The FDA has just approved the first generic version of Lovenox, a popular blood thinner. The drug’s entry into the market could mean hundreds of dollars in savings for someone who depends on the drug for stroke/heart disease treatment.

Lovenox is used to treat and prevent deep vein thrombosis, a condition that, if left unchecked, can cause stroke or pulmonary embolism (blood clots in the lung).

Momenta, the company whose technology was used to produce the new generic (M-Enoxaparin), has been awaiting approval for five years. They’ve spent the last half-decade battling Sanofi-Aventis, makers of Lovenox, over the drug’s efficacy.

According to Sanofi-Aventis, the biologically derived drug is complex and difficult to reproduce, and that it could fail with even the slightest error. They argue that the new generic may not be safe for consumers. The U.S. District Court in Washington, D.C. is considering the company’s case, but for now Sandoz/Momenta’s M-Enoxaparin is legal and available for use.

“The approval of M-Enoxaparin marks a key milestone for Momenta, and we are extremely pleased,” said Momenta president and CEO Craig Wheeler in a press release. “This is the first product based on Momenta’s technology platform to be approved, and demonstrates our ability to characterize and develop a complex mixture drug like Lovenox.”

Read the original article in the New York Times, or read Momenta’s press release for more details.

Proper medication disposal can keep you and those around you safe. That's why it's important to keep track of expired medicines and to dispose of them properly.

Proper drug disposal can help protect against reactions from expired medications, accidental ingestion (i.e., by children), and potential prescription drug abuse by others. It can also protect the environment by ensuring cleaner water sources. We've compiled a list of tips to help you practice drug safety:

• Color-code drug packages/bottles with different-colored stickers according to expiration date (i.e., by season or month). Writing a larger, more visible expiration date on the package with a permanent marker may also help.
• Don’t flush expired drugs down the toilet. The U.S. Food and Drug Administration has specific guidelines on what can and cannot be flushed. Flushing drugs can cause pollution to human water supplies and danger to natural aquatic habitats.
• The Office of National Drug Control Policy suggests crushing pills, if possible, and mixing them with sand, coffee grounds, gravel, etc., before returning them to the bottle and throwing away. This ensures that no one will try to use the substance. Always make sure labels with personal information have been removed. Then, simply throw the container in the trash.
• Some communities have drug take-back programs. These programs are organized specifically to safely dispose of prescription drugs and other potentially dangerous household wastes. Talk with your pharmacist about other options to properly dispose of over-the-counter and prescription medications if your community does not offer a drug return program.           

For more on proper medication disposal, visit the FDA’s site for the Department of Health&Human Services.

Controversy is brewing over K2, a "drug" similar to pot. Prior to its ban last week in Kansas and another county in Missouri, the drug was completely legal in all 50 states. Now there is debate over the dangers involved with its use.

K2—sometimes called “genie” or “Zohai”—is a substance chemically similar to pot. Its key ingredient, JWH-018, is a synthetic cannabinoid that mimics marijuana’s euphoria-causing agent THC.

Clemson University chemist John W. Huffman developed the chemical in 1995 for purely experimental purposes, but its legitimacy and availability made it a popular alternative to marijuana.

The chemical is sprayed on herbs and sold as an incense called “spice”, but is more often smoked to get high—JWH can be up to five times more potent than marijuana.

Little is known about the actual effects of the drug, but some users have reported hallucinations, vomiting and high blood pressure. Others say it’s one of the best highs they’ve ever experienced. The drug is unregulated, which may explain why some users have experienced adverse effects. You can never be sure of what you’ll get.

Legislators and concerned parents continue to squabble about its legitimacy, but for now it’s still legal in most states. Huffman told The Observer he’s just surprised it didn’t catch on sooner.

"I've come to the conclusion,” he says, “that if an enterprising person wants to find a new way to get high, they're going to do it."

The bottom line is that more investigation is needed to determine the effects of the drug’s use. Read the original article on K2 in Newsweek, or see Huffman’s interview in The Observer.

Worries over job security and the stigma attached to mental illness may be keeping workers from seeking professional help for mental and emotional disorders.

An online survey conducted by the American Psychiatric Association reported three out of five workers expressed concern that mental health counseling would threaten professional status. More than 2,000 adults participated in the study; 1,129 were employed full- or part-time.

Although 40 percent of respondents said their employers were supportive of employee health treatment, others said their employers were less supportive of health services, more so for those concerning mental health.

