Bayer will discontinue the marketing and sales of the sterilization device Essure in all countries outside of the United States, the company announced on Monday. 

While a number of reports have linked the Essure implants to health problems, including chronic pain and bleeding, Bayer said it’s pulling the device from non-U.S. markets for commercial reasons.

“We would like to reassure the Essure patients and their accompanying healthcare professionals that this decision is made for commercial reasons and that it is not related to a safety or product quality issue,” the company said in a statement on its website.

Essure is a permanent birth control procedure that involves two nickel-titanium coils placed inside the fallopian tubes to spur the growth of scar tissue that eventually blocks the tubes to prevent pregnancy.

In 2016, the U.S. Food and Drug Administration added a boxed warning – its most serious type – to alert doctors and patients to problems reported with the implant.

While the label had already come with a warning of pelvic pain and bleeding immediately after the procedure, many women said the problems persisted and were so severe they needed surgery to remove the device.

Other women reported the implant had fallen out of position and embedded itself elsewhere in the body.

A Facebook group called Essure Problems where members share their stories and complaints with the device currently has more than 34,000 members.

In its statement, Bayer affirms that “Essure’s positive benefit-risk profile remains unchanged.”

“Essure’s safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience,” the statement reads.

The company cites “an environment unfavorable to its prescription” as the cause of “a continuous decline in demand” for the last several months.

According to the FDA’s website, the agency continues to monitor the safety of Essure and believes that “the benefits of the device outweigh its risks.”

In an emailed statement, the agency said it is aware that Bayer is no longer marketing Essure in any countries except for the U.S. 

“The FDA has taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device,” the agency said.

MONDAY, July 3, 2017 — Popular heartburn medications like Nexium, Prilosec or Prevacid may increase your risk of early death when taken for extended periods, a new study suggests.

Further, the longer you take these drugs, known as proton pump inhibitors (PPIs), the greater your risk of early death, said senior researcher Dr. Ziyad Al-Aly. He is a kidney specialist and assistant professor of medicine with the Washington University School of Medicine, in St. Louis.

“There was a relationship between duration of use and risk of death,” Al-Aly said. “More prolonged use was associated with even higher risk.”

That said, Al-Aly pointed out that some patients really do need to take PPIs to deal with medical issues, even long-term.

“Proton pump inhibitors actually save lives,” Al-Aly said. “We don’t want to leave people with a scary message. If you need this drug and you’re under guidance of a doctor, you should continue to take your medication until otherwise advised.”

The study found that people taking PPIs for a year or more had a 51 percent increased risk of premature death, compared with 31 percent for people on the drugs for six months to a year, and 17 percent for three- to six-month users.

Short-term use of PPIs — up to 90 days — did not appear to affect death risk, the findings showed.

Proton pump inhibitors work by blocking the enzyme system that produces stomach acid. PPIs have become one of the most commonly used classes of drugs in the United States, with 15 million monthly prescriptions in 2015 for Nexium alone, the researchers said.

However, concerns about the drugs’ safety have been growing in recent years, as studies have linked PPIs to kidney disease, heart disease, pneumonia, bone fractures and dementia.

To take a broad look at PPIs and whether they increase a person’s chances of premature death, Al-Aly and his colleagues compared the medical records of nearly 276,000 users of PPIs against those of about 73,000 people who took another class of heartburn drug called H2 blockers.

Overall, PPI users have a 25 percent increased risk of premature death compared with people taking H2 blockers (such as Pepcid or Zantac), the investigators found.

The researchers calculated that for every 500 people taking PPIs for a year, there is one extra death that would not have occurred otherwise, Al-Aly said.

One doctor said the results should be heeded.

“This finding is certainly cause for concern and something that should be considered as doctors continue to prescribe PPIs at a high rate and often fail to discontinue these drugs in a timely fashion,” said Dr. Louis Cohen. He is an assistant professor of gastroenterology with the Icahn School of Medicine at Mount Sinai, in New York City.

At the same time, Cohen noted that people taking PPIs also tend to have many other health problems, and these might influence their risk of death as well.

No one is sure why PPIs might cause all these health problems or increase risk of early death, Al-Aly said. It is possible the drugs might cause cellular or genetic damage.

Even though this study could not prove a direct cause-and-effect relationship, Al-Aly noted that the increased risk with longer duration adds weight to concerns over the drugs’ safety.

“Why would prolonged use be associated with higher risk if there were no real relationship between exposure and untoward outcomes?” he said.

Recommended treatment regimens for most PPIs are relatively short, the researchers said. For example, people with ulcers are advised to take the drugs for only two to eight weeks.

But since the drugs are available over-the-counter, many people take PPIs for months or years to manage heartburn or acid reflux, Al-Aly said.

