel testing involves assessing of cholesterol levels directly from the blood samples taken from the patients and are analyzed on specialized strips, especially designed for the purpose. These strips, with blood samples on them, can either be checked directly on machines or can be sent to labs with proper specifications and credentials.

One can opt for dietary therapies and/or various medications in order to lower the cholesterol levels in the blood:

• Dietary therapy: In this therapy, diet and lifestyles are modified in order to reduce the intake of cholesterol. These modifications are promoted as a prudent, an inexpensive, and a safe way to reduce the risk of cardiovascular, degenerative & other cholesterol associated diseases.

Dietary therapy has multi-facet advantages. A DASH (Dietary Alternatives to Stop Hypertension) study has shown that additional servings of vegetables, fruit, and low-fat dairy products produce belittled but significant reductions in blood pressure. Various reports suggest limiting daily calories from saturated fats to the 7-10% of the total calorific intake. Cholesterol intake should be limited to 200 to 300 mg per day.

Dietary therapy has been the primary treatment for hypercholesterolemia because of low risk of side effects, high benefits.

• Medication/Drug therapy: Various medicines or counter-drugs are available in the market which can be used for reducing the blood cholesterol levels. One such drug is Statin, 3-hydroxy-3-methylglutaryl, a laboratory synthesized chemical, which dissembles the coenzymeA reductase class of cholesterol reducing compounds. These drugs are quite in vogue but they do have some side effects.

Drug therapies are reported to have more profound effects than to dietary therapy. A 24% reduction in LDL has been observed by drug therapies where as only a 6% reduction has been reported in case of dietary therapies.

Evidently, periodic testing helps in timely detection of diseases & helps us to take appropriate measures to nab the bud in the root. So, even if you believe that you don’t have any disease, keep yourself monitored, for just in case…

Fda Approving Drugs

Drugstestproduct — Tue, 09 Nov 2010 12:11:52 +0000

The approval procedure of the Food and Drug Administration (FDA) for its regulated products is different from its own products. The obligatory FDA laws and the virtual dangers that these products can cause to ultimate consumers call for these discrepancies. FDA aims to provide safe and effective products to end users.

From product evaluation to label inspection, FDA tests every aspect of drugs and foods to ensure that they are safe and effective to people to consume.

When a person decides to have any drug or food, it is highly recommended to buy only FDA approving drugs or foods, since with these they can assure that the illusory ingredients labeled on the product cover do not deceives them. In fact, the FDA approval process ensures that its tested products are of high quality ingredients be it cosmetics, food items or drugs.

Thus, FDA plays a vital role in drug development. FDA had even devised certain rules and regulations for the drug development industry to produce only those products or drugs that will benefit the consumers. At present, there is not even a single drug approved by FDA, which people may refer as ineffective and unsafe, since it emphasizes more on safe drug development process and consumer health rather than profit making.

FDA Approved Drug Delivery System:

Transdermal drug delivery is one of the approved drug delivery systems of FDA. It is a non-invasive drug, which is injected from the exterior of the skin to the circulatory system. Originally, it was a skin patch approved in the year 1979 for treating motion sickness. FDA has approved transdermal drug delivery system only, because of its many significant benefits over traditional drug deliver methods such as:

Convenience of controlling addiction over drugs which may otherwise need frequent dosing

Enhanced bioavailability

More consistent plasma levels

No side-effects because of consistent plasma levels

Convenience of stopping the drug treatment by taking out the patch from the skin

Enhanced patient comfort, as it is painless, simple and non-invasive

Longer period of activeness leading to a reduction in the dosing frequency

Duragesic Product Liability – Personal Injury – Lawsuits

Drugstestproduct — Thu, 21 Oct 2010 09:15:37 +0000

Personal Injury Law Firms experienced in negligence, malpractice and other types of personal injury actions have taken note of recent product liability actions involving the drug, Duragesic.

Duragesic® is the trade name for a pain-medication patch containing fentanyl, a potent opioid analgesic. Duragesic is a transdermal system-the medicine, fentanyl, is absorbed through the patient’s skin and into the bloodstream, providing pain relief for up to three days (72 hours) from a single patch application.

