Angeliq drug samples mistakenly provided as birth control pills
Most people are thankful when they leave the doctor’s office with samples of a newly prescribed medication. That can make sure that you tolerate the medicine and that it’s working as expected before you pay for a prescription. But there are some hidden dangers. Samples are packaged in a way that can often be confusing and lead to medication errors. Here's a case study that shows what I mean.
Most people are thankful when they leave the doctor's office with samples of a newly prescribed medication. When your doctor wants you to try a new medicine, he may be able to give you a small supply of samples to take home. This way, he can make sure that you tolerate the medicine and that it's working as expected before you have to pay for a prescription. Samples may save you a trip to the pharmacy, too.
Unfortunately, there are some hidden dangers with samples. One problem is that samples are packaged in a way that can often be confusing and lead to medication errors. Also, since your pharmacist isn't involved, there's also no pharmacy label with instructions.
Angeliq is a hormone-based medicine used to relieve the symptoms of menopause, such as hot flashes, night sweats, and vaginal symptoms. Our sister organization in Canada, ISMP Canada, has received two reports of Angeliq being confused for birth control pills. The drug is also available in the US, although we haven't received any similar error reports yet. In each of the cases in Canada, a doctor gave a woman some sample packets of Angeliq to take as birth control, even though that is not the purpose. Each of the women took Angeliq for several months until the samples were finished. The mistakes were discovered when the women took prescriptions for a further supplies of Angeliq to their pharmacy, where they referred to these as "birth control pills."
Angeliq has a number of similarities to birth control pills that might have played a role in the mix-ups. The labelling and packaging of Angeliq is similar in design to the labelling and packaging of birth control pills. Also, Angeliq comes as a punch card (called a "blister pack") with a 28-day supply. You have to punch out each day's pill from the card, just like many birth control pills. The term "Angeliq" sounds like a woman's name and many birth control pills also have female-sounding names (for example, Alesse, Portia, Yasmin, and even Yaz). In addition to these similarities with birth control pills, neither the outer nor the inner package of the Angeliq sample package has any information pointing out that the medicine is to be used for symptoms of menopause.
The hormones contained in Angeliq pills appear similar to the ingredients in birth control pills. Angeliq contains a hormone known as a progestin and it also has an estrogen component, similar to what you'd find in birth control pills. However, the dose of progestin in Angeliq is less than that used in birth control pills, and the potency of the estrogen used in Angeliq is also different from the potency used in birth control pills. So the pills are not suitable for birth control. In fact, if a sexually active woman who has not yet reached menopause uses Angeliq instead of an oral contraceptive, she could become pregnant. So obviously, the consequences of the mix-up have very serious implications.
When samples are provided in doctor's offices, proper labeling and certain checks that are usually provided by your pharmacy may be missed. If your doctor gives you sample medication for any reason, let your pharmacist know you are taking the medication, and why. Your pharmacist can add this information to your medication profile, and check that the sample medication does not interact with any medicines you are already taking. You should also ask your pharmacist to provide you with an information sheet about the medication, if available.
Since 2008, the Institute for Safe Medication Practices (ISMP) has published QuarterWatch, a program that allows us to look at medication errors and serious side effects reported to the US Food and Drug Administration (FDA) during specific 3-month periods each year. The primary goal of the program is to improve patient safety through the identification of signals that may represent serious safety issues with medications. The term signal means evidence that, in our judgment, is substantial enough to warrant further investigation to determine frequency of occurrence and establish a causal relationship to the suspect drug. We report these potential safety problems to FDA and the companies that make the medicines and we also let your doctors, nurses, and pharmacists know about them by getting the word out to the public through professional media and news reports.