Participants affected by drug addiction, alcoholism and depression were most concerned. People with diabetes and heart disease were shortly behind.

According to a report in Research Works, a publication of the Partnership for Workplace Mental Health (PWMH), there is a high prevalence of these conditions in the workplace.

“The majority (about two thirds) of people with symptoms of clinical criteria for having mental and substance use disorders do not receive any treatment at all for these conditions,” wrote report author Mark Attridge, PhD. In addition to job security and professional status, confidentiality was another concern for employees.

Researchers say that employee access to quality mental health and addiction services is needed. They suggest that the workplace promote promotion and intervention, and that employers make sure employees know how to access their benefits. They also encourage employers to be supportive and to reassure workers of confidentiality.

Dr. Alan Axelson, PWMH council chairman, stresses the importance of encouraging employees to take care of their mental and physical health, and explains that it can benefit employers as well.

“Research supports the fact that when people receive needed care, they are healthier and more productive,” he said in a press release, “Employers realize the return on their healthcare investment.”

When it comes to dosages of cold medicine, your kitchen spoons may not be measuring up. Using spoons to measure medicine may be causing you to under or overdose, according to new research in the Annals of Internal Medicine.

“Spoon dosing has been identified as 1 of the 3 major causes of dosing errors and pediatric poisonings,” authors of the study wrote. “Most persons still use spoons when pouring medicine for themselves and their families.”

Nearly 200 university students were asked to measure what they perceived to be equal amounts of cold medicine into three different spoons—a standard teaspoon, a medium-sized spoon, and a larger spoon.

“We first gave them a full bottle of cold medicine and a teaspoon and asked them to pour exactly 1 teaspoon (5 mL),” authors of the study explain. “Next, we asked participants to pour the same 5-mL dose into each of the remaining 2 spoons in a randomized order.”

Standard dosage for most cold medicines is usually between 2 teaspoons and 2 tablespoons. Although most participants were confident that they’d measured accurately, they measured 8.4 percent (.42 mL) too little when using the medium-sized spoon, and 11.6 percent (.58 mL) too much when using the large spoon.

Although that may not seem like much for per dose, a little change in medicine can make a lot of difference. According to study leader Dr. Brian Wansink of the Cornell Food and Brand Lab, this can add up to the point of ineffectiveness or even danger.

They also point out that this could reach farther than the kitchen at home. Even the most practiced nurse or Dr. Mom could be measuring incorrectly when using spoons because the size of the spoon makes the same amount appear differently.

“Simply put, we cannot always trust our ability to estimate amounts," co–author, Dr. Koert van Ittersum, Assistant Professor of Marketing at Georgia Tech, said in a press release. "In some cases it may not be important, but when it comes to the health of you or your child, it is vital to make an accurate measurement."

Certain types of antipsychotic medication can cause children to put on weight—as much as 18 pounds—according to research appearing in the Journal of the American Medical Association.

Dr. Chrostoph Correll, MD, and associates observed 272 children aged 4 to 19 taking atypical antipsychotic medication for the first time. Drugs/Medications included olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperadol) and aripiprazole (Abilify)—drugs sometimes used to treat children with autism, schizophrenia or bipolar disorder.

Children’s weights were monitored over a 12-week period. During the last two weeks of the study, nearly all experienced significant weight gain. Average gain was as follows: 18.7 pounds with onanzapine, 13.7 pounds with quetiapine, 11.7 pounds with risperidone, and 9.7 pounds with aripiprazole. Children in the control group gained less than half a pound (.44 pounds) on average.

“(E)ffects such as age-inappropriate weight gain, obesity, hypertension, and lipid and glucose abnormalities are particularly problematic during development because they predict adult obesity, metabolic syndrome, cardiovascular morbidity, and malignancy,” authors of the study write.

Doctors were so concerned over weight gain in children taking onanzapine that they stopped treatment before the study was completed. “Each antipsychotic was associated with significantly increased fat mass and waist circumference,” authors write. “Altogether, 10 percent to 36 percent of patients transitioned to overweight or obese status within 11 weeks.”

As more children—some younger than 5-years-old—are diagnosed with bipolar and “disruptive behavior” disorders (such as ADHD), there is also a rise in atypical antipsychotic prescriptions. These medications are generally effective for children with autism and schizophrenia, but they may not be the best treatment for other conditions.

The authors suggest seeking alternative treatments. They write that, in view of the negative health outcomes, the benefits of using these medications “must be balanced against their cardiometabolic risks”, and say the results suggest including in prescription guidelines closer monitoring during the early months of treatment.

