PremPro And Increased Risk of Breast Cancer, Heart Attack, Blood Clot and Stroke

>citing the risks to the study's participants.
PremPro was introduced to the market to helpAdditionally, the Women's Health Initiative Memory
ease the side effects commonly associated withStudy (WHIMS), a sub study of the WHI, recently
menopause, however, because of the serious andconcluded that women treated in the study with
harmful risks associated with the hormonePremPro, conjugated estrogens 0.625mg
replacement therapy a study was halted by thecombined with medroxyprogesterone acetate
National Institute of Health (NIH). Women must be2.5mg, have a greater risk of developing probable
aware of the side effects of this drug in order todementia than those on placebo.
protect themselves from breast cancerA recent study by Newcomer et al., which found
developing.that there was a nearly 210 percent risk of
As women age they develop menopausaldeveloping lobular breast cancer among patients
symptoms that may cause serious discomforttaking a CHRT therapy, PremPro, compared to
and irregularities among their daily lives.those not undergoing any type of hormonal
Technology has assisted in the development oftherapy treatment. This risk may be as high as
many treatments and pharmaceuticals to430%.
decrease the menopause side effects, includingAnother large study that was conducted in the
PremPro, which is a combined hormoneUnited Kingdom also was stopped prematurely
replacement therapy (CHRT).because the founders of the study considered it
In July 2002, the National Institute of Health (NIH)unlikely that the trial would provide evidence to
halted a $700 million, eight year publicly fundedinfluence clinical practice in the next 10 years.
study of the benefits of HRT, by The Women'sIn January 2003, Wyeth issued a "Dear Health
Health Initiative (WHI) three years earlier thanCare Professional" letter at the request of the
planned because of the risks associated withFederal Food and Drug Administration (FDA). The
these drugs. Unfortunately, the risks associatedletter detailed the new labeling of PremPro,
with the treatments exceeded the benefits ofincluding a "black box" warning stating that
the drug. Specifically, the study found a higherestrogen plus progesterone therapies should not
incidence of serious injury for women who tookbe used for the prevention of cardiovascular
PremPro compared to those who received adisease.
placebo. The main conclusions of the studyAdditionally, the warning included information from
included:the Women's Health Initiative/National Institute of
* The estrogen plus progestin combination doesHealth study detailing the potential adverse side
not prevent heart disease.effects of taking PremPro, and advised health
* For women taking this estrogen plus progestincare providers to prescribe PremPro for the
combination, the risks outweighed the benefitsshortest duration consistent with treatment goals.
(fewer hip fractures and colon cancers).The FDA has advised manufacturers of these
The study found that long-term use of PremProdrugs to continually update their labels based off
is dangerous because PremPro significantlyof results from the Women's Health Initiative
increases the risk of the following:(WHI). This information will allow individuals to
* Stroke by 41%.understand the risks as they are identified.
* Blood Clots by 113%.In March 2003, the FDA approved a new, lower
* Heart Attacks - Cardiovascular Disease by 22%.dose of PremPro to help with these goals.
* Breast Cancer by 26%.Numerous class action lawsuits have been filed
The risks were so alarming that the NIH canceledbecause of injuries caused as a result of taking
the study in advance of the planned end datePremPro.