Duragesic is prescribed in five dosage strengths: 12, 25, 50, 75 and 100 mcg of fentanyl per hour. The 50, 75, and 100 ug/h doses are only prescribed for patients who are already on and tolerant to opioid therapy, and require continuous opioid administration. Moreover, the Duragesic label warns that 12 mcg/hour as an initiating dose has not been systematically evaluated; therefore, Duragesic should be used only in patients who are opioid-tolerant.

Fentanyl was found to be a good choice for transdermal application because of its physicochemical properties and high analgesic potency. However, Fentanyl is not without its serious adverse effects. Pharmacologically, fentanyl acts on the central nervous system causing analgesia, sedation, severe respiratory depression, muscle rigidity, seizures, coma, and hypotension. Adverse reactions include mood changes, euphoria, dysphoria, drowsiness, constricted pupils, nausea, and vomiting. The most serious side effect of fentanyl overdose is hypoventilation (respiratory depression), which can be fatal.

Development of Duragesic

Currently, only eleven transdermally administered drugs are on the market; seven of which were developed by ALZA. In 1981, ALZA responded to a plea from a White House-created committee of scientists and physicians to develop more potent analgesics with alternative delivery systems for critically ill and dying patients who were suffering from intractable pain. ALZA began work on a project to develop a fentanyl transdermal patch in late 1982.

In early 1983, ALZA representatives met with agents from the DEA to discuss the handling of fentanyl. Among other issues, the DEA expressed concern that the dosage be kept to an absolute minimum, because of the potential for overdose and abuse.

In 1991, ten years after ALZA proposed the development of a transdermal fentanyl patch, Duragesic was made available for sale in the United States. Originally, Duragesic was approved to treat acute, postoperative and moderate-to-severe pain. However, due to the slow onset of drug levels from the transdermal delivery and three day maintenance of drug levels with Duragesic, the system was more suited for treatment of chronic pain conditions, in particular, cancer patients. By 1998, the World Health Organization (WHO) recommended transdermal fentanyl for treatment of cancer pain in stable patients.

Since receiving FDA approval in 1990, ALZA and Janssen aggressively sought the expansion of Duragesic use beyond cancer patients. For example, transdermal fentanyl has been used to treat rheumatologic pain and severe back pain.

The FDA has also approved an expansion of Duragesic to treat pediatric patients.

Janssen’s most recent advertising campaign to expand the use of Duragesic was thwarted by the FDA. In the late 1990s, the company sent a document called Top Ten List to doctors urging physicians to switch their patients to Duragesic patches rather than use more traditional type pain relievers. Among the reasons listed is the phrase “It’s not just for end stage cancer any more!” However, in 2000, the Department of Health and Human Services wrote a letter to Janssen informing the company that its promotional pieces concerning the “Broadening of indication” for Duragesic were misleading and contained misrepresentations. The government agency responded, “The suggestion that Duragesic can be used for any type of pain management promotes Duragesic for a much broader use that is recommended by the PI, and thus, is misleading.”

Currently, Duragesic is the most widely prescribed transdermal medication. From 2002 to 2003, the total number of fentanyl patch prescriptions within the United States rose from 4.5 million to 5.4 million-a twenty percent increase. And the resulting sales figures for Duragesic have been enormous: total annual sales in the United States have reached one and a half billion ($1,500,000,000.00) dollars annually.

And in 2005, Duragesic sales generated two point one billion ($2,100,000,000.00) dollars worldwide.

Duragesic Defects:

Package Leak-Subsequent Recalls

The design/manufacturing defect most applicable to our case is an improper sealing of one edge of the Duragesic patch, resulting in millions of patches being recalled. During 2004, ALZA (through Janssen) initiated two large Class I recalls of Duragesic for this exact reason. The first was February 17, 2004 at which time Duragesic Control No. 0327192 (75 mcg/hr) was pulled from the market. The cited reason was a potential seal breach on one edge of the patch, which could result in fentanyl leaking from the patch. This recall included about 440,000 patches.

On April 5, 2004, Janssen expanded its recall of Duragesic to include 2.2 million patches (Control Numbers 0327192, 0327193, 0327294, 0327295, and 0330362). Again, the reason cited was the potential for a breach of the seal, which would result in fentanyl leakage. Janssen sent a “Dear Healthcare Professional” letter to inform of the expanded recall.