They also plan on researching whether or not diet restrictions and additional medications for weight and glucose control will help balance the potential negative effects of the drugs.

More teens are calling for help with ADHD prescription drug abuse, according to information obtained from the American Association of Poison Control Center. Calls to the center from 13-19 year-old victims regarding prescription ADHD medication abuse rose 76% between 1998 and 2005.

These types of calls rose more quickly than those for general substance abuse by teens (up 55%). ADHD medication prescriptions were up 80% over the same time period, a figure researchers suspect is no coincidence. Girls called more frequently than boys, representing 40% of all victims, but boys suffered more severe effects than girls, who accounted for just over 19% of major effects or death.

Researchers can only speculate why the imbalance is so drastic: “We don’t know for sure whether the increased calls for help are the result of simply more abuse or the escalating severity of consequences,” explains G. Randall Bond, MD, director of the Poison and Information Center at Cincinnati Children’s Hospital.

“The findings suggest that more teens are abusing and misusing stimulant ADHD medications because they have access to those medications, not because a higher percentage of those treated have turned to abusing their medication,” explains lead author Jennifer Setlik, MD, also of Cincinnati Children’s Hospital.

Attention deficit hyperactive disorder (ADHD) is a common childhood disorder that can continue through adulthood. Individuals with ADHD may be extremely talkative or fidgety, and often have difficulties with impulsiveness, patience, following instructions, hyperactivity, attentiveness, and behavioral control.

Most of the medications used to treat ADHD are amphetamines, stimulants intended to boost concentration; drugs such as Adderall, Dexedrine, or Ritalin are typically prescribed. Teens abuse these stimulants to increase focus, to reduce pain and anxiety, or to get high without knowing the side effects.

Side effects may include insomnia or tiredness, cottonmouth, dizziness, and headaches. In more extreme cases, however, they may cause vomiting, seizure, or psychiatric problems, including hallucinations. Strattera, a non-stimulant antomoxetine, can cause users to have an increased likelihood of suicidal thoughts.

"Clearly," says Setlik, "we are seeing a rising problem with the abuse of these medications." As the drug abuse problem progresses, education continues to be stressed as a means of prevention.

Click here for more information on how to talk to your child about drug abuse.

Prescription drug sharing among teens is becoming a great concern in the United States, where 1 in 3 self-reportedly loan or borrow medication.
According to a survey funded by the National Center on Birth Defects and Developmental Disabilities (NCBDDD), 20.6% of teens reported loaning drugs, most commonly pain relievers and allergy medications, and 19.4% reported borrowing them. Girls were almost twice as likely to give away prescription medications than boys (27.5% of girls, compared to 17.4% for boys).

Information for the study was gathered in malls, parks and public streets, in eleven urban and suburban locations in the United States. Researchers obtained data from 594 teens—289 male and 305 female—ages 12-17.

“Prior to our study, no one had asked adolescents how often they shared prescription medications,” said lead author Richard Goldworthy, Ph.D., director for research and development at Academic Edge, Inc.

Researchers first asked participants whether or not they had ever loaned or borrowed prescription medications. Those who responded positively were then asked what type(s) of drugs were borrowed, whether they gave or received written or verbal instructions, and whether or not they had shared to avoid a doctor’s visit—74% of borrowers said yes.

Of the 86 teens trying to steer clear of the doctor’s office, 32.4% ended up going anyway when the problem persisted. Herein lies the danger: 43 of them reported experiencing an allergic reaction or other side effect, but less than half of borrowers (about 40%) reported telling their doctors they had used the medication.

Drug sharing has a number of negative consequences. Conditions often worsen when not taken care of in a timely manner, and using medications improperly only increases the danger. Sharing antibiotics, for example, unnecessarily increases bacterial resistance to treatment.

“Other researchers have studied people selling prescription drugs,” said co-author Chris Mayhorn, an associate professor in the Human Factors and Ergonomics Psychology Program at North Carolina State University. “ but we looked at people with good intentions, trying, for instance, to help a friend who lacked money or transportation.”

Taking a friend’s acne medication may seem innocent to a teen, however, drugs such as Accutane increase risk of depression and can cause serious birth defects in he event of an unplanned pregnancy.

The study has provided a greater incentive to boost educational programs, pushing efforts to reduce the growing drug sharing problem by training both patients and providers about proper drug use.

Melissa Haddow, executive director of the Community Partnership of the Ozarks, says, "This work highlights the diversity of medications being abused this way, which had not been recognized (before)."

