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Mislabeling of Non-24 Sleep Disorder Drug May Encourage Off-Label Use, Advocacy Group Warns

Mislabeling May Encourage Off-Label Use

Mislabeling May Encourage Off-Label Use

The drug Hetlioz was approved last year for the treatment of a disorder that affects blind people known as “non-24 sleep-wake disorder.” One consumer advocacy group says the U.S. Food and Drug Administration (FDA) made a mistake on the drug’s label and inadvertently widened the market for the drug.

Non-24 is a rare condition that throws off the internal body clock and causes sleeping problems. The disorder only affects people who are completely blind. The FDA became aware of the mistake last year, but instead of revising the Hetlioz product labeling, the agency issued a second approval letter. The second letter stated that the first letter contained an error about the approved use of the drug, and went on to change the description of the approved use to match the incorrect product labeling, The Wall Street Journal (WSJ) reported. More Mislabeling of Non-24 Sleep Disorder Drug May Encourage Off-Label Use, Advocacy Group Warns

Researchers Found Numerous Cases of Congenital Abnormalities Possibly Caused by Zoloft, According to a 1998 Report

Researchers Found Congenital Abnormalities Caused by Zoloft

Researchers Found Congenital Abnormalities Caused by Zoloft

A 1998 Pfizer Inc. report shows a company scientist warned the drug maker about a potential link between its antidepressant drug Zoloft and birth defects and recommended changes to the medication’s safety warning.

Pfizer has consistently rejected implications that Zoloft can cause birth defects when taken by expectant mothers, even as the company faces more than 1,000 lawsuits brought over the potential link. Pfizer said Monday the document was taken out of context by lawyers representing plaintiffs who allege the company knew Zoloft caused newborn abnormalities, according to Bloomberg. More Researchers Found Numerous Cases of Congenital Abnormalities Possibly Caused by Zoloft, According to a 1998 Report

Federal Health Officials Warn of the Risks Associated with Soft Tissue Fillers

Federal Health Officials Warn of the Risks in Soft Tissue Fillers

Federal Health Officials Warn of the Risks in Soft Tissue Fillers

The U.S. Food and Drug Administration (FDA) issued a Safety Communication on May 28 warning health care providers that “unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects.”

The communication is intended for dermatologists, plastic surgeons, cosmetic surgeons, dentists, and other medical providers who treat patients using soft tissue fillers; and other health care providers who may treat patients following unintentional injection of soft tissue filler into blood vessels, such as ophthalmologists, neurologists, and neurosurgeons, according to the Safety Communication posted on the FDA website. More Federal Health Officials Warn of the Risks Associated with Soft Tissue Fillers

Women Who Use Tylenol for Prolonged Periods May Have Baby Boys With Fertility Problems

Tylenol Use in Pregnancy Cause Baby Boys Fertility Problems

Tylenol Use in Pregnancy Cause Baby Boys Fertility Problems

Prolonged use of Tylenol during pregnancy could negatively impact the future fertility of baby boys, a new study shows.

According to researchers at the U.K.’s University of Edinburgh, acetaminophen – the active ingredient in Tylenol – could reduce testosterone production in baby boys. Tylenol has long been considered a safe drug for pregnant women to take for fever and pain, but the scientists say lower exposure to testosterone in the womb has been linked to a greater risk of male infertility, undescended testicles and testicular cancer, Toronto Sun reported. More Women Who Use Tylenol for Prolonged Periods May Have Baby Boys With Fertility Problems

Researchers Find that Excessive Testosterone and an Unhealthy Diet May Contribute to an Enlarged Prostate

Testosterone/Unhealthy Diet Contribute to Enlarged Prostate

Testosterone/Unhealthy Diet Contribute to Enlarged Prostate

Approximately 90 percent of men age 80 and older experience a condition called benign prostatic hyperplasia (BPH), also known as an enlarged prostate. About 40 percent of men require some sort of treatment. According to a new study, too much testosterone may be a cause of BPH.

Despite how common BPH is – and the estimated tens of billions of dollars in medical expenses, lost wages and other costs that go with it – the exact cause of the condition have not been positively identified, but researchers at the University of California (UC) Santa Barbara believe excess testosterone may be the culprit, according to Medical Xpress. More Researchers Find that Excessive Testosterone and an Unhealthy Diet May Contribute to an Enlarged Prostate

The Mismarketing of Drugs Results in Excess Side Effects, Deaths and Billions of Dollars in Costs

The Mismarketing of Drugs Results in Excess Side Effects

The Mismarketing of Drugs Results in Excess Side Effects

Patent monopolies encourage rent-seeking behavior, like mismarketing, according to a report by the Center for Economic and Policy Research (CEPR).

