Public Citizen Warns Of The Dangers Of Savella

A few months ago, we published blog posts on the dangers of Yaz birth control pills.  We also pointed out that Public Citizen, a consumer rights group based in Washington, D.C., had petitioned the Food and Drug Administration (“FDA”) to remove the medication from sale.  According to another recent petition the consumer group sent the FDA, Public Citizen has requested that Savella, manufactured and sold by Cypress Bioscience, Inc. and Forest Laboratories, Inc. and used to treat fibromyalgia, be removed from the market immediately because its dangers outweigh its benefits.

 

Public Citizen alleges that Savella has highly questionable clinical efficacy and has been found, in randomized controlled trials, to cause a large number of potentially serious adverse reactions including hypertension, increased heart rate, and increased suicidal ideation.

 

In its petition, Public Citizen notes the European Medicine Agency, as of July 23, 2009, turned down the application for Savella for the treatment of fibromyalgia, citing both the lack of efficacy and data on long-term effects.  After the drug's sponsors challenged that decision, the European Medicine Agency reconfirmed its original decision.  Public Citizen’s petition states that the “FDA should never have approved Savella for fibromyalgia, and should now immediately undo its error by removing it from the market before large numbers of people in this country suffer serious harm from this marginally effective drug.”

 

If you were injured as a result of taking Savella, please contact us to discuss your legal options.

Recent Clinical Studies Warn Of The Dangers Of Yaz And Yasmin

A couple of months ago, we published a blog post on the dangers of Yaz and Yasmin birth control.  Since then, the results of clinical studies regarding this new class of birth control pills have been published in peer reviewed medical journals, and their conclusions are not encouraging for the millions of women who are currently taking Yaz or Yasmin.

 

For example, two studies published in August in the British Medical Journal found a higher risk for blood clots in women taking the newer progestins like the drospirenone found in Yaz and Yasmin.  Birth control pills work by altering a woman’s hormone levels, and researchers have long known that taking a combination hormone birth control pill which contains estrogen and a progestin hormone can increase the risk of stroke and blood clots in the legs and lungs.  Yaz, which contains drospirenone and a lower dose of estrogen, was approved by the FDA in 2006 and has been aggressively marketed by Bayer since then.  But because drospirenone can increase potassium levels in the body, it may put women who have liver or kidney problems at risk for serious heart problems, including possible liver or kidney failure.

 

The combination of estrogen and drospirenone found in Yaz also affects a woman’s hormonal level in a way that previous classes of birth control pills did not, and may also cause bouts of severe anxiety, depression and other mental health issues.  Indeed, Dr. Frits Rosendaal, the author of one of the studies published in the British Medical Journal, said the adverse reports regarding Yaz and Yasmin were worth acting on – by switching to the older class of birth control pills containing levonorgestrel.  “Even if the risk of thrombosis is low, why not choose the lowest risk, just in case?” he said.

 

If you were injured as a result of taking Yaz or Yasmin, please contact us to discuss your legal options.

Call for Ban of Yaz, Yasmin and Ocella Birth Control

Health and consumer advocates are calling for the Food and Drug Administration ("FDA") to ban Yasmin, Yaz and Ocella -- brand names under which the birth control drug combination drospirenone and ethinyl estradiol are sold -- because of the pill’s potential to cause blood clots, heart attack and stroke.  Yasmin, for example, was introduced in the U.S. in 2001 and is now also available as a generic.  Revenues from Yasmin sales are reported to have reached $500 million in 2007, and its popularity can be attributed to the fact that some unpleasant side effects of other birth control pills, such as acne and unwanted hair, are diminished.  But some Yasmin users have allegedly reported serious health impacts, including inability to conceive after stopping use as well as heart and other health problems.  Indeed, Public Citizen petitioned the FDA in 2007 to ban the Yaz birth control pill for similar reasons.

 

If you have taken Yasmin, Yaz and/or Ocella and experienced adverse health impacts, contact us to discuss your legal options.