DRUG DECEPTION BY OMISSION

The new drug Lybrel has been approved for contraception and menstrual period suppression in females. Every news release has been “praising” this drug that stops women from naturally menstruating. Why would anyone want to do this? Will it be targeted to our teenage women of tomorrow who are too busy for a period? How will it react with the mandatory HPV vaccine?

Out of all the reading I did, I failed to come up with concrete information on the side effects in any news articles. There was one statement, “The Lybrel safety and efficacy study was published in the December 2006 issue of the journal Contraception”. This study was supported by a grant from the drug maker. How many patients have access to this? Will the prescribing doctor have the information to pass along?

Finally at www.ocregister.com (Orange County California newspaper) there was this:
"Side effects: Irregular menstrual bleeding. Rare side effects of Lybrel included gallbladder inflammation, blood clots in deep veins, ectopic pregnancy, prolonged vaginal bleeding and enlarged uterine fibroids. There's concern over whether women might irreversibly lose bone density when periods are suppressed for a long time."

The drug manufacturer’s website has a 25 page insert that should come with the prescription called “Information for the Patient – Brief Summary Package Insert”. It states that “the symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills”. There is a section, detailed patient labeling, that cites more side effects and risks. How many patients will receive this from their doctor who has access to 48 pages of "prescribing information"? The prescribing information has 15 pages that include adverse reactions not mentioned in the patient insert. There are also warnings, a black box warning, and precautions. The "brief summary patient package insert" is included in the prescribing information.

Clinical trials revealed that the pill was effective completely in 59% while 41% had breakthrough bleeding. So there is a 41% chance that the patient taking this medication may not get the intended results - continue bleeding and get pregnant. The patient may not realize that she is pregnant, and still be taking the drug. There is a warning about this possibly occurring with this “contraceptive stop-your-period pill”.

Does this make sense? Drug deception by omission – is it okay?

The insert closes with the following statement:
"If you want more information about birth-control pills, ask your health care professional or pharmacist. They have a more technical leaflet called the Professional Labeling which you may wish to read. This product’s label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556."

Be sure to get a copy of the drug insert and prescribing information that comes with the medication from your doctor and/or pharmacist. Get out a magnifying glass to read the tiny print, and a medical dictionary to look up the medical terms. Look it up on the Internet at the drug manufacturer's website for easier reading and more details.