Last week we published QuarterWatch for the third quarter of 2010. Of note, one of the drugs that stood out was Chantix (varenicline), the stop-smoking drug which is heavily advertised on TV. Since 2009, Chantix has carried a boxed warning in its labeling about a possible association of Chantix with suicidal thoughts and aggressive behavior. Prior to the third quarter last year, FDA's adverse-event database had shown 37 suicides reported to the agency by the manufacturer, Pfizer, and an additional 85 reported by consumers and doctors. During third quarter 2010, we found that hundreds of older serious psychiatric adverse event reports regarding Chantix were not initially entered into the FDA Adverse Event Reporting System (AERS) by Pfizer per usual procedure. Most notable were 150 cases of completed suicides, some dating back to 2007.
In brief, when a drug company learns of a patient’s death, an “expedited” report is normally submitted to FDA within 15 days and flows automatically into AERS. But for unknown reasons, Pfizer classified these suicides among less serious injuries and submitted them amid hundreds of other less serious reports as an appendix to a quarterly text report intended for page-by-page reading. So the reports were not entered into the FDA Adverse Event Reporting System (AERS) as FDA expected.
Thus, until July 2010, when FDA asked the manufacturer to resubmit "thousands" of reports that were reported in periodic summary reports to the agency's AERS system (http://online.wsj.com/article/BT-CO-20110519-713714.html), safety analysts were not aware of more than half of the reported suicide cases in which Chantix was the primary suspect drug, and did not have available hundreds of other reported cases of serious psychiatric side effects. So much missing data could have led to an underestimation of the risks of Chantix.
In response to our QuarterWatch publication last Thursday, FDA posted a statement (http://www.fda.gov/Drugs/DrugSafety/ucm255918.htm) acknowledging that the reports were initially sent to the Agency in a way that did not allow for comprehensive evaluation. They also noted that a few other manufacturers were also submitting some adverse-event reports through "improper" channels.
FDA said that the reports about Chantix confirmed what they already knew about Chantix and would not have changed the Agency's position on the drug's risks and benefits, given that the data in these reports were consistent with those that led to the 2009 labeling change. They are continuing to monitor the drug’s safety. FDA said they also initiated additional post-market safety activities such as requiring Pfizer to conduct a large, comparative, post-market clinical trial assessing the safety of Chantix among other smoking cessation aids. FDA has also initiated two observational safety studies on Chantix, one with the Veterans Administration and one with the Department of Defense.
When we first examined varenicline data in 2008, reports for this drug outnumbered reports for all other US prescription drugs, although dispensed prescriptions and reported events later declined. Now, with a spike of 1,055 serious ADEs reported in the third quarter of 2010, varenicline again surpassed all other drugs we regularly monitor and also ranked first in reported deaths—more than twice as many as any other drug.
Two other drugs also presented safety signals during Q3 2010. One of these was the new diabetes drug Victoza which was associated with reports of pancreatitis. FDA approval of this drug was controversial because of uncertainty about its cardiovascular risks, and because animal studies showed an increased risk of thyroid cancer. Early adverse event reporting did not speak to these still unresolved issues, but did reveal a marked signal for pancreatitis. Evidence accumulates that similar drugs like Januvia and Byetta may all share an elevated risk of pancreatitis, although possibly to differing degrees.
Signals were also seen with Seroquel (quetiapine). The drug shares with other antipsychotic drugs the risk that some of its most common side effects can be irreversible, notably some cases of diabetes and certain movement disorders. In the third quarter of 2010 we noted hundreds of new reported cases of diabetes associated with QUEtiapine, together with a smaller number of reports of dyskinesia (involuntary muscle movements), dystonia (spasms or prolonged contractions), and parkinsonism (tremors or muscle rigidity). You can find our full report here (http://www.ismp.org/Newsletters/acutecare/articles/20110519.asp).
Most of the time medicines provide much needed benefits to consumers when used safely. However, there is a great need for better communication and management of risks associated with medicines. The best recommendation we can give to consumers is to be informed. Discuss all your options with your doctors and pharmacist, and ask about the serious side effects of medicines. I highly recommend that you sign up for customized safety alerts for the medications you take (https://www.consumermedsafety.org/medsafetyalert.asp). In this way you can help make the most informed decisions about your healthcare.