The FDA watches risk factors of different drugs and occasionally they will either put out a warning or in some cases pull a product all together. Well today one product type for pain relief did get pulled

On July 7, 2009, the Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.

FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug’s potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment. Read the rest of this entry »

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Tags: Darvon, dizziness, fda, food and drug administration, lightheadedness, nausea, pain, vomiting

If you’ve ever been treated for severe pain from surgery, an injury, or an illness, you know just how vital pain relief medications can be.

Pain relief treatments come in many forms and potencies, are available by prescription or over-the-counter (OTC), and treat all sorts of physical pain— including that brought on by chronic conditions, sudden trauma, and cancer.

Pain relief medicines (also known as “analgesics” and “painkillers”) are regulated by the Food and Drug Administration (FDA). Some analgesics, including opioid analgesics, act on the body’s peripheral and central nervous systems to block or decrease sensitivity to pain. Others act by inhibiting the formation of certain chemicals in the body.

Among the factors health care professionals consider in recommending or prescribing them are the cause and severity of the pain.

TYPES OF PAIN RELIEVERS

OTC Medications
These relieve the minor aches and pains associated with conditions such as headaches, fever, colds, flu, arthritis, toothaches, and menstrual cramps.

There are basically two types of OTC pain relievers: acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs).

Acetaminophen is an active ingredient found in more than 600 OTC and prescription medicines, including pain relievers, cough suppressants, and cold medications.

NSAIDs are common medications used to relieve fever and minor aches and pains. They include aspirin, naproxen, and ibuprofen, as well as many medicines taken for colds, sinus pressure, and allergies. They act by inhibiting an enzyme that helps make a specific chemical.

Prescription Medications
Typical prescription pain relief medicines include opioids and non-opioid medications.

Derived from opium, opioid drugs are very powerful products. They act by attaching to a specific “receptor” in the brain, spinal cord, and gastrointestinal tract. Opioids can change the way a person experiences pain.

Types of prescription opioid medications include

• morphine, which is often used before and after surgical procedures to alleviate severe pain
• oxycodone, which is also often prescribed for moderate to severe pain
• codeine, which comes in combination with acetaminophen or other non-opioid pain relief medications and is often prescribed for mild to moderate pain
• hydrocodone, which comes in combination with acetaminophen or other non-opioid pain relief medications and is prescribed for moderate to moderately severe pain

FDA has recently notified makers of certain opioid drugs that these products will need to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits continue to outweigh the risks.

Affected opioid drugs, which include brand name and generic products, are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.

FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007.

Types of non-opioid prescription medications include ibuprofen and diclofenac, which treat mild to moderate pain.

USE PAIN RELIEVERS AS DIRECTED

Pain medications are safe and effective when used as directed. However, misuse of these products can be extremely harmful and even deadly.

Consumers who take pain relief medications must follow their health care professional’s instructions carefully. If a measuring tool is provided with your medicine, use it as directed.

Do not change the dose of your pain relief medication without talking to your doctor first.

Also, pain medications should never be shared with anyone else. Only your health care professional can decide if a prescription pain medication is safe for someone.

Here are other key points to remember.

With acetaminophen:

• Taking a higher dose than recommended will not provide more relief and can be dangerous.
• Too much can lead to liver damage and death. Risk for liver damage may be increased in people who drink three or more alcoholic beverages a day while using acetaminophen-containing medicines.
• Be cautious when giving acetaminophen to children. Infant drop medications can be significantly stronger than regular children’s medications. Read and follow the directions on the label every time you use a medicine. Be sure that your infant is getting the infants’ pain formula and your older child is getting the children’s pain formula.

With NSAIDs:

• Too much can cause stomach bleeding. This risk increases in people who are over 60 years of age, are taking prescription blood thinners, are taking steroids, have a history of stomach bleeding or ulcers, and/or have other bleeding problems.
• Use of NSAIDs can also cause reversible kidney damage. This risk may increase in people who are over 60 years of age, are taking a diuretic (a drug that increases the excretion of urine), have high blood pressure, heart disease, or pre-existing kidney disease.

