Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel

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Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database

BMJ 2011; 342 doi: http://dx.doi.org/10.1136/bmj.d2139 (Published 21 April 2011)

Cite this as: BMJ 2011;342:d2139

Objective To examine the risk of non-fatal idiopathic venous thromboembolism in current users of a combined oral contraceptive containing drospirenone, relative to current users of preparations containing levonorgestrel.

Design Nested case-control study.

Setting UK General Practice Research Database.

Participants Women aged 15-44 years without major risk factors for venous thromboembolism who started a new episode of use of an oral contraceptive containing 30 µg oestrogen in combination with either drospirenone or levonorgestrel between May 2002 and September 2009. Cases were women with a first diagnosis of venous thromboembolism; up to four controls, matched by age, duration of recorded information, and general practice, were randomly selected for each case.

Main outcome measures Odds ratios and 95% confidence intervals estimated with conditional logistic regression; age adjusted incidence rate ratio estimated with Poisson regression.

Results 61 cases of idiopathic venous thromboembolism and 215 matched controls were identified. In the case-control analysis, current use of the drospirenone contraceptive was associated with a threefold higher risk of non-fatal idiopathic venous thromboembolism compared with levonorgestrel use; the odds ratio adjusted for body mass index was 3.3 (95% confidence interval 1.4 to 7.6). Subanalyses suggested that referral, diagnostic, first time user, duration of use, and switching biases were unlikely explanations for this finding. The crude incidence rate was 23.0 (95% confidence interval 13.4 to 36.9) per 100 000 woman years in current users of drospirenone and 9.1 (6.6 to 12.2) per 100 000 woman years in current users of levonorgestrel oral contraceptives. The age adjusted incidence rate ratio was 2.7 (1.5 to 4.7).

Conclusions These findings contribute to emerging evidence that the combined oral contraceptive containing drospirenone carries a higher risk of venous thromboembolism than do formulations containing levonorgestrel.

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Drosperinone

English: Logo of the . (Photo credit: Wikipedia)

Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

AUDIENCE: OBGYN, Family Practice, Patient

ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

BACKGROUND:  Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

The revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

RECOMMENDATION: Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/10/2012 - Drug Safety Communication - FDA]

Previous MedWatch Alert:

[10-27-2011]

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Contraceptive pill associated with increased prostate cancer risk worldwide

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ABSTRACT
Background: Several recent studies have suggested that oestrogen exposure may increase the risk of prostate cancer (PCa).
Objectives: To examine associations between PCa incidence and mortality and population-based use of oral contraceptives (OCs). It was hypothesised that OC by-products may cause environmental contamination, leading to an increased low level oestrogen exposure and therefore higher PCa incidence and mortality.
Methods: The hypothesis was tested in an ecological study. Data from the International Agency for Research on Cancer were used to retrieve age-standardised rates of prostate cancer in 2007, and data from the United Nations World Contraceptive Use 2007 report were used to retrieve data on contraceptive use. A Pearson correlation and multivariable linear regression were used to associate the percentage of women using OCs,intrauterine devices, condoms or vaginal barriers to the age standardised prostate cancer incidence and mortality. These analyses were performed by individual nations and by continents worldwide.
Results: OC use was significantly associated with prostate cancer incidence and mortality in the individual nations worldwide (r¼0.61 and r¼0.53, respectively; p<0.05 for all). PCa incidence was also associated with OC use in Europe (r¼0.545, p<0.05) and by continent (r¼0.522, p<0.05). All other forms of contraceptives (ie, intra-uterine devices, condoms or vaginal barriers) were not correlated with prostate cancer incidence or mortality. On multivariable analysis the correlation with OC was independent of a nation’s wealth. Conclusion: A significant association between OCs and PCa has been shown. It is hypothesised that the OC effect may be mediated through environmental oestrogen levels; this novel concept is worth further ....... Risk Factor Oral Contraceptive Prostate Cancer

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