Yaz- Dangerous Drugs & Unethical Marketing~ Article

I don’t want to keep harping on the whole Yaz, Yasmine ordeal, but right now there are so many questions being raised with regards to taking it, I really want to keep the updated info coming.

Again, please do not think I am for or against Yaz, I don’t have any personal information I can offer with regards to it, I haven’t taken it and will not as I have said before.  I don’t do BCP of any sorts, I don’t care how ‘new’ and ‘great’ and ‘different’ they claim to be, I have tried them and they put my PMDD into overdrive.  I don’t have time to ‘test’ if this one will too.

I also don’t usually jump on board with the ‘newest’ and ‘greatest’ drugs, it hasn’t been out long enough with enough long term data for me.  That’s all I will say on the subject.  Some Women love it, others with PMDD have reported to me that it did the same thing to them that other BCP have done.

I am just providing articles and factual info on this site as well as my personal story of living with PMDD.

Stef

This article came from: The Legal RN: Advocating for Patients Rights and Education.  You can read about Paul Parks, RN at his site: www.thelegalrn.blogspot.com

Sunday, August 23, 2009

Yaz, Yasmine and Ocella: Dangerous Drugs and Unethical Marketing Without Regard to Patient Safety By Paul Parks RN LNC

If you have read my articles you know that I find direct to consumer advertising one of the most egregious acts among pharmacuetical companies in this country. God forbid if I told you there was an innocuous plant or herb that has never killed one person in world history and when ingested was useful for many common problems from insomnia to anxiety, glaucoma to pain relief without narcotic addiction or deadly side effects and was proven to work, I probably would be thrown in jail for advocating drug use. Yet every day we see commercials with pretty boxed packaging advocating for you to use a dangerous drug (without your knowledge) and for your doctor to write you a RX for it. If you think doctors know everything about the drugs they give you think again. Pharmaceutical reps come in and give the doctor and staff a quick in-service about the drug with a nice lunch provided of course and then on to the next prospect (I have done medical sales in the past) so I know how the game is played. Unfortunately for patients they are the ones who suffer in the long run….just ask a few patients who took Vioxx or Phen-Phen and are now cardiac cripples or dead. What You need to know about Yaz, Yasmine and Ocella: Yasmine is considered a wonder drug among the OB/GYN community. What is not so wonderful is that it is harming and killing some people as I write this article. How these drugs differ from other birth control pills-

Drospirenone and Ethinyl Estradiol is a type of birth control pill that combines two hormones: the lowest dosage of ethinyl estradiol commonly used today and drospirenone, a different type of progestin. Drospirenone is a compound closely resembling progesterone, but has properties that are closely related to spironolactone, a diuretic drug used to treat high blood pressure. Drospirenone and Ethinyl Estradiol was approved by the Food and Drug Administration on May 11, 2001.

Drospirenone and Ethinyl Estradiol not only prevents pregnancy but also results in shorter, lighter periods, reduced cramps and a regular menstrual cycle. It also helps with some symptoms of premenstrual dysphoric disorder (PMDD) and helps control mild to moderate acne breakouts. How the drug works :

Combination pills like Drospirenone and Ethinyl Estradiol, which contain two types of hormones (an estrogen and a progestin), work in two ways:

• The body is “tricked” into thinking it is pregnant. This prevents the release of an egg, or ovulation. Without an egg to be fertilized, a woman cannot become pregnant. The estrogen part of the pill is what makes the body “think” it is pregnant so that it doesn’t release eggs.

• The cervical mucus is thickened, making it difficult for sperm to travel toward the egg and fertilize it in case an egg is released. The progestin part of the pill prevents the ovulation. Other alterations include cervical mucus which prevents the movement of sperm. This serves as a backup to prevent pregnancy even if an egg is released.

Real dangers of psychiatric problems, pulmonary embolism and death - During the brief time that Yasmin and Yaz have been sold in the United States, hundreds of reports of injury and death have been filed with the Food & Drug Administration (FDA) in association with the use of these products. In fact, in less than a five year period, from the first quarter of 2004 through the third quarter of 2008, well over 50 reports of death among users of Yasmin and Yaz have been filed with FDA. These include numerous deaths with reported cardiac arrhythmia, cardiac arrest, intracardiac thrombus (blood clots in the heart), pulmonary embolism (blood clot in the lungs) and stroke in women in their child bearing years. Some of the deaths occurred in women as young as 17 years old. Significantly, reports of elevated potassium levels are frequently included among the symptoms of those suffering fatalities while using Yasmin or Yaz.
Overpromotion of the drug and being less than truthful- Yasmin and Yaz were originally manufactured and distributed by Berlex Laboratories, which was purchased by Bayer Healthcare in 2006. Prior to the sale to Bayer on July 10, 2003, the FDA issued a warning letter to Berlex Laboratories, ordering it to immediately discontinue a misleading television ad for Yasmin. In this ad, the company promoted Yasmin’s fourth generation progestin by stating, “Ask about Yasmin, and the difference a little chemistry can make.” Your damn right about the difference a little chemistry makes here’s a list of some of the side effects and warnings of this “cool” sounding and looking drug:

