Counterfeit Diabetes Medications

Nathan Kawamura, Doctor of Pharmacy candidate Washington State University - July 7, 2011

The Internet allows consumers to shop for deals on anything imaginable, even prescription drugs. The economic struggles that many currently face, paired with the increasing cost of healthcare and prescription drugs, have created an environment in which counterfeit drug makers can prosper.

The drugs offered by counterfeiters can be extremely dangerous, even deadly. Most either have little or no active ingredient, are too potent, and/or have dangerous impurities. According to a 60 Minutes investigation in Peru, highway paint, floor wax, boric acid, and other harmful ingredients were being used to manufacture drugs. These ingredients are a small sample of the potentially dangerous ingredients that have made their way into counterfeit drugs.

The enormous profits earned by counterfeiters are attributable to cheap manufacturing costs along with high resale prices. It is estimated that counterfeit drug rings bring in $75 to $200 billion annually. Profits can exceed those of heroin and cocaine.

Counterfeits are so well made that the pills look identical to the real thing when inspected with the naked eye. Unfortunately, sometimes these look-alikes are deadly. For example, a case in 2009 from China revealed that counterfeit glibenclamide (glyburide in the U.S.) resulted in nine hospitalizations and two deaths. The drugs were shown to have six times the labeled amount of glibenclamide.

Counterfeit drugs are generally more prevalent in Asia, India, and developing countries, but the U.S. is not immune to the threat. 60 Minutes reported, "Forty percent of drugs taken in the country [U.S.] come from other countries, and 80 percent of active pharmaceutical ingredients actually come from other countries."
In the U.S., drug manufacturers sell to authorized distributors who then sell to pharmacies, but this supply chain can become tainted with counterfeit drugs when secondary wholesalers enter the market. Authorized distributors or foreign countries may supply these secondary wholesalers, and it is at this point that counterfeits may enter circulation.

Erectile dysfunction drugs (Viagra, Cialis) and cholesterol-lowering agents (Lipitor) are among the most heavily counterfeited drugs. In 2008, 150 non-diabetics in Singapore presented with severe hypoglycemia after ingesting erectile dysfunction drugs laced with glyburide. Seven remained comatose for an undisclosed amount of time, and four deaths resulted. In 2003, the FDA recalled various lots of counterfeit Lipitor. Although there were no reported deaths or harmful events, this event testifies to the fact that even legitimate distribution channels are vulnerable to counterfeits.

Although the majority of reports are tied to drugs, a case arose in 2006 in which counterfeit glucose test strips made their way into U.S. circulation. The FDA reported no injuries related to the event, but the situation could have seriously harmed patients who used the faulty strips. Falsely high readings may have caused patients to inject unnecessary quantities of insulin, which could have caused severe hypoglycemia and possibly death. Fortunately, this did not occur, but the test strips are yet another example of how counterfeit products can make their way into circulation and the potential severity of the issue.

The problem of counterfeits is more prevalent in less developed countries, but legitimate distribution channels have been breached, and no one is immune to the problem. Internet pharmacies are a prime example of how counterfeits get into the hands of consumers around the world. Internet pharmacies often advertise medications at a fraction of the cost a retail pharmacy would charge, and some even allow one to purchase prescription products without a prescription. The low cost and absence of a prescription are some of the ways these sites market to their potential clientele, but what sometimes slips the mind of the consumer is the potential hazard that comes with these so-called benefits.
The aforementioned cases are only a small sampling of the global problem.

Counterfeits could potentially be found in any pharmacy, but are most likely to be encountered with Internet pharmacies. The consumer should be wary of this and understand some of the signs that may indicate a counterfeit. Counterfeit pills may look or taste differently than usual, may be chipped, may be ineffective (lead to an exacerbation of symptoms), or may have side effects not listed in the drug profile.

Pharmaceutical companies are beginning to use tracking technology on their products to curb the incidence of counterfeits. In 2006, the World Health Organization implemented IMPACT, a task force to combat counterfeiters and protect the consumer. While IMPACT may help the situation, it will not rid the market of counterfeited products. Consequently, consumers, healthcare providers, and various organizations must continue to work together to combat this problem.

References:

1. Darnton et al. The Difficult Fight Against Counterfeit Drugs [Internet]. CBS Interactive Inc; 2011 Mar 10 [Cited 2011 May 25]; [4 pages]. Available from: http://www.cbsnews.com/stories/2011/03/10/60minutes/main20040693.shtml?tag=currentVideoInfo;segmentTitle.

2. Chu, Kathy. Growing Problem of Fake Drugs Hurting Patients, Companies [Internet]. USA Today; 2010 Sept 13 [Cited 2011 May 25]; [ 2 pages]. Available from: http://www.usatoday.com/money/industries/health/2010-09-12-asia-counterfeit-drugs_N.htm.