A leak of fentanyl from a Duragesic patch could cause patients to receive either too much or too little of the drug.   If the fentanyl seeps out of the patch before its application to the skin, patients may receive too little medication to adequately treat their pain. In this situation, patients used to a specific does may experience withdrawal effects including sweating, sleeplessness, and abdominal discomfort.

Conversely, fentanyl leaks that occur while the patch is on the skin expose patients to a potentially life-threatening overdose of fentanyl. Duragesic is designed to deliver only a controlled amount of fentanyl into the patient’s skin. Patients wearing a defective patch that leaks fentanyl directly onto the skin will receive too much of the medication. If this occurs, patients could experience minor complications such as sedation, drowsiness, and nausea. Fentanyl overdose may result in more serious complications, including fatal hypoventilation (respiratory depression) or cardiac arrest.

When Jansen placed Duragesic on the market in 1991, reports of toxicity due to fentanyl overdosing were fairly common. In fact, one study in California of 112 deaths associated with fentanyl concluded that the general availability of the drug may be responsible for the high incidence of overdoses.

Furthermore, in a recent Duragesic lawsuit filed against Johnson & Johnson, Janssen, and ALZA, the plaintiffs alleged that “despite knowing of this defect, the defendants (Johnson & Johnson, Janssen, ALZA) took inadequate steps to advise physicians, hospitals, nursing homes and other health care professionals of the defect and the significant damages to users of the Duragesic patches.”

Heat-Induced Overdose

ALZA and Janssen’s knowledge of the overdosing potential caused by external heat dates back to 1986, when ALZA did lab testing on a nitroglycerin-delivering patch using the same co-polymer membrane used in Duragesic patches.   ALZA subsequently did lab testing on Duragesic in 1988-that showed that a five degree Centigrade increase in temperature doubled Duragesic’s release rate. Dr. Curtis Wright, the FDA Medical Review Officer, was quite concerned in 1989 and again in 1990 that ALZA had not responded to his request for more information on the effects of external heat. After Duragesic hit the market in April of 1991, ALZA and Janssen learned of six reports from healthcare providers that external heat appeared to increase blood fentanyl levels in patients in the hospital setting and at home.

However, the first time Janssen or ALZA made an effort to warn of the effects of external heat came in a January 17, 1994 “Dear Doctor” letter with an attached proposed labeling revision. The labeling contained a new heat warning, which was buried at page 10 of the attachment, but no mention was made in the letter itself to alert physicians that external heat applied to the patch was potentially life-threatening.

GOVERNMENT REGULATION

In 2004, the FDA influenced Janssen and ALZA to issue two Class I Recalls of Duragesic, “due to improper sealing of one of their edges,” which could result in a life-threatening overdose of fentanyl. Yet, this was not the first time the FDA encountered problems with the companies’ handling of Duragesic. In fact, prior to the recalls in 2004, the FDA has required Duragesic labeling revisions 13 times.

And, as recently as July 2005, the FDA issued a Public Health Advisory concerning the use of Duragesic Patches in response to reports of deaths in patients using the patch.

Beginning in 1994, the FDA sent ALZA a “warning letter” identifying certain violations and deviations from Good Manufacturing Practices (GMP) regulations under the Food and Drug Act. This prompted the company to issue a letter to all health care professionals warning of Duragesic misuse.

In the late 1990s, the Department of Health and Human Services warned Janssen that its promotional materials to expand the use of Duragesic were in direct violation of the Federal Food, Drug, and Cosmetic Act and contained misrepresentations as to the safety and efficacy of the product. The agency determined that the promotional pieces were “false or misleading because they contain misrepresentations of safety information, broaden Duragesic’s indication, contain unsubstantiated claims, and lack fair balance.”

Following Janssen’s “voluntary” recall of Duragesic in 2004, the FDA issued a “Safety Alert” warning that the recall was “due to a potential leak in the product seal,” which could result in skin exposure to fentanyl. The warning adds that “skin exposure to any leaked medication from a DURAGESIC patch may cause nausea, sedation, drowsiness, or potentially life-threatening complications.” Govt Regulation 6. Janssen also wrote a letter to “Healthcare Professional[s]” informing them of the expanded recall in April 2004.

