The judge overseeing the Yaz and Yasmin multidistrict litigation has been asked to allow evidence concerning a U.S. Food and Drug Administration (FDA) conflict of interest. Women suing Yaz, Yasmin maker, Bayer, for injuries they alleged to have suffered from the controversial birth control pills, have urged U.S. District Judge, David Herndon, to review evidence pointing to conflicts of interest at the agency, wrote The Madison Record.

The Plaintiffs’ Steering Committee has opposed a January 17 motion by the defense to exclude former FDA commissioner, David Kessler’s, opinions about the current FDA. Kessler, an expert witness for the plaintiffs, noted panel conflicts in an expert opinion in which he stated, after reviewing internal Bayer documents, that Bayer wrongfully withheld safety information from the agency, said Pharmalot. (more…)

A new, 10-state study spanning from 1997 links asthma drugs to three serious birth defects. The study appears in the January 16th online issue of the journal, Pediatrics.

The study authors wrote that babies of women who took asthma drugs when pregnant suffered increased risks for isolated esophageal atresia (closed area of the esophagus), isolated anorectal atresia (closed area of the rectum and/or anus), and omphalocele (out-pouching of the intestines), said The Examiner. The risk was specifically seen in pregnant woman who took asthma medications in the month prior to becoming pregnant or in the first three months of being pregnant. (more…)

Antidepressant use during pregnancy has been linked to lung problems in newborn babies, according to an emerging study.

The study found that expectant mothers taking widely prescribed antidepressants are at a two-fold increased risk for giving birth to babies diagnosed with a rare, but serious, lung disorder, said WebMD. Specifically, selective serotonin reuptake inhibitor (SSRI) antidepressants such as Celexa, Lexapro, Paxil, Prozac, and Zoloft were linked to persistent pulmonary hypertension in newborns (PPHN) in this study. (more…)

Following a year of recalls, Johnson & Johnson has implemented yet another. This time, Johnson & Johnson is recalling a massive 12 million bottles of Motrin. It seems the defective Motrin dissolves too slowly.

Johnson & Johnson’s McNeil Consumer Healthcare unit wrote in a statement on its website that product testing indicated that some Motrin caplets might not dissolve as soon as they are supposed to when the mediation nears its expiration date, said Bloomberg Businessweek. Customers do not have to return the painkillers; however, there may be what McNeil described as “a delay in relief” after taking Motrin, spokeswoman Bonnie Jacobs told Businessweek. (more…)

Lawsuits are mounting over Proscar and Propecia, and claims have been filed federally and at the state level. Plaintiffs allege that the drugs are dangerous and that drug maker Merck, knew or should have been aware, but neglected to warn, of side effects that include erectile dysfunction, infertility, depression, and suicide.

Proscar and Propecia, which are known generically as finasteride belong to a class of drugs called 5-alpha reductase inhibitors, or 5-ARIs. Proscar is used to treat enlarged prostate, while Propecia is used to treat male pattern baldness. (more…)

Heart drug, Multaq, is subject to new restrictions, according to federal health officials. New safety warnings are being mandated following a study by drug maker, Sanofi, that linked Multaq (dronedarone) to serious cardiac events as well as a review of clinical trial data by the U.S. Food & Drug Administration (FDA) that revealed a link between Multaq and increased heart attack, stroke, and death in some patients.

Multaq is approved to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted.

The new boxed warning stresses study results that revealed that Multaq doubled risks for cardiac complications in patients with permanent AF, said The Associated Press (AP). Permanent AF is a condition in which the heart’s chambers pump out of rhythm. The new label also emphasizes that Multaq is only approved for short-term AF and AFL, a related condition, said the AP.

The FDA announced that it completed a safety review of Multaq that revealed an increased risk of serious cardiovascular events, including death, when used by patients in permanent AF; the FDA’s review was based on data from the PALLAS and ATHENA clinical trials. The revised Sanofi label, which was written collaboratively by the FDA and Sanofi and has been revised with the following changes and recommendations:

• Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
• Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
• Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
• Patients prescribed Multaq should receive appropriate antithrombotic therapy.

The FDA initiated its Multaq safety review in January, updating the drug’s label to include “liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Multaq.” In July, the FDA expanding this warning to include heart side effects, following PALLAS study results that revealed that patients taking Multaq for permanent AF were at a two-fold risk of death and increased risks for heart attack and stroke.. PALLAS was ceased over the summer after Multaq patients experienced higher-than-anticipated adverse cardiac events.

Yesterday’s FDA Drug Safety Communication indicated that 25 Multaq patients died during PALLAS, as opposed to 13 in the placebo group. Of those, 14 Multaq patients experienced sudden death or death from arrhythmia, versus 4 in the placebo group. In the Multaq group, 23 patients suffered stroke and 43 were hospitalized with heart failure, versus 10 and 24, respectively, from the placebo group. The FDA also reviewed ATHENA data, which was used to grant Multaq’s approval for temporary AF. The Safety Communication indicated that Multaq patients did not suffer increased cardiovascular death, stroke, or heart failure risks and, because of this, the FDA maintains that Multaq provides a benefit for patients with non-permanent AF.

The SSRI link to PPHN remains unclear, according to the U.S. Food & Drug Administration (FDA), which just issued an update to the public concerning the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by expectant mothers. At issue is the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN).

The FDA’s initial Public Health Advisory issued in July 2006 on this potential risk was based on one published study; however, since, there have been conflicting findings from new studies evaluating the risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN. At this time, the agency is advising health care professionals not to alter their current clinical practice of treating depression during pregnancy. Healthcare professionals and patients should report any adverse events involving SSRIs to the FDA MedWatch Program, the agency said. (more…)

Pancreatitis has doctors concerned with the medications Byetta and Januvia, drugs used in the treatment of Type 2 diabetes. A recent syndicated, impact-assessment study has raised some issues regarding the medications and has doctors wary of prescribing the drugs. The study, conducted by dtw Marketing Research Group, Inc., was published in the American Gastroenterology Association Journal, said PharmaLive.

As NewsInferno wrote, the controversy was sparked by research that indicated that medications like Byetta and Januvia might raise risks for pancreatic cancer and pancreatitis. The makers of the drugs continue to maintain the medications are safe. (more…)

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.