“If people find themselves taking proton pump inhibitors for an extended period of time with no valid need for doing so, or for symptoms that can be managed in other ways, that’s when there’s far more risk than any potential benefit,” Al-Aly said.

Cohen said that “there is little question that the short-term use of PPIs for many conditions can be beneficial to patients.”

And because “studies to demonstrate causal relationships between PPIs and death are not likely,” Cohen added, “the challenge to physicians should remain to use medications judiciously and continue to assess the benefit of a medication to a patient over time.”

The first time Jolene Rudell fainted, she assumed that the stress of being in medical school had gotten to her. Then, two weeks later, she lost consciousness again.

Blood tests showed Ms. Rudell’s red blood cell count and iron level were dangerously low. But she is a hearty eater (and a carnivore), and her physician pointed to another possible culprit: a popular drug used by millions of Americans like Ms. Rudell to prevent gastroesophageal acid reflux, or severe heartburn.

Long-term use of the drugs, called proton pump inhibitors, or P.P.I.’s, can make it difficult to absorb some nutrients. Ms. Rudell, 33, has been taking these medications on and off for nearly a decade. Her doctor treated her anemia with high doses of iron, and recommended she try to manage without a P.P.I., but that’s been difficult, she said. “I’m hoping I’ll get off the P.P.I. after I complete my residency training,” she said, “but that’s still several years away.”

As many as four in 10 Americans have symptoms of gastroesophageal reflux disease, or GERD, and many depend on P.P.I.’s like Prilosec, Prevacid and Nexium to reduce stomach acid. These are the third highest-selling class of drugs in the United States, after antipsychotics and statins, with more than 100 million prescriptions and $13.9 billion in sales in 2010, in addition to over-the-counter sales.

But in recent years, the Food and Drug Administration has issued numerous warnings about P.P.I.’s, saying long-term use and high doses have been associated with an increased risk of bone fractures and infection with a bacterium called Clostridium difficile that can be especially dangerous to elderly patients. In a recent paper, experts recommended that older adults use the drugs only “for the shortest duration possible.”

Studies have shown long-term P.P.I. use may reduce the absorption of important nutrients, vitamins and minerals, including magnesium, calcium and vitamin B12, and might reduce the effectiveness of other medications, with the F.D.A. warning that taking Prilosec together with the anticlotting agent clopidogrel (Plavix) can weaken the protective effect (of clopidogrel) for heart patients.

Other research has found that people taking P.P.I.’s are at increased risk of developing pneumonia; one study even linked use of the drug to weight gain.

Drug company officials dismiss such reports, saying that they do not prove the P.P.I.’s are the cause of the problems and that many P.P.I. users are older adults who are susceptible to infections and more likely to sustain fractures and have nutritional deficits.

But while using the drugs for short periods may not be problematic, they tend to breed dependency, experts say, leading patients to take them for far longer than the recommended 8 to 12 weeks; some stay on them for life. Many hospitals have been starting patients on P.P.I.’s as a matter of routine, to prevent stress ulcers, then discharging them with instructions to continue the medication at home. Dr. Charlie Baum, head of U.S. Medical Affairs for Takeda Pharmaceuticals North America Inc., said its P.P.I. Dexilant is safe when used according to the prescribed indication of up to six months for maintenance, though many physicians prescribe it for longer.

“Studies have shown that once you’re on them, it’s hard to stop taking them,” said Dr. Shoshana J. Herzig of Beth Israel Deaconess Medical Center in Boston. “It’s almost like an addiction.”

P.P.I.’s work by blocking the production of acid in the stomach, but the body reacts by overcompensating and, she said, “revving up production” of acid-making cells. “You get excess growth of those cells in the stomach, so when you unblock production, you have more of the acid-making machinery,” she said.

Moreover, proton pump inhibitors have not been the wonder drugs that experts had hoped for. More widespread treatment of GERD has not reduced the incidence of esophageal cancers. Squamous cell carcinoma, which is associated with smoking, has declined, but esophageal adenocarcinomas, which are associated with GERD, have increased 350 percent since 1970.

“When people take P.P.I.’s, they haven’t cured the problem of reflux,” said Dr. Joseph Stubbs, an internist in Albany, Ga., and a former president of the American College of Physicians. “They’ve just controlled the symptoms.”

And P.P.I.’s provide a way for people to avoid making difficult lifestyle changes, like losing weight or cutting out the foods that cause heartburn, he said. “People have found, ‘I can keep eating what I want to eat, and take this and I’m doing fine,’ ” he said. “We’re starting to see that if you do that, you can run into some risky side effects.”

