Healthline Connects
Healthline Connects

New Breast Cancer Drug and New Caution for Sleeping Medications

It's been a busy and quite exciting week in the world of pharmaceuticals. Actually, that may be a bit of a redundant statement because the world of pharmaceuticals is always exciting...but then again, maybe I'm just biased.

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
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The Healthline Editorial team writes about the latest health news, policy, and research.

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