3. Kao SL, Chan CL, Lim CC, et al. An Unusual Outbreak of Hypoglycemia. N Engl J Med. 2009 Feb 12; 360(7): 734-736.

4. A Serious Threat to Patient Safety: Counterfeit Pharmaceuticals [Internet]. New York: Pfizer; 2007; [16 pages]. Available from: http://www.pfizer.com/files/products/CounterfeitBrochure.pdf.

United States To Pull Diabetic Drug Avandia Off Shelves

May 22, 2011

A recent announcement by the Food and Drug Administration stated that the drug Avandia, commonly used for diabetes treatment, would be pulled from U.S. shelves as of this November. This medication, which has been a favorite for Type 2 diabetics for years, also goes by the name rosiglitazone.

The recall also involves the medication Avandamet, which contains both metformin and rosiglitazone, and Avandaryl, which is made up of glimepiride and rosiglitazone.
Avandia has received some negative publicity since major health risks started being associated with its use back in 2000. The drug has even been blamed for several deaths, sparking a barrage of lawsuits for its maker, GlaxoSmithKline.

By 2006, the number of people taking Avandia were numbered at over 1 million, producing revenue of over $3 billion for the company. But in 2007, a study revealed that those who were taking the medication were witnessing a 40 percent increase in the risk of heart attack, cardiovascular disease and stroke.

One of the studies that was cited looked at data on 35,531 patients. Out of this group, 19,509 had taken Advandia. Evidence showed that individuals who had taken the drug for a period of at least five years had an increased risk of heart attack of between 28 and 39 percent. This translated into a ratio of 1 out of every 37 to 52 patients.

Once word got out that the FDA had placed a warning on the medication, consumers quickly responded. By 2010, sales had plummeted to just over 119,000. According to the FDA, the new guidelines were issued as part of a Risk Evaluation and Mitigation Strategy, or REMS. REMS is meant to be used as a way for the agency to manage certain drugs that may carry serious risks.

Patients will still be able to purchase Avandia from certain pharmacies through mail order. For some individuals, this is the only medication that offers them help in managing their Type 2 diabetes. There are those who wish to continue taking Avandia and do not wish to switch over to the alternate choice of pioglitazone. Along with their physicians, these patients will be forced to attend educational courses concerning the medication before they will be allowed to be prescribed.

GlaxoSmithKline has agreed to pay $460 million to settle a majority of the pending lawsuits against the drug maker.

The Controversy Surrounding Avandia … should you continue to take it or not?

October 25, 2010

European regulators have called for the controversial Type 2 diabetes drug Avandia (rosiglitazone) to be removed from the market. According to the European Medicine Agency (EMA) the benefits of Avandia for Type 2 diabetics no longer outweigh the risks involved and that it should be suspended.

Avandia is commonly used by people suffering from Type 2 diabetes to regulate the level of blood sugar in their body. It is in a class of anti-diabetic drugs called thiazolidinediones … the other drug in this class is pioglitazone (Actos).

Despite warnings about risks of heart failure and its increasing associations with heart problems, Avandia remains popular. Avandia, whose generic name is rosiglitazone, is also used in conjunction with other drugs under the names Avandamet and Avaglim.

A spokesperson for the EMA has stated "Diabetics who are currently taking these medications should make an appointment with their doctor to discuss a suitable alternative treatments. Diabetics though are advised not to stop their treatment without speaking to their doctor."

Although in the US, regulators are only recommending greater restrictions on its use, the decision by the EMA to call for its suspension will lead to further investigation of Avandia by the European Commission before the actual final ruling is given.

The Chief Medical Officer, at GlaxoSmithKline who manufacture Avandia, Dr Ellen Strahlman, has stated: "Our primary concern continues to be patients with Type 2 diabetes and we are making every effort to ensure that doctors in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients”.

In 2009, the American Diabetes Association recommended that doctors prescribe other drugs instead of Avandia for Type 2 diabetes. Also, in the same year 2009, researchers from the Institute for Clinical Evaluative Sciences conducted a study comparing Avandia to its competitor … another drug in the same class called Actos (pioglitazone). This particular study found people taking Actos were at a decreased risk for heart attack and death as compared to those taking Avandia,

GlaxoSmithKline denies the criticisms posed against it and says the evidence does not clearly show that Avandia increases the risk of heart attack or any related events. Interestingly, the FDA released an statement reminding it continues to review the data from the RECORD study, which is currently investigating the safety issues associated with Avandia.

Anyone taking Avandia (especially people with underlying heart disease or at risk for a heart attack or heart failure), were advised to talk to their doctor about the benefits and risks of staying on this drug.