With opioids:

• Use of opioids can lead to drowsiness. Do not drive or use any machinery that may injure you, especially when you first start the medication.
• The dose of an opioid pain medication that is safe for you could be high enough to cause an overdose and death in someone else, especially children.

KNOW THE ACTIVE INGREDIENTS

A specific area of concern with OTC pain medicines is when products sold for different uses have the same active ingredient. A cold and cough remedy may have the same active ingredient as a headache remedy or a prescription pain reliever.

To minimize the risks of an accidental overdose, consumers should avoid taking multiple medications with the same active ingredient at the same time.

All OTC medicines must have all of their active ingredients listed on the package. For prescription drugs, the active ingredients are listed on the container label.

Talk with your pharmacist or another health care professional if you have questions about using OTC medicines, and especially before using them in combination with dietary supplements or other OTC or prescription medicines.

MISUSE AND ABUSE
Misuse and abuse of pain medications can be extremely dangerous. This is especially so in regard to opioids. These medications should be stored in a place where they cannot be stolen.

According to the National Institutes of Health, studies have shown that properly managed medical use of opioid analgesic compounds (taken exactly as prescribed) is safe, can manage pain effectively, and rarely causes addiction.

But the abuse of opioids is a significant public safety concern. Abusers ingest these drugs orally, and also crush the pills in order to snort or inject them.

Commonly abused opioid pain medicines include prescription drugs such as codeine, and the brand-name products Oxycontin (oxycodone), Vicodin (hydrocodone with acetaminophen), and Demerol (meperidine).

Addiction is just one serious danger of opioid abuse. A number of overdose deaths have resulted from snorting and injecting opioids, particularly the drug OxyContin, which was designed to be a slow-release formulation.

USE OPIOIDS SAFELY:  3 KEY STEPS

1. Keep your doctor informed. Inform your health care professional about any past history of substance abuse. All patients treated with opioids for pain require careful monitoring by their health care professional for signs of abuse and addiction, and to determine when these analgesics are no longer needed.
2. Follow directions carefully. Opioids are associated with significant side effects, including drowsiness, constipation, and depressed breathing depending on the amount taken. Taking too much could cause severe respiratory depression or death. Do not crush or break pills. This can alter the rate at which the medication is absorbed and lead to overdose and death.
3. Reduce the risk of drug interactions. Don’t mix opioids with alcohol, antihistamines, barbiturates, or benzodiazepines. All of these substances slow breathing and their combined effects could lead to life-threatening respiratory depression.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

Tags: acetaminophen, aches, allergies, arthritis, brand-name products, cancer, chemical, chemicals, constipation, cough, cramps, dietary supplements, drowsiness, fever, food and drug administration, generic products, headache, headaches, heart disease, high blood pressure, ibuprofen, kidney disease, machinery, OTC, OxyContin, pain, pains, peripheral and central nervous systems, pharmacist, respiratory depression, surgery, toothaches, www.fda.gov/consumer, www.fda.gov/consumer/consumerenews.html

Stevia has been used in sodas marketed as dietary supplements and in other countries for sweetening treats and other foods but before now was not officially approved by the Food and Drug Administration (FDA). Experts had predicted the FDA would approve before the end of the year and the market for natural-based sweeteners would rise exponentially. December is as close to the New Year as can be and seems like the perfect time for introducing new products.

Officially recognized by the FDA this week, Cargill received the notification in the form of a letter stating that they have no objection to the previously submitted research that rebaudioside A (rebiana)—Truvia’s scientific name—has been generally recognized as safe (GRAS). The letter continues to support Truvia’s safety and the research behind a panel of experts from an independent company that provided the data.

PepsiCo has also teamed up with Merisant to produce PureVia another stevia-based sweetener, which also received the same FDA safety letter this week.

