Creative Ways Drug Companies are Changing Drugs of Abuse

The FDA has taken a stance on decreasing drug abuse and pushing for drug companies to find ways to deter people from abusing prescribed medications (crushing, snorting or injecting tablets) or using medications the way they were not intended to be used.

Some of the novel drugs that have been created include:

  • Hysingla is a harder to abuse hydrocodone that deters crushing, dissolving and injection because the contents turn into a thick gel when attempting to dissolve.
  • Targiniq, when crushed and snorted or crushed, dissolved, and injected, the naloxone blocks the euporic effects of oxycodone making it less liked by abusers than oxycodone alone.
  • Embeda is an agonist/antagonist combination of an extended release morphine with naltrexone. Naltrexone is not an active component unless the tablet is chewed, crushed, or dissolved.

Unfortunately, the most common route of abuse of these types of medications is the oral route. This cannot be addressed through the physical component of the tablets on the market but has been combated with changes such as state databases showing trends of prescription opioid fills and refills and also changing hydrocodone from a CIII to a CII causing more regulation and different rules for the pharmacist and prescriber to follow.

 

What is REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system. This resource center contains information for pharmacists, patients, and other healthcare professionals about REMS, and the specific requirements for drugs that require a REMS. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.  Additional REMS Information.

Check out this FDA website to obtain more information.

Four Nutritional Supplement Scams To Stay Away From

Proper nutrition is one of the keys to maintaining good health but, unfortunately, the American diet isn't exactly packed full of vitamins and minerals. Many consumers, as a result, have turned to supplements as a means to offset what they lack from their diets. This enormous demand has given rise to a number of companies interested in selling various nutritional products such as shakes, meal replacement bars and pills.  

Lack Of FDA Oversight For Nutritional Supplements

 

The dietary supplement industry, however, has long benefited from a lack federal regulation when compared to medical drugs, which is why these companies can make numerous empty promises regarding the effectiveness of their products. Moreover, these supplements do not undergo rigorous testing to ensure their purity and potency, which means that consumers could be purchasing an expensive yet worthless product.

 

How To Avoid Fraud

 

Since the rules are rather loose when it comes to the supplement market, fraud comes in many forms. Some products provide modest benefits but are marketed as cure-alls, while others are part of multi-level marketing systems that look suspiciously like pyramid schemes. The worst, however, are the ones that appear legitimate but can cause serious side-effects. Here are a few examples of these common scams:

 

1. The Cure-All

 

California-based POM Wonderful is best known for its pomegranate juice products, though it also sells pills containing an extract. In May, a judge issued the company a cease-and-desist order due to a complaint filed in 2010 by the FTC, which stated that POM Wonderful engaged in false advertising by claiming that its products could prevent serious illnesses such as heart disease and prostate cancer. Unwarranted claims of this kind, unfortunately, are commonplace in the supplement industry, though this ruling suggests that the federal government has begun to pay more attention.

 

2. The "Free Trial"

 

The more exotic the plant, the more likely it will be touted as a miraculous weight loss product. Acai berry supplements supposedly help people lose weight by boosting their metabolisms, but this "proof" stems from testimonials and unknown medical experts. While acai supplements are probably a waste of money, a more serious problem has been the online scams involving these products. Central Coast Nutraceuticals, for instance, was shut down by the FTC after nearly 3,000 customers complained to the Better Business Bureau about receiving numerous credit card charges despite promises of a "free trial" period for its AcaiPure supplements.

 

3. The Pyramid Scheme

 

Multi-level marketing strategies have long been criticized for closely-resembling pyramid schemes because they offer heavy incentives for recruiting other salespeople into the program and tend to have high start-up costs. Herbalife, one of the most successful purveyors of nutritional supplements, has come under scrutiny lately after a Belgian court ruled in January that the company operated as a pyramid scheme. Although the verdict is under appeal, the company's annual reports have drawn further suspicion. In 2005, for instance, the turnover rate for its distributors was 80%, and most of these were lower-level salespeople. This high dropout rate suggests that a great deal of the company's income comes from recruitment instead of retail sales - a common characteristic of pyramid schemes.

 

4. Dangerous Medicine

 

Many pharmacy technician schools now train students to help customers understand the risks that some over-the-counter supplements pose, such as dangerous drug interactions and toxicity from high doses. Supplement companies, however, have been shown to reveal little information about the safety of their products. When agents from the Government Accountability Office (GAO) asked supplement sellers questions such as whether it was safe for people to take garlic with blood pressure medication, or if aspirin interacted with ginkgo biloba, all of them claimed that these herbal supplements were safe even though the National Institutes of Health (NIH) has stated otherwise. Whether these supplements do what they claim or not, they may carry risks that make them not worth taking.

 

Although many supplements have been shown to provide some nutritional or medicinal benefit, they are rarely as powerful as companies claim and some can be downright dangerous. Those who are interested in boosting their health with these products, then, should conduct some research and consult their doctor first before making a purchase.

 

Author byline: Young Lee writes from her hometown of Phoenix, AZ. She hopes consumers are aware of their choices when it comes to nutritional supplements.

The Sun-kissed Glow; The Precancerous Glow

It's that time of year again.  Summer.  Although it is not June 21st yet, it is that time of year where millions of people take a weekend vacation to the beach.  Including my family.  I noticed right away that one of my children seemed to be glowing a bit red where I had missed applying sunscreen.  Not good.  Her little area beneath one eye is pink now and puffy and to be honest, I just don't even look at tans the way I used to. I hate to admit that once upon a time in my teens and twenties, I coveted and regularly paid for tanning appointments.  A tan made me feel thinner which I desperately wanted to be.  My mother regularly tanned as well, though she won't now thanks to a brush with squamous cell carcinoma.  Seriously, if you tan or love to tan, give it up.  It's just not worth it later in life.  Hers looked like a wart.  I think she has at least 10 stitches?  Whatever the outcome, it is not worth it.

So, of course when you get to the beach and see hundreds of people flocking to the beach, you wonder... do people know about sunscreen?  Do they realize that the sunscreen industry is changing and that the FDA is also changing things?

Go ahead and lose the word sunscreen first.  Currently, sunscreen standards relate to UVB sun exposure, the primary cause of sunburns and a contributor to skin cancer and premature aging. Under the FDA's new rules, the sunscreens will also have to be tested and labeled to disclose UVA protection. Radiation from this type of sun ray is more deeply penetrating, passes through windows, and is linked to skin cancer and early aging.

This summer, if the FDA determines that a sunscreen protects both from UVA and UVB, it will be labeled broad spectrum.  Sunscreen will no longer be able to say they are waterproof or sweat proof.  No more labeling that a sunscreen can stay on longer than two hours without reapplying.

The playing field is about to become level, and it is most definitely time.

I personally use Blue Lizard Sunscreen, and I can't say enough good things about it.  My dermatologist recommended it, and I use it daily on my face!

The usual...

Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.