Many patients may be on the drugs for no good medical reason, at huge cost to the health care system, said Dr. Joel J. Heidelbaugh, a family medicine doctor in Ann Arbor, Mich. When he reviewed medical records of almost 1,000 patients on P.P.I.’s at an outpatient Veterans Affairs clinic in Ann Arbor, he found that only one-third had a diagnosis that justified the drugs. The others seemed to have been given the medications “just in case.”

“We put people on P.P.I.’s, and we ignore the fact that we were designed to have acid in our stomach,” said Dr. Greg Plotnikoff, a physician who specializes in integrative therapy at the Penny George Institute for Health and Healing in Minneapolis.

Stomach acid is needed to break down food and absorb nutrients, he said, as well as for proper functioning of the gallbladder and pancreas. Long-term of use of P.P.I.’s may interfere with these processes, he noted. And suppression of stomach acid, which kills bacteria and other microbes, may make people more susceptible to infections, like C. difficile.

Taking P.P.I.’s, Dr. Plotnikoff said, “changes the ecology of the gut and actually allows overgrowth of some things that normally would be kept under control.”

Stomach acid also stimulates coughing, which helps clear the lungs. Some experts think this is why some patients, especially those who are frail and elderly, face an increased risk of pneumonia if they take P.P.I.’s.

But many leading gastroenterologists are convinced that the benefits of the drugs outweigh their risks. They say the drugs prevent serious complications of GERD, like esophageal and stomach ulcers and peptic strictures, which occur when inflammations causes the lower end of the esophagus to narrow.

The studies that detected higher risks among patients on P.P.I.’s “are statistical analyses of very large patient populations. But how does that relate to you, as one person taking the drug?” said Dr. Donald O. Castell, director of esophageal disorders at the Medical University of South Carolina and an author of the American College of Gastroenterology’s practice guidelines for GERD, who has financial relationships with drug companies that make P.P.I.’s. He added, “You don’t want to throw the baby out with the bathwater.”

Most physicians think that GERD is a side effect of the obesityepidemic, and that lifestyle changes could ameliorate heartburn for many.

“If we took 100 people with reflux and got them to rigidly follow the lifestyle recommendations, 90 wouldn’t need any medication,” Dr. Castell said. “But good luck getting them to do that.”

A Pennsylvania man has joined the growing litigation involving proton pump inhibitors, filing a federal lawsuit after he allegedly developed chronic kidney disease due to his use of Nexium.

Nexium Kidney Disease Allegations

In his November 21^st filing with the U.S. District Court, District of New Jersey, James Marzec claims that AstraZeneca failed to warn patients and doctors that Nexium could harm the kidneys, leading to life-long and permanent injuries. (Case No. 2:17-cv-11922)

According to his complaint, Marzec was first prescribed Nexium in 2012, and continued to use it consistently through 2013.

“As a result of using Defendants’ Nexium, Plaintiff suffers from stage three chronic kidney disease,” the lawsuit states. “Plaintiff sustained severe and permanent personal injuries, pain, suffering, economic loss, and emotional distress.”

Marzec’s lawsuit further asserts that he never would have used Nexium had he or his doctor been warned of its potential to cause chronic kidney disease and other serious renal side effects.

“To this day, Defendants deny that Nexium can cause CKD and actively conceal their knowledge relating to the true risks of CKD and other kidney injury related to the use of Nexium,” the complaint charges.

“Defendants, through their affirmative misrepresentations and omissions, actively concealed from Plaintiff and Plaintiff’s prescribing physicians the true and significant risks associated with the use of Nexium.”

Nexium and Proton Pump Inhibitors

In 2013, more than 15 million Americans turned to prescription proton pump inhibitors to relieve symptoms associated with GERD and other peptic disorders.  Millions of others have taken over-the-counter versions.

By some estimates, up to 70% of proton pump inhibitor prescriptions lack an appropriate indication. Many patients also take the drugs for far longer than recommended, often not realizing that they are indicated for only short-term treatment.

Nexium is one of the most well-known and popular drugs in the proton pump inhibitor class. It is AstraZeneca’s largest-selling drug, as well as the third largest-selling globally.

In 2005, AstraZeneca’s sales of Nexium exceeded $5.7 billion. In 2008, its sales exceeded $5.2 billion.

Proton Pump Inhibitor Lawsuits

Marzec’s Nexium lawsuit is just one of the most recent cases to be filed in the District of New Jersey, where all federally-filed kidney injury claims involving proton pump inhibitors have been centralized for coordinated pretrial proceedings. As of November 15^th, at least 315 lawsuits were pending in the New Jersey against the manufacturers of Nexium, Prilosec, Prevacid, Protonix, and Dexilant.

In recent years, a growing number of studies have suggested that long-term proton pump inhibitor treatment can harm the kidneys.