Cargill has complete confidence in this product and is elated at the recent findings that stevia-based sweeteners are now safe for use by all consumers. Marcelo Montero, president of Cargill, stated, “The FDA brought the appropriate rigor to the process and we are extremely pleased with the news.” Read the rest of this entry »

Tags: Cargill, Coca-Cola, dietary supplements, food and drug administration, Marcelo Montero, new years day, PepsiCo, president, stevia products, stevia-made products

The FDA is advising people to be more aware of food labels and has written and extensive article on what to look at and why. I also wrote and article on how to decipher the important parts of understanding food labels last year.

Consumers often compare prices of food items in the grocery store to choose the best value for their money. But comparing items using the food label can help them choose the best value for their health.

The food label identifies a variety of information about a product, such as the ingredients, net weight, and nutrition facts.

“The food label is one of the most valuable tools consumers have,” says Barbara Schneeman, Ph.D., Director of the Food and Drug Administration’s (FDA’s) Office of Nutrition, Labeling and Dietary Supplements. “The food label gives consumers the power to compare foods quickly and easily so they can judge for themselves which products best fit their dietary needs.”

For example, someone with high blood pressure who needs to watch salt (sodium) intake may be faced with five different types of tomato soup on the shelf, says Schneeman. You can quickly and easily compare the sodium content of each product by looking at the part of the label that lists nutrition information (Nutrition Facts Label) to choose the one with the lowest sodium content.

Read the rest on the FDA site on Food Labeling

Tags: Barbara Schneeman, consumers, director, fda, food, food and drug administration, food items, food label, food labels, high blood pressure, Labeling and Dietary Supplements, nutrition facts, nutrition information, nutrition labeling, Office of Nutrition, sodium content

The U.S. Food and Drug Administration today notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.

In an early communication based on the FDA’s ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.

The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults. Read the rest of this entry »

Tags: botox, Botox Cosmetic, botulism, cerebral palsy, fda, food and drug administration, respiratory failure, safety reviews, symptoms of botulism, U.S. Food and Drug Administration

Melamine was the biggest problem in the dog food recall a couple of weeks ago that was a result of dangerous dog food killing animals throughout north america. After that food scare some people started looking at the human food sources that may have melamine in them.

Today the FDA came out with a press release that stated that food for people does not seem to be dangerous. Here are a couple of quotes from that press release.

There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds, according to an assessment conducted by scientists from five federal agencies.

In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe. In other words, it was well below any level of public health concern.

The risk assessment is an important new science-based component of the continuing federal joint investigation into imported wheat gluten and rice protein concentrate from China that contained melamine and melamine-related compounds.

The risk assessment was conducted by scientists from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS), the Environmental Protection Agency (EPA), U.S. Customs and Border Protection (CBP) of the Department of Homeland Security (DHS) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). This team is now compiling a scientific assessment of the risk to animal health associated with ingestion of animal feed containing melamine and its compounds.

Hopefully now we will not have to worry about melamine and can concentrate on all of the other issues from pesticides to salmonella in our food.

Tags: Centers for Disease Control and Prevention, China, couple, dangerous dog food killing animals, Department of Health and Human Services, Department of Homeland Security, dog food, Environmental Protection Agency, fda, feed, food, food and drug administration, food health, Food Safety and Inspection Service, food scare, human food sources, pet food scraps, potential exposure, U.S. Department of Agriculture

One of the issues that always comes up with prescriptions is the idea of brand name drugs versus the use of generic drugs. Drug companies are very good at researching and creating drugs and for this they get a patent on these drugs so that they can sell them with no competition for a period of a few years and this is a fantastic advantage for them. All you

After a period of 7 to 17 years depending on the drug there is a time when companies can create and market copycat drugs, generic drugs, that can compete with the Major drug companies original drug. There is a very large market on both sides of this issue and as you can imagine the marketing and government lobbying in this field are extremely aggressive.

need to see how powerful a restricted market is is to look at the impact on society and marketing that Pfizer has had with their little blue pill Viagra. When Viagra hit the market and for many years there is not competition and Pfizer has really made the most of the Viagra name to build that market so that any competition by a generic drug when they are allowed will be an uphill battle. The Federal Trade Commission has some into on generic drugs that I thought I would share.