Drospirenone and Ethinyl Estradiol differs from other birth control pills because it contains a progestin hormone called drospirenone. Drospirenone can increase potassium in the bloodstream. Women should not use Yasmin if they have kidney, liver, or adrenal disease because it can cause serious health problems. Also, Yasmin should not be used by people who have:

• A history of heart attack or stroke
• Blood clots in the legs, lungs (pulmonary embolism), or eyes
• A history of blood clots in the deep veins of the legs (deep venous thrombosis)
• Chest pain
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
• Unexplained vaginal bleeding
• Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill
• Liver tumor (benign or cancerous)

some women are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking Drospirenone and Ethinyl Estradiol increase significantly if the person:

• Smokes
• Has high blood pressure, diabetes, or high cholesterol
• Has or has had clotting disorders, heart attack, stroke, chest pain (angina pectoris), and cancer of the breast or reproductive organs, jaundice, or malignant or benign liver tumors.
• Is currently on a potassium-sparing medication or potassium supplements

Potential Drug Interactions

All medicines being taken should be reviewed with a doctor, including herbal supplements and non-prescription medicines. The doctor must be told of long-term treatment with any of the medicines below, because a blood test may be needed to find out if Drospirenone and Ethinyl Estradiol is recommended.

• NSAIDs:— ibuprofen (Motrin, Advil), naproxen (Naprosyn, Aleve, and others) when taken long-term and daily for treatment of arthritis or other diseases or conditions
• Potassium-sparing diuretics (spironolactone and others)
• Potassium supplements
• ACE inhibitors: captopril (Capoten), enalopril (Vasotec), lisinopril (Zestril), and others
• Angiotensin-II receptor antagonists: losartan (Cozaar), valsarta (Diovan), irbesartan (Avapro), and others
• Heparin

When Drospirenone and Ethinyl Estradiol is taken with St. John’s wort, rifampin, anticonvulsants, or antibiotics, the efficacy of Yasmin is decreased, and could potentially lead to contraceptive failure. An alternate method of birth control should be used if the medications must be taken together.

More False Advertising: The FDA objected to the characterization that drospirenone was a benefit compared to the progestin used in other COCs, stating, “FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, the FDA is aware of the added clinical risks associated with drospirenone . . .” Further, the FDA found that the advertisement “fails to communicate that the potential to increase potassium is a risk” or that “increased serum potassium can be dangerous.” Then again on October 3, 2008, the FDA issued a Warning Letter to Bayer, for another false and misleading advertisement concerning Yaz. The FDA found that Bayer was attempting to broaden the indication for Yaz to include PMS (premenstrual syndrome), as opposed to the less serious condition of PMDD (premenstrual dysphoric disorder.) The FDA reiterated that the marketing was misleading because it promoted YAZ for medical conditions beyond the limits of the FDA approval. But also, the FDA held the ad misleading because it failed to disclose that “YAZ has additional risks because it contains the progestin, drospirenone . . . which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems.”

This article is not meant to scare but to educate you as to know about what you ingest in to your body as well as being a realist when it comes to medicine- If it sounds to good to be true it probably is, even in medicine. You must also consider the fact these drugs have off label uses- not just for birth control and have the same side effects:

• sudden numbness or weakness
• confusion
• pain behind the eyes
• problems with vision, speech, or balance
• chest pain or heavy feeling
• pain spreading to the arm or shoulder
• nausea, sweating, general ill feeling
• change in the pattern or severity of migraine headaches;
• stomach pain
• loss of appetite
• jaundice (yellowing of the skin or eyes)
• a breast lump
• symptoms of depression, including sleep problems, weakness, mood changes
• breast pain, tenderness, or swelling
• freckles or darkening of facial skin
• increased hair growth, or loss of scalp hair
• changes in weight or appetite
• swelling of the hands or feet
• problems with contact lenses
• vaginal itching or discharge
• changes in menstrual periods
• abdominal cramps and bloating
• nausea
• headache

Stop using this medication and call your doctor at once if you feel short of breath, have sudden numbness or weakness on one side of the body, sudden headache, confusion, or problems with vision, speech, or balance. Call your doctor right away if you have a breast lump, unusual vaginal bleeding, or jaundice (yellowing of the skin or eyes). Be aware that you have rights and choices, get a second opinion there are birth control drugs that are much safer remember that this drug causes birth defects. If you or a loved one is taking this drug talk with your doctor about changing to another pill there are plenty of other options that don’t’ have such a high risk for cardiovascular problems. In conclusion Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Taking the combination of drospirenone and estradiol may reduce this risk. Talk with your doctor about your individual situation, and report any unusual vaginal bleeding right away. If you or a loved one have been injured from this drug it is your right to file a claim, there are many class action suits involving these drugs and the list of injured patients continue to grow as big pharma continue to invade your living room with claims of the new wonder drug filling their pockets with billions at our expense.

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