A few weeks ago, I announced in this blog post that I intended to try YAZ to help my PMDD as well as some other hormonal imbalances I had. I felt the addition of a small amount of estrogen and also the specific mechanisms of the special progestin drospirenone in YAZ would be a good fit for my particular health issues.  After doing a bit more research however, I have changed my mind and decided NOT to go ahead with it for the following reasons: a) risk of blood clots; b) increased gallstone formation; c) risk of hyperkalemia leading to cardiac arrhythmias; and d) citation of the manufacturer’s facility by the FDA for contamination and inadherence to Standard Operating Procedures.

RISK OF BLOOD CLOTS

All dual-hormone oral contraceptives carry a risk of increased blood clots. This is why women over the age of 35 and who smoke are advised not to use birth control pills. What concerns me, however, is the number of younger women, who are non-smokers, who have developed life-threatening and fatal blood clots while using YAZ. This recent study indicates a 6.3-fold risk of embolus with drospirenone use compared to those not using oral contraceptives. There is a lawsuit pending against Bayer Schering Pharma at the moment due to pulmonary embolism allegedly caused from YAZ. You can read the complaint here. There is also a class-action suit in the works for women who have taken YAZ and suffered vascular side effects or death. I do not have any history of any vascular issues personally, but until this is addressed, I do not want to take the chance of having a stroke, heart attack or pulmonary embolism due to a medication that is not absolutely necessary for me.

GALLSTONES

YAZ has been shown to increase the risk of gallbladder disease and pancreatitis, and increase the formation of gallstones. It is thought that the hormones in YAZ increase cholesterol in the liver and reduce gallbladder constriction which allows bile to build up in the gallbladder and allow stones (which are made from cholesterol) to precipitate out. I already have existing gallstones and I cannot put myself at greater risk of having a bile duct obstruction which may require surgery as I am uninsured at this time.

HYPERKALEMIA

Drospirenone has been shown to increase risk of hyperkalemia (elevated potassium). This is due to the spirinolactone-type mechanisms of the drug which reduce water retention and also reduce androgenic activity. However, hyperkalemia leads to cardiac arrhythmia and possibly heart attack as well as neuromuscular problems. It is relatively rare, but I have chosen not to take the chance of damaging my heart. Please be aware if you do take YAZ that NSAID pain relievers such as Aleve (naproxen) and Motrin (ibuprofen) can also increase potassium levels in the blood. Do NOT take NSAIDs with YAZ to reduce your risk of developing hyperkalemia.

FDA CITATION

The Bayer manufacturing facility in Bergkamen, Germany that produces YAZ was inspected by the FDA in March 2009 and issued a warning for various violations including producing and distributing API (active pharmaceutical ingredient) product which was out of specification; and also that API may have been adulterated by contamination due to improper cleaning of equipment. See the second Warning Letter here. There were other concerns as well. While I am aware that no manufacturing facility is perfect, the fact that FDA found enough violations to warn them twice is concerning. Along with the other issues I have discovered about the side effects of YAZ, this was pretty much the icing on the cake.

All prescription medications have risks. As a Certified Pharmacy Technician I am well aware of that fact. I believe YAZ can be used successfully for many women. If every woman taking YAZ or Yasmin were dropping like flies from DVT or heart attack, clearly it would be totally recalled. That has not happened. It is my personal choice however, based on evaluation of the risks and benefits for my personal health situation, that I choose not to take it at this time. I will be interested to hear of other’s stories – successes and failures – and your experiences with YAZ. And I will also continue to watch the lawsuits and FDA evaluation regarding this drug. As always, BE YOUR OWN ADVOCATE as I have just demonstrated!

To the best of your health!

~Lori