Furthermore, on September 2, 2004 the FDA issued Janssen another “warning letter.” This letter states that the latest Duragesic promotional pieces make “false or misleading claims about the abuse potential and other risks of the drug, including unsubstantiated effectiveness claims for Duragesic.” The letter states, “By suggesting that Duragesic has a lower potential for abuse compared to other opioid products, the file card could encourage the unsafe use of the drug, potentially resulting in serious or life-threatening hypoventilation.”

The Duragesic product label was again updated in June 2005 to add new safety information in several areas of labeling, and Janssen issued another “Dear Healthcare Professional” letter about these changes. Under a section entitled “Hypoventilation (Respiratory Depression),” the letter warns that “Serious or life-threatening hypoventilation may occur at any time during the use of DURAGESIC® especially during the initial 24-72 hours following initiation of therapy and following increases in dose.” Janssen also warns of a “potential for temperature-dependant increases in fentanyl released from the system resulting in possible overdose and death.” Therefore, the letter instructs all patients to avoid exposing Duragesic to “direct external heat sources, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, and heated water beds, etc., while wearing the system.”

Finally, on July 15, 2005 the FDA issued a “Public Health Advisory” concerning the use of Duragesic Patches in response to reports of deaths in patients using the patch. The FDA stated it is conducting an investigation into the deaths related to fentanyl overdose in patients using Duragesic. According to the FDA, “Some patients and health care providers may not be fully aware of the dangers of this very strong narcotic painkiller. Therefore, FDA is issuing this public health advisory to alert patients and their caregivers and health care professionals by highlighting the following important safety information.”

MEDICAL LITERATURE

Fentanyl Overdose

Since Duragesic hit the marketplace in 1991, studies have shown continued high numbers of overdoses involving transdermal delivery of fentanyl. The most serious side effect is respiratory depression, which can be fatal. One study, published in 1991, examined 112 fentanyl-related deaths in the Eastern United States, mostly in California. Fentanyl deaths appeared to occur rapidly, “probably the result of acute respiratory depression.” While acknowledging the extreme potency of fentanyl, the author suggests that “the incidence of fentanyl-related deaths is probably determined by the general availability of the drug, rather than the relative potency of the analogs.”

In a study published in 2000, the Los Angeles County Department of the Coroner analyzed 25 cases involving fentanyl-related deaths.    The author notes that the Los Angeles County Coroner’s Office evaluates nearly one case each month involving fentanyl patch-related death. Another study that same year identified 61 cases of transdermal drug overdoses in a Regional Poison Information System over a five-year period.

Head-Induced Overdose

Heat is expected to increase skin permeability, metabolism and elimination of fentanyl. If drug release from the system is much faster than permeation through the skin, the skin controls the transdermal absorption rate into the patient’s systemic circulation, rather than Duragesic’s special rate control membrane.

Several case reports have described the development of life-threatening overdose caused by a heating pad or rise in body temperature. Frolich et al. reported a narcotic overdose in a patient that was using a warming blanket to relieve pain following surgery. Medical Literature 17, see M.A. Frolich et al., Opioid Overdose in a Patient Using a Fentanyl Patch During Treatment with a Warming Blanket, 93 ANESTH. ANALG. 647-48 (2001) (unable to obtain hard copy). The increase in absorption may account for other heat-related toxicity associated with transdermal fentanyl. G. Newshan, Heat-Related Toxicity with the Fentanyl Transdermal Patch, 16 J. PAIN SYMPTOM MGMT. 277-78 (1998) (unable to obtain hard copy).

One study, in 2003, examined the effect of heat on transdermal fentanyl absorption. The authors concluded that increases in skin temperature may result in increased systemic absorption of fentanyl. Therefore, warming blankets and heating pads should not be either used in conjunction with, or placed over Duragesic patches.

However, as of 2003, the Duragesic label warned that serum fentanyl concentrations may “theoretically” increase by one third in patients with a body temperature of 40 degrees Celsius because of accelerated drug release and increased skin permeability. The current label warns of a “potential for temperature-dependent increases in fentanyl release from the system.”