Levaquin, Cipro for bacterial infections may cause irreversible severe harm.

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

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This information is an update to the FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together issued on May 12, 2016

[05-10-2017] As part of our ongoing review of fluoroquinolone antibiotics, FDA is informing the public that patient cases identified by the FDA and findings from published studies currently do not support reports that these medicines may result in detachment of the retina in the eyes, or bulges or tears in the aorta blood vessel called aortic aneurysm and aortic dissection. We will continue to assess safety issues with fluoroquinolones and will update the public if additional actions are needed.

Safety Announcement

[ 7-26-2016 ] The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).

Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.

We urge health care professionals and patients to report side effects involving fluoroquinolone antibacterials and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes

Bayer’s Essure Contraceptive Implant, Now With a Warning

By RONI CARYN RABIN            NOVEMBER 21, 201

Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.

The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.

Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.

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Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.

EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES

“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”

Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.

Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.

F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.

The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.

Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.

“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.

The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.

The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.

Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.

“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.

“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.

Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.

The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”

Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.

The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.

Many doctors who insert the implant do not know how to remove it.

By contrast, drug trials are required to have a comparison group of participants who are given a placebo.

Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.

This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.

The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.

Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.

http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F

Bayer Essure: Permanent Birth Control Pain

Some women say a permanent birth control is causing permanent pain

Leslie Rhode/KXAN Special Contributor  

Published: May 17, 2016, 9:00 pm Updated: May 17, 2016, 11:03 pm

AUSTIN, TX (KXAN) — Essure, a permanent birth control device, is under scrutiny by the Food and Drug Administration after thousands of women have complained of long-lasting painful effects they say are related to the birth control. The manufacturer, Bayer, estimates about 750,000 women are using Essure, and most of them are in the United States.

After Angela Otwell delivered her second child, she thought long and hard about whether or not she wanted a permanent form of birth control. She says her last pregnancy had complications due to an autoimmune condition, but she claims those health challenges cannot compare to the physical and emotional pain she has endured since she got Essure.

The Belton mom was only 28 years old when she had the birth control device implanted in January 2015. Five months later, she had an ovarian cyst rupture she blames on her birth control.

“Ovarian cysts just feel like someone took a very long metal rod that’s sharpened at the end and takes it and skewers it through your body wherever it is,” said Otwell.

For Otwell, the most frustrating part of her life now is the constant fatigue. She says she has lost a great deal of weight and energy since the day she had the permanent birth control implanted. With two young children still not in school, she says she feels so guilty not being the energetic mom her two children deserve.

“I go to the grocery store and that’s about it. I really want a shot at being a mom. I dream of taking the kids to Disney World or, you know, hiking. I just hope I get that opportunity.”

Atwell isn’t alone.

Felicia Crossland lives with fatigue and pain which she also claims was caused by Essure. The Liberty Hill mother loved the idea that the permanent form of birth control did not require anesthesia and down time like having her tubes tied would, so she opted for the devices after her second child. In the years since, she says she often suffers bloating and severe menstrual pain. By the end of most days, Crossland claims the pain becomes too much to bear.

“What happens most nights is there’s this incredible pain that builds in my pelvis and works its way down in my legs,” explained Crossland. “I would like to say it’s something as simple as a pinched nerve, but I really don’t think it is.”

How Essure Works

Doctors insert the small Essure devices into the fallopian tubes through the cervix. Within three months, scar tissue grows around the coils creating a barrier that prevents sperm from reaching the eggs. According to the company’s website, most women go home 45 minutes after the procedure.

Patients are supposed to go back to the doctor after three months for a confirmation check to make sure Essure is working properly to prevent pregnancy. The manufacturer’s website warns women to use other forms of birth control until they pass the confirmation test. Essure marketing indicates the product is 99 percent effective at “permanently preventing pregnancy.”

The Essure coils are made of materials that include a nickel-titanium alloy, a material used in other medical devices like heart stents. The packaging warns patients with nickel allergies may experience an allergic reaction with symptoms like rash, itching and hives. The coils do not contain hormones.

Essure was approved by the Food and Drug Administration in 2002. At the time, the birth control was manufactured by Conceptus, Incorporated. Bayer acquired Conceptus in 2013. Essure received the FDA’s most stringent review before it was marketed and Conceptus was required to conduct two post-approval studies.

According to FDA records, approximately 10,000 complaints have been filed complaining about health complications related to the use of Essure. Records show most women reported pain/abdominal pain, menstrual irregularities headaches and fatigue. The agency says some people reported more than one problem.

The FDA’s website states, “confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.”

On Sept. 24, 2015, the FDA held hearings on the growing number of complaints regarding the adverse effects of Essure. Doctors and patients testified about their experiences with the permanent birth control device.

After the hearing, the FDA ordered Bayer to conduct a post-market study to gather more data about Essure’s benefits and risks. The agency also drafted a boxed warning to make sure a woman knows the risks associated with the product and a patient checklist that doctors review with a woman to make sure she understands the benefits and possible health complications.

Bayer still claims the birth control option is safe for most women and the benefits outweigh the risks.

“The data around the safety and efficacy of Essure has been examined in the company and by the FDA, and the data does not support taking it off the market,” said the Director of US Medical Affairs, Women’s Health Bayer, Dr. Patricia Carney. “Even in the latest statements from the FDA–for the majority of women– essure is a good option.”

The FDA took public comment on the draft box warning and patient checklist for 60 days. That period ended on May 3, 2016.

A bipartisan group of U.S. lawmakers introduced the E-Free Act (H.R. 3920) on Nov. 4, 2015 in hopes of pulling Essure off the market. The bill would require the FDA to withdraw its approval of the permanent birth control.

Living with the Pain

Angela Otwell and Felicia Crossland both say they do not blