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Testosterone Lawsuit Update: FDA Advisory Committee Decides Further Study of Cardiovascular Risks Required

Bloomberg News reports that the members of a Food and Drug Administration (FDA) Advisory Committee unanimously agreed this week that manufacturers of testosterone drugs should further study the potential cardiovascular health risks of testosterone products and who should take these drugs. According to the FDA, the Advisory Committee Meeting was held on September 17, 2014 […]

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New Canadian Study Reveals Increased Risk of Permanent Nerve Damage with Use of Fluoroquinolones Antibiotics

The Vancouver Sun reports that an Ontario group of researchers at the University of British Columbia found a link between use of fluoroquinolones and peripheral neuropathy. In particular, the researchers found that men using these particular antibiotics, especially first-time users, were twice as likely to experience peripheral neuropathy as men who were not using fluoroquinolones. […]

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Schlichter, Bogard & Denton, LLP News: Partner Kristine Kraft Appointed to the Plaintiffs’ Steering Committee in Testosterone Therapy MDL 2545

Kristine Kraft, a partner at Schlichter, Bogard & Denton, LLP, has been appointed to the Plaintiffs’ Steering Committee in the Low-T Multidistrict Litigation (MDL 2545) pending in the Northern District of Illinois (Case Management Order No. 4, In Re: Testosterone Therapy Products Liability Litigation, Case No. 1:14-cv-1748, MDL No. 2545, N.D. Ill.). The Honorable Matthew […]

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BMJ Investigation Shows Boehringer Ingelheim Withheld Critical Safety Information on Pradaxa®

Roger Denton of Schlichter, Bogard & Denton, LLP reports that the manufacturers of the blood thinning medication Pradaxa® withheld from regulators critical evidence on how monitoring drug plasma levels could have improved the drug’s safety, according to a recent BMJ Investigation. A recent article published in the British Medical Journal (BMJ) on July 23, 2014 […]

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FDA Issues New Safety Announcement: Next-Day Impairment with Sleep Aid Lunesta®

On May 15, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement warning that the insomnia drug Lunesta® (eszopiclone) can cause next-day impairment that can last more than 11 hours after receiving an evening dose. A recent study of Lunesta® found that the previously recommended dose of 3mg can cause impairment to driving […]

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New Study Reports Potential Link between Viagra and Deadly Skin Cancer

A recent article published by JAMA Internal Medicine in April 2014 evaluated the association between sildenafil use and the risk of incident melanoma among men in the United States. The study concluded that “[s]ildenafil use may be associated with an increased risk of developing melanoma.” In particular, the researchers found that men who took sildenafil […]

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Fosamax® MDL Update: Judge Denies Merck’s Request to Require Plaintiffs to Substantiate Injuries

Law 360 reports that Judge John Keenan of the Southern District of New York has denied Defendants’ request mandating hundreds of alleged Fosamax® victims to substantiate their injuries. Judge Keenan, who serves as the presiding judge in the Multidistrict Litigation In Re: Fosamax® Products Liability Litigation (MDL 1789), said the “process would devolve into a […]

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Public Citizen Requests that the FDA Require a Black Box Warning for Plavix®

According to the Associated Press, the advocacy group Public Citizen filed a petition with the United States Food and Drug Administration (FDA) last week requesting that a Black Box Warning be added to the Plavix® product label to alert people to the risks of major bleeding when the drug is used by patients who have […]

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FDA Warns Public that “Fat Zero” Contains Hidden and Dangerous Drug

The Food and Drug Administration (FDA) has issued a Public Notification advising consumers not to purchase or take “Fat Zero”, a weight loss product sold in various retail stores and websites. The FDA provides that “FDA laboratory analysis confirmed that Fat Zero contains sibutramine. Sibutramine is a controlled substance that was removed from the market […]

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FDA Warns of Safety Concerns Associated with Nizoral® Antifungal Medication

On July 26, 2013, the Food and Drug Administration (FDA) issued a drug safety communication that use of the antifungal medication, Nizoral®, may cause fatal liver injury and adrenal gland problems, and may interact dangerously with other drugs. In conjunction with this drug safety communication, the FDA has approved label changes for Nizoral® involving recommendations […]

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