Drugs are frequently mismarketed when manufacturers seek U.S. Food and Drug Administration (FDA) approval for one of their products and then promote the drug for unapproved uses once it has reached the market, according to the report, Patent Monopolies and the Costs of Mismarketing Drugs. Companies also mismarket a drug when they deliberately conceal data showing the product is less effective than touted, or potentially dangerous. There are “major costs associated with the enormous asymmetry between the knowledge available to drug companies and the knowledge available to patients and their doctors,” the authors of the paper wrote. More The Mismarketing of Drugs Results in Excess Side Effects, Deaths and Billions of Dollars in Costs

Takeda Announces it will Pay $2.4 Billion to Settle Thousands of Actos Lawsuits

Takeda Announces, will Pay $2.4B to Settle Actos Lawsuits

Takeda Announces, will Pay $2.4B to Settle Actos Lawsuits

Takeda Pharmaceutical announced Tuesday that will pay $2.4 billion to settle thousands of lawsuits filed on behalf of patients and their family members who alleged the company’s diabetes drug Actos caused them to develop bladder cancer.

The Japanese drug maker said the settlement would resolve most of the product-liability suits related to Actos. The company said it would take a $2.7 billion charge against earnings to cover the settlement and costs for defending the remaining cases. There are approximately 9,000 bladder cancer claims pending against Takeda relating to Actos. Plaintiffs’ lawyers had accused the company of concealing the cancer risk associated with the drug, according to The New York Times (The Times). More Takeda Announces it will Pay $2.4 Billion to Settle Thousands of Actos Lawsuits

Scientists Link the Statin Drugs Lipitor and Zocor to an Increased Risk of Type 2 Diabetes

 

Scientists Link the Statin Drugs Lipitor and Zocor

Scientists Link the Statin Drugs Lipitor and Zocor

Scientists have known as far back as 2013 that a link exists between statin drugs and Type 2 diabetes, but a new study has found that the cholesterol-lowering drugs Zocor and Lipitor, in particular, greatly increase the risk for Type 2 diabetes.

For the study, Professor Markku Laakso of the Institute of Clinical Medicine at the University of Eastern Finland and Kuopio University Hospital in Finland and his team of colleagues analyzed the effects of statin use on 8,749 non-diabetic Caucasian men ages 45-73 years old that were part of the Finland-based Metabolic Syndrome in Men (METSIM) study, according to Medical News Today (MNT). More Scientists Link the Statin Drugs Lipitor and Zocor to an Increased Risk of Type 2 Diabetes

Public Health Experts are Frustrated by Health Regulators’ Reluctance to Ban Adulterated Supplements

Vitamin shops across the nation are carrying weight-loss and workout supplements containing a powerful amphetamine-like stimulant known as BMPEA.

In 2013, the U.S. Food and Drug Administration (FDA) documented nine supplements that contained BMPEA, but never made the names of those products public. So far, the agency has not recalled BMPEA-containing supplements, as it has done with other “adulterated” products. The chemical itself has never been sold as a food or supplement, so any product containing BMPEA is considered adulterated, according to The New York Times (The Times). More Public Health Experts are Frustrated by Health Regulators’ Reluctance to Ban Adulterated Supplements

May 1 Deadline set to Submit Mirena IUD Cases for Consideration in the Second Deposition Pool

A May 1, 2015 deadline has been set for Bayer Inc. and plaintiffs involved in the Mirena intrauterine device (IUD) litigation to select seven cases to potentially be included in the Second Deposition Pool.

Plaintiffs who wish to have their cases considered for potential inclusion in the Second Deposition Pool must have the Core Criteria in the Plaintiff Fact Sheet completed no later than May 1, 2015, according to a March 17 court order. The Lead Counsel for the Plaintiffs’ Steering Committee (PSC) and Lead Counsel for the Defendants must submit their selections to the court by email by 4:00 p.m. Eastern Standard Time on July 2, 2015. The court order states that these cases should not have unique or idiosyncratic circumstances.

Case-specific discovery in the Second Deposition Pool will be completed by February 18, 2016. It will be possible to extend this deadline per a specific agreement, or if good cause can be shown. Both parties must submit four of the Second Deposition Pool cases for trial via email by 4:00 p.m. Eastern Standard Time on March 4, 2016. Each parties may submit two vetoes of the other party’s choice no later than 4:00 p.m. Eastern Standard Time on March 11, 2016. All parties must conduct depositions of all experts for the agreed upon cases between June 15, 2016 and September 15, 2016.

The court will set brief schedules for dispositive motions and Kemp motions as well as a trial schedule for the Second Deposition Pool Trial cases by August 15, 2016. Raymond C. Silverman, of Parker Waichman LLP, has been appointed Co-Lead Counsel in the litigation.

The Mirena IUD device is approved as an intrauterine contraceptive device and as a treatment for heavy menstrual bleeding in women who gave birth. Many women allege that the device caused them serious side effects including group A streptococcal sepsis, pelvic inflammatory disease (PID), perforation of and embedment in the device in the uterine walls or cervix, headaches, ovarian cysts, ectopic pregnancy and vaginitis. The IUDs have also been reported to migrate after insertion and become undetectable.