In 2014, for example, the U.S. Food & Drug Administration (FDA) ordered proton pump inhibitor manufacturers to add mention of acute interstitial nephritis to the drugs’ labels. This condition is marked by a sudden inflammation of the kidney tubules, that if not recognized and treated immediately, can progress to chronic kidney disease and even kidney failure.

In April 2016, the Journal of the American Society of Nephrology published research tying long-term proton pump inhibitor use to a 96% increase in the risk for kidney failure and a 28% higher risk for chronic kidney disease compared another class of heartburn medications called H2-blockers.

Another study published in the January 2016 issue JAMA Internal Medicine suggested that long-term proton pump inhibitor treatment increased the risk of chronic kidney disease by as much as 50%.

You’ve probably used it, or had it sprinkled on you at some time in your life. It’s processed from a soft mineral compound of magnesium silicate, and is called talcum powder or just talc.

Talcum dusting powder is commonly used to reduce rashes and diaper irritation in babies and infants. But this practice is dangerous. It can result in the inhalation of significant amounts of powder, causing acute or chronic lung irritation, known as talcosis. However, this risk is readily avoidable as cornstarch powder is a safe and reliable alternative.

Manufactured by Johnson & Johnson, and widely distributed by Osco and Walgreens, besides other drug stores, women have been persuaded by advertisements to dust themselves with talcum powder to mask alleged genital odors. Not surprisingly, the powder has become a symbol of freshness and cleanliness for over five decades. 

The first warning of the dangers of genital talc came in a 1971 report on the identification of talc particles in ovarian cancers, a finding sharply contested by Dr. G.Y. Hildick-Smith, Johnson & Johnson’s medical director. However, a subsequent publication in the prestigious The Lancet warned that “The potentially harmful effects of talc . . . in the ovary . . . should not be ignored.”

This warning was confirmed in a 1992 publication in Obstetrics & Gynecology which reported that a woman’s frequent talc use on her genitals increased her risk of ovarian cancer by threefold. The talc in question was simple brand or generic ‘baby powder.’

Subsequent to the 1992 report, at least a dozen other major science articles documenting the link between talc and ovarian cancer appeared in leading medical journals such as Cancer, The Lancet, and Oncology. The capstone of this research case against talc came in 2003 when the journal Anticancer Research published a ‘meta-analysis,’ or large scale review, of 16 previous published studies involving 11,933 women; a 33 percent increased risk of ovarian cancer was confirmed.

Not surprisingly, the mortality of ovarian cancer in women 65 years of age and older has escalated sharply, especially in black women who have a higher rate of talc use than other races.

Nearly 16,000 women in the U.S. die from ovarian cancer each year, which means it is the fourth most common fatal cancer in women. By some estimates, one out of five women regularly applies talc to her genitals. This usage occurs either through direct application, or as a result of tampons, sanitary pads and diaphragms that have been dusted with talc.

More acknowledgment of talc’s dangers emerged even from the cosmetics industry. The president of the industry’s Cosmetic Toiletry and Fragrance Association, Edward Kavanaugh, conceded in 2002 that talc is toxic and “can reach the human ovaries.” Yet, inexplicably, talc manufacturers failed to warn women that the product could be dangerous to their health.

Nor has the Food and Drug Administration (FDA) even shown casual concern about the dangers of talc. The closest admission to this effect came in 1993 when the Acting Associate Commissioner for Legislative Affairs of the Department of Health and Human Services admitted “we are aware that there have been reports in the medical literature between frequent female perineal talc dusting over a protracted period of years, and an incremental increase in the statistical odds of subsequent development of certain ovarian cancers.” Then, amazingly, this official went on to say that the FDA “is not considering to ban, restrict or require a warning statement on the label of talc containing products.”

Aware of talc’s extreme dangers and alarmed by continued governmental unresponsiveness, in 1994 the Cancer Prevention Coalition, supported by the New York Center for Constitutional Rights, submitted a Citizen’s Petition to the FDA. This requested that talc genital dusting powder be labeled with an explicit warning of the major risks of ovarian cancer. However, the FDA again denied this petition.

In May 2008, the Cancer Prevention Coalition submitted another Citizen’s Petition to the FDA. This was endorsed by a range of groups including the Organic Consumers Association, the International Association for Humanitarian Medicine, and Dr. Faye Williams of the National Congress of Black Women. We cited new scientific evidence on the dangers of talc, and requested the FDA to mandate that all talc products be labeled with this type of warning: “Frequent application of talcum powder in the female genital area substantially increases the risk of ovarian cancer.” However, Andrew von Eschenbach, M.D., then Commissioner of the FDA, failed to respond to this petition.

It is anticipated that Margaret Hamburg, M.D., the highly respected new FDA Commissioner, will take prompt regulatory action to protect unsuspecting women from the extreme dangers of talc.