Yaz, Yasmin and similar birth control pills need stronger blood clot information, according to the U.S. Food & Drug Administration (FDA).

Advisers to the health agency issued a recommendation that labels for the popular, newer generation oral contraceptives, including Yaz and Yasmin, indicate that the drugs may put women at increased risks for dangerous blood clots. Yaz and Yasmin contain drospirenone, a controversial progestin that lawsuits allege has led to serious side effects, including deep vein thrombosis and pulmonary embolism, as well as heart attack, stroke, and gall bladder disease. (more…)

The former head of the U.S. Food & Drug Administration (FDA) says Bayer hid controversial birth control, Yasmin’s, blood clot risks.

A growing body of research has revealed that an increased risk of dangerous blood clots—venous thromboembolisms (VTEs)—have been linked to use of Yaz, Yasmin, and other drospirenone-containing contraceptives. Last month, the FDA issued a warning concerning drospiernone-containing oral contraceptives and stated that these drugs increase blood clot risks by 74% when compared to older birth control pills.

Health issues linked to Yasmin and Yaz include stroke, deep vein thrombosis, pulmonary embolism, heart attack, and gall bladder disease.

Now, according to Bloomberg News, former FDA commissioner, David Kessler, has said that a Bayer AG unit hid information from U.S. regulators about its company’s research findings that discussed increased blood clots in people taking Yasmin. In a just-unsealed document—opened in federal court in Illinois—Kessler said that Bayer did not include a 2004 analysis of a Yasmin safety review provided to the FDA “that demonstrated an increase in the U.S. reporting rate” for VTEs or clots, Bloomberg News explained.

Also, the report was submitted with the exclusion of a prior draft opinion authored by company researchers that stated that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” versus other oral contraceptives, said Kessler, quoting the draft, wrote Bloomberg News. Kessler continued, saying, “Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.” Kessler also touted Yasmin for unapproved uses, particularly for treatment of premenstrual syndrome, Kessler added, wrote Bloomberg News.

The information comes in advance of the FDA’s public hearings on Yasmin, which are scheduled for December 8 in Maryland. The hearing will consider the drug’s safety and the controversial progestin, drospirenone and is being headed jointly by the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

In the U.S., over 10,400 individual lawsuits have been filed over Yasmin and Yaz. The lawsuits allege that Bayer did not appropriately warn patients and doctors about increased health risks associated with the drugs, versus safer oral contraceptives.

The majority of those lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently waiting to be heard before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

Bloomberg News pointed out that court papers indicate that women suing Bayer over its Yasmin birth control line allege that Bayer and its units went to extraordinary lengths to advertise the drugs for unapproved, off-label uses. In 2008, the FDA cited Bayer for Yaz TV ads that minimized the drug’s serious risks, mandating it spend millions on a corrective advertising campaign.

Shareholders just announced they are suing Abbott Laboratories over a proposed Depakote settlement. The shareholder derivative action was filed this week in Illinois federal court.

According to a post on the Shareholders Foundation web site, the lawsuit was filed over alleged breaches of fiduciary duty associated with alleged off-label marketing of Depakote. The lawsuit claims that the illegal marketing cost Abbott $1.3 billion in a settlement with the United States Government and 24 states. (more…)

Yaz documents indicate that Bayer might have pushed the Yasmin family of birth control pills for off-label uses. In doing so, drug giant Bayer AG, likely misled women about the drugs’ side effects and health risks.

Company files show that Bayer’s Berlex Laboratories Inc. unit officials touted Yaz to treat all types of premenstrual syndrome; however, the oral contraceptive was only approved in the U.S. for the treatment of PDD—premenstrual dysphoric disorder—a more serious condition than PMS, that causes anxiety, tension, and persistent anger, to name a few. (more…)

A rising number of Pradaxa bleeding cases have prompted European regulators to warn that Pradaxa prescriptions should be written with caution. The new stroke prevention pill has been linked to 256 cases of deadly bleeding.

The maker of Pradaxa, Boehringer Ingelheim recently confirmed that about 260
Pradaxa deaths, worldwide, were linked to the blood thinner. The current figure is about five times greater than what Boehringer Ingelheim initially reported this month when it said 50 fatal deaths from Pradaxa bleeding had been totaled.
Pradaxa safety concerns have been on the rise following the deaths, said Reuters. (more…)

Anti-stroke medication, Pradaxa, has been linked to deaths according to Pradaxa manufacturer Boehringer Ingelheim GmbH. Boehringer Ingelheim GmbH confirmed that the deaths occurred in German patients taking Pradaxa, said Die Zeit, citing Boehringer spokesman, Reinhard Malin.

The blood thinner, Pradaxa is approved to prevent strokes in people with atrial fibrillation and is one of a number of new anti-blood-clotting pills expected to replace the older generation warfarin. Pradaxa is excreted through the kidneys, so impaired kidney function can cause unusually high levels of the drug to remain in the body, which can lead to very significant bleeding risks. (more…)

The maker of Pradaxa, Boehringer Ingelheim, just announced that in Europe, patients need kidney checks before taking the anti-clotting medication. The announcement is not doing much for Pradaxa’s safety profile.

According to Reuters, Pradaxa, a thrombin inhibitor, is the first of a new class of anti-clotting medications on which high hopes were placed. Unlisted Boehringer, the second-largest drugmaker in Germany, agreed with the European Medicines Agency’s (EMA) that updated information be provided to European healthcare professionals, Reuters noted. (more…)

The 2008 Baxter heparin disaster made headlines for months over contaminated ingredients that led to massive recalls and resulted in serious, some fatal, allergic reactions worldwide.

Now, three years later, two companies in China that had supplied the deadly ingredients to Baxter International Inc. are still sending their product to the United States, according to Republican lawmakers, said Bloomberg Businessweek. (more…)

Sepsis drug Xigris (Drotrecogin alfa) has been withdrawn from the market by drug maker, Eli Lilly and Company; this, following poor outcomes in a recent clinical trial. According to Reuters, Xigris did not improve survival in the PROWESS-SHOCK trial.

NewsInferno previously wrote that Eli Lilly’s intravenous sepsis treatment was the subject of a U.S. Food and Drug Administration (FDA) safety review prompted by a prior study that revealed Xigris increased risks for dangerous internal bleeding when used by patients with a recent hemorrhage history. Similar to a natural protein produced in the body, Xigris decreases inflammation and blood clot formation in blood vessels and increases blood clot breakdown. (more…)

Diethylstilbestrol—commonly known as DES—is a synthetic estrogen developed to supplement a woman’s natural estrogen production, for instance to prevent miscarriages and premature births. DES was first prescribed in 1938 and was widely used from the 1940s through the 1960s. Among other dangerous side effects, the drug has rendered DES Daughters—women whose mothers took DES—susceptible to a rare uterine cancer.

A recent New England Journal of Medicine report, dated October 6, has sparked renewed interest into the matter and is bringing attention to the long-term complications faced by DES Daughters, said NewsWise. (more…)