More about child health.

A study released this week by Baylor University shows that fish caught in five rivers across the U.S. harbor low-levels of several pharmaceuticals, including drugs that lower cholesterol levels, antidepressants, anti-convulsants, and drugs that treat allergies, high blood pressure, and bipolar disorder. The study was the first to examine the levels of pharmaceuticals in freshwater fish on a national scale.

Researchers took fish from rivers in Chicago, Dallas, Orlando, Phoenix, and Philadelphia, all of which collect the outflow from wastewater treatment plants. For comparison, they also tested fish from a river in New Mexico that is unaffected by human pollution.

Scientists tested the fish for the presence of 24 different pharmaceuticals and 12 chemicals found in beauty products. They found trace amounts of seven pharmaceuticals and two chemicals form beauty products in fish at all five river sites. The drugs included gemfibrozil, diphenhydramine, carbamazepine, norfluoxetine, fluoxetine and sertraline. The chemicals they found were galaxolide and tonalide, which are fragrances used in soap and other beauty products. None of the drugs or chemicals were found at the New Mexico river site.

While the amounts of the drugs found in the fish were very low – hundreds of thousands of times less than a therapeutic dose – what has the researchers and the Environmental Protection Agency (EPA) concerned is the effects of long-term consumption of trace amounts of medicines, especially in unknown combinations. Some evidence suggests that combinations of these pharmaceuticals, even in small amounts, could have a negative effect on the growth of human cells.

It is likely that fish absorb the pharmaceuticals because the rivers they live in are contaminated with traces of drugs that are not removed in wastewater treatment plants. Most of the drugs come from the un-metabolized byproducts of pharmaceuticals that people have taken and then excreted, while a smaller amount comes from unused drugs dumped down the drain.

A year ago, a separate study found trace amounts of pharmaceuticals in the drinking water of several major metropolitan areas.

For more information on chemical pollution, join the Healia Online Community for Environmental Health.

_{Photo: kasperbs, Flickr, Creative Commons}

Researchers from the Albert Einstein College of Medicine reported this week that a combination treatment made up of two FDA-approved drugs may be able to treat tuberculosis (TB) that is resistant to standard TB drugs. If true, the new treatment could help hundreds of thousands of people worldwide who suffer from multidrug resistant TB (MDR-TB), which does not respond to the two most common antibiotics used for TB, and extensively drug-resistant (XDR-TB) bacteria that resist at least four of the drugs used to treat TB.

In the study, published Thursday in the journal Science, the researchers used cultures of TB bacteria in a lab to show that the combination of the antibiotic meropenem and another drug called clavulanate is effective against 13 different strains of XDR-TB, the hardest type of TB to treat. The combination also killed MDR-TB and non-resistant TB strains.

The combination in an elegant solution to a vexing problem of TB treatment: the TB bacterium produces an enzyme called beta-lactamase that destroys penicillin-like antibiotics. This required the development of new drugs to treat the disease, most of which were developed in the 1950s and 60s. However, after nearly 50 years of use, TB bacteria have started to develop resistance to these drugs. So the researchers revisited the idea of using penicillin-like antibiotics against TB and developed a way to get around the problem of beta-lactamase. One of the drugs used in the combination, clavulanate, is a beta-lactamase inhibitor. The clavulanate basically acts as decoy molecule that preoccupies the beta-lactamase enzyme, allowing the other drug in the combination, a penicillin-like antibiotic called meropenem, to sneak in and kill the TB bacterium.

Two things make this finding especially exciting to researchers in the field of TB treatment. First, the drugs used in the combination treatment are FDA-approved, which should make it much easier to begin clinical trials on humans, although clavulanate is currently only commercially available in combination with other penicillin-like antibiotics such as amoxicillin.

The other exciting thing is that if this combination treatment proves effective in human, it could greatly simplify the treatment of TB. Current TB therapy requires four antibiotics that must be taken for at least six months. If a combination treatment involving just two drugs works against drug-susceptible, MDR-TB and XDR-TB, it could help could help patients better adhere to therapy and make it easier to treat TB in developing countries, where drug-resistant TB can be rampant.

Plans are underway for two clinical trials, one in South Korea beginning this year and involving approximately 100 XDR-TB patients and a separate trial to be conducted in South Africa.

For more information about TB, join the Healia Health Community for Tuberculosis.

_{Photo: Aidan Jones, Flickr, Creative Commons}