Prescription drugs can be a costly medical expense, especially for older people and those who are chronically ill. However, each state has a law that lets pharmacists substitute less expensive generic drugs for many brand-name products. Depending on your prescription needs, your savings could be significant. Before you talk with your doctor or pharmacist about switching, there are things you need to know about generic drugs and the law.
Read the rest of this entry »

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The promise of a more youthful look was too tempting for 53-year-old Mary Schwallenberg to pass up. So, when the Food and Drug Administration approved a product that temporarily improves the appearance of frown lines between the eyebrows, the Orlando, Fla., resident took a shot at it. And it wasn’t long before she became one of many people clamoring for regular treatments that often include refreshments and friendly conversation, as well as injections.

Botulinum Toxin Type A (Botox Cosmetic) is a protein complex produced by the bacterium Clostridium botulinum, which contains the same toxin that causes food poisoning. When used in a medical setting as an injectable form of sterile, purified botulinum toxin, small doses block the release of a chemical called acetylcholine by nerve cells that signal muscle contraction. By selectively interfering with the underlying muscles’ ability to contract, existing frown lines are smoothed out and, in most cases, are nearly invisible in a week.

Botox injections are the fastest-growing cosmetic procedure in the industry, according to the American Society for Aesthetic Plastic Surgery (ASAPS). In 2001, more than 1.6 million people received injections, an increase of 46 percent over the previous year. More popular than breast enhancement surgery and a potential blockbuster, Botox is regarded by some as the ultimate fountain of youth.

Schwallenberg, a pharmaceutical sales representative who is excited about her next round of injections, says she wants to look her best for her job. “That’s corporate America for you,” she says. “I have a lot of energy and I just wanted to look good.”

Botox was first approved in 1989 to treat two eye muscle disorders–uncontrollable blinking (blepharospasm) and misaligned eyes (strabismus). In 2000, the toxin was approved to treat a neurological movement disorder that causes severe neck and shoulder contractions, known as cervical dystonia. As an unusual side effect of the eye disorder treatment, doctors observed that Botox softened the vertical frown (glabellar) lines between the eyebrows that tend to make people look tired, angry or displeased. But until this improvement was actually demonstrated in clinical studies, Allergan Inc., of Irvine, Calif., was prohibited from making this claim for the product.
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Tags: Allergan Inc., America, American Society for Aesthetic Plastic Surgery, American Society for Dermatologic Surgery Botox, April, blepharospasm, board-certified plastic surgeon, botox, Botox Cosmetic, botulism, California, cervical dystonia, chemical called acetylcholine, dermatologic medical officer, Ella L. Toombs, energy, eye disorder, FDA's Division of Vaccines and Related Products Applications, FDA's Office of Cosmetics and Colors, Florida, flu syndrome, food and drug administration, headache, injection site, Irvine, Julianne Clifford, Mary Schwallenberg, movement disorder, muscle contraction, muscle disorders, muscle weakness, nausea, Orlando, pain, pharmaceutical sales representative, plastic surgery, poisoning, prescription product, president, qualified physician, respiratory infection, retail venues, scars, Scott A. Greenberg, skin surgery, strabismus, surgery, the eye disorder treatment, United States, vaccines, Winter Park

Sertraline is used medically mainly to treat the symptoms of depression and anxiety. It has also been prescribed for the treatment of obsessive-compulsive disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, panic disorder, and bipolar disorder. It was first approved by the FDA in 1991. The patent for this brand-name drug expired in December 2005. It is anticipated that the generic drug will be available in the United States in June of 2006, manufactured by Andrx, Aurobindo, Genpharm, Ivax, Mylan, and Roxane. In Scandinavia a generic drug called Sertralin, manufactured by HEXAL is available. The price differences between Zoloft and Sertralin are as high as 1.50 dollars per pill.

Sertraline can have a number of adverse effects, including insomnia, asthenia, gastrointestinal complaints, tremors, confusion, dizziness, anorgasmia, and decreased libido; it can induce mania or hypomania in around 0.5% of patients. It has also been known to cause minor weight loss. It is contraindicated in individuals taking MAOIs or undergoing electroconvulsive therapy.

Until 2003 Zoloft was only approved for use in adults ages 18 and over; that year it was approved by the FDA for use in treating children ages 6 to 17 with extreme obsessive compulsive disorder. In June, 2004, Britain banned the use of Zoloft by minors and in February, 2005, Pfizer was forced to change the labeling of Zoloft to include information regarding increased incidences of suicidal behavior and depression in adolescent users of the drug. According to mentalhealth.com, Zoloft is not currently recommended or advised for use in individuals under the age of 18. After these changes, multiple incidences and at least one medical study showed an increased risk of suicide in seniors who were taking Zoloft. In response to these findings, the FDA released a public health warning. This warning indicates that anyone currently using Zoloft for any reason has a greater chance of exhibiting suicidal thoughts or behaviors regardless of age. This warning is questionable, however, due to the types of illnesses Zoloft is used to treat, it is impossible to determine if these tendencies are a side effect of the drug or the illness the drug is meant to treat.
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All of us contact lens wearers know that it is a good idea to take good care of your lenses or your eyes will suffer. This includes cleaning contact lenses and not wearing your contact lenses for more than eight to ten hours. Here are some tips from the FDA.

The FDA and CDC are urgently advising consumers to take precautions to prevent contamination of the lenses and the products used to maintain them. These preventive practices include:

* Wash hands with soap and water, and dry (lint-free method) before handling lenses.
* Wear and replace lenses according to the schedule prescribed by the doctor.
* Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
* Keep the contact lens case clean and replace every 3-6 months.
* Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

In addition, regardless of which cleaning/disinfecting solution used, wearers may want to consider performing a “rub and rinse” lens cleaning method, rather than a no-rub method, in order to minimize the number of germs and reduce the chances of infection.

Bausch & Lomb has recommended that consumers stop using ReNu with MoistureLoc immediately and discard all remaining MoistureLoc solution including partially used or opened bottles. Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of fungal keratitis in an effort to determine all contributing factors and/or products that may place contact lens wearers at increased risk for Fusarium keratitis. As part of this ongoing investigation, we are continuing joint inspections of the Bausch & Lomb plant and facilities in Greenville, SC including testing of products, environmental factors and raw materials. Because of the nature of the organism (Fusarium), extensive microbiological testing is being conducted and may take up to one month to fully analyze. We are committed to continuing a comprehensive approach aimed at determining the cause of these infections and will provide regular updates on our activities through preliminary public health notices issued through FDA.

As reported in the MMWR, patients with confirmed cases of Fusarium keratitis have reported using various contact lens cleaning solutions including various types of ReNu products and generics. We continue to confirm reported cases associated with products other than ReNu with MoistureLoc. Our interest in the MoistureLoc product is based on the disproportionate number of case of Fusarium keratitis associated with ReNu with Moisture Loc compared to the overall product market share. The trends of reported cases involving various contact lens solutions other than MoistureLoc have remained consistent throughout our investigation.

FDA continues to work with the CDC to investigate the Fusarium keratitis infections and will determine whether or not further action needs to be taken. While the investigation is ongoing, FDA will continue to update the public health notice and advice to consumers as needed. In addition, the FDA and CDC are urgently advising consumers to consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling. In addition, the Centers for Disease Control and Prevention (CDC) released further clarification on the information on the multi-state outbreak of Fusarium keratitis that may be associated with contact lens use.

Tags: Bausch & Lomb, Centers for Disease Control and Prevention, contact lens cleaning solutions, contact lens solutions, fda, food and drug administration, Greenville, keratitis, light sensitivity, pain, ReNu, solution manufacturer, South Carolina