New Breast Cancer Drug and New Caution for Sleeping Medications
Monday, March 19, 2007
Ijeoma Eleazu, PharmD
There's new hope for women with certain types of advanced metastatic breast cancer (that's breast cancer that has spread from the original site) and it's called Tykerb. Tykerb can be used in women who have received other types of drug treatments for their breast cancer; it is what is known as a new molecular entity (NME) which means it is an active ingredient that has never before been marketed in the US in any form. It works in a completely different way from the other drugs and for this reason offers new hope for those who have tried them and are no longer benefiting from them. Tykerb is to be used in combination with Xeloda, another cancer medication, as clinical trials found that this combination was much more effective than using Xeloda alone.
As with most drugs, some side effects were reported with the use of this drug. Some of the more common ones were nausea, vomiting, diarrhea, rash, and hand-foot syndrome. Hand-foot syndrome is a side effect that occurs quite frequently with the use of certain chemotherapy drugs, symptoms of hand-foot syndrome include discomfort, tingling, redness, swelling and numbness in the hands and feet. A few patients who used Tykerb also experienced shortness of breath.
Hear ye, hear ye all insomniacs, there are new labeling changes coming for some drugs used to treat this disorder per a request from the FDA to the manufacturers of these drugs. The FDA wants all manufacturers of sedative-hypnotic drugs aka sleeping pills to be a bit, well a lot, firmer about some potential side effects associated with using them. In particular they want warnings about anaphylaxis, which is a severe allergic reaction to the drug and also possible severe facial swelling to be emphasized. Also, "complex sleep-related behaviors" which can include driving, making phone calls, and preparing and eating food all while asleep.
What's the reason behind this you ask? Well, once a drug hits the market the manufacturers continue to collect information about side effects, adverse reactions, etc and track and report trends in order to either update their labeling or to look good... Anyway, when big brother FDA sees something that concerns them they decide if they need to take action and if so, what specific action to take. That's what happened in this case and because there are differences in the various sleeping medications the FDA even went as far as to request that the drug manufacturers do more clinical studies to find out how often these complex sleep-related behaviors occur with their individual drugs.
Thirteen (13) medications in particular have been singled out for the revised labeling and they include Ambien and Ambien CR, Butisol, Carbrital, Dalmane, Doral, Halcion, Lunesta, Placidyl, Prosom, Restoril, Rozerem, Seconal, and Sonata. More information and Patient Medication Guides are available from your doctor, pharmacist or other healthcare provider...talk to them, they're there to help.
Photos courtesy of merfam and antian
5 Comments:
At Sat Mar 31, 09:36:00 AM 2007,
Kim said…
I've seen two patients in my ER who are under the influence of Ambien who are combative, cussing and totally out of control - with no idea of what was happening to them. No alcohol or drugs on board (via tox screen). Both "woke up" about three hours after taking it and eventually came back to normal as it wore off. These were normal people - scared the heck out of their families.
And then there is my friend who, after taking Ambien, got up and made herself a peanut butter sandwich and decided to paint herself with peanut butter, too. She woke up covered in in and retraced her steps. True story!
At Tue Apr 03, 09:16:00 AM 2007,
Ijeoma Eleazu, PharmD said…
Thanks for sharing your story Kim. I know there must be hundreds more out there for the FDA to feel it necessary to step in!
At Tue May 15, 07:19:00 AM 2007,
Anonymous said…
If these sleeping pills are removed from the market, I don't know what I will do. I break 10mg pills of Ambian in half, and it really helps me get to sleep. Falling asleep is almost impossible for hours on end when I don't. One night I couldn't get to sleep, my mind racing from one thing to another, tossing and turning, and then restless leg would kick in sometimes too. Anyway, this particular night, I turned on the light finally to take another half a pill. Lying on the floor next to my bed was the half pill I thought I had taken. It's up to people what medications they want to try. Adequate warnings are the only thing necessary. Allergic reactions are no ones fault, and no one should be sued. They made the choice to use them. So many, many more, people are helped by medications that the few who have adverse reactions should not be able to sue a company, should not be able to get the medications off the market. I had allergic reactions to Celebrix and Viox, and simply stopped taking either of them. I sincerely hope these sleeping meds never go away. Oh, over the counter sleeping pills give me what is called codine nightmares.
At Tue May 15, 04:11:00 PM 2007,
Ijeoma Eleazu, PharmD said…
Hi Anonymous and thanks for your comment. It is somewhat of a Catch-22 when it comes to these things. Hopefully the FDA can come to a happy medium on these drugs such that neither those who benefit from them nor those who are at greater risk of experiencing adverse effects have to suffer one way or another.
At Wed Jul 11, 08:51:00 AM 2007,
ankh said…
excerpt from breastcancer.org: "An interim analysis done in March 2006 showed that Tykerb combined with Xeloda doubled the time until the cancer grew, compared with Xeloda alone, in women with advanced, HER2-positive breast cancer that had stopped responding to Herceptin. The women who took Tykerb and Xeloda went about 8 and a half months before the cancer progressed. Women who took Xeloda alone went about 4 and a half months. This difference was statistically significant, which means it was probably because of the Tykerb and not just due to chance." and "Tykerb doesn't have any side effects related to heart problems"
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