FDA says Yasmin Marketing Material Must Change
FDA says makers of Yasmin must change all promotional material in accordance to the FDA mandated label change. Marketing material must include information on the risk of thromboembolism in women using Yasmin compared to contraceptives using other progestins.
Here is the actual text of the FDA letter:
This “Prior Approval” supplemental new drug application provides for the addition of new information in the Thromboembolism subsection of the Thromboembolic Disorders and other Vascular Problems subsection of WARNINGS. The new information concerns the relative risks of thromboembolism in women using YASMIN compared to those in women using combination oral contraceptives containing other progestins.
Other warnings for women taking Yasmin:
Yasmin Pancreatitis or Kidney Failure.
Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using combined oral contraceptives like Yasmin, Yaz or Ocella. Kidney failure may also be a side effect of using this form of birth control.
Yasmin Heart Arrhythmia or Palpitations
Some women have reported both the development and / or having heart arrhythmia or palpitations, meaning an irregular heartbeat. Medical studies on this condition are ongoing and non conclusive at this period. If you have experienced heart arrhythmia or palpitations and / or were taking Yasmin, contact your doctor at once.
Yasmin has encountered recent problems and has been linked to the development of serious side effects. These Yasmin side effects include:
Deep vein thrombosis (DVT)
Pulmonary embolism (PE)
Blood Clots and enhanced Risk for Blood Clots
Weight Gain
Blood Clots
Depression
Kidney Failure
Seizures
Stroke
Heart attack or death
People have already started filing Yasmin claims from all over the country. If you or someone you know has suffered side effects from taking Yasmin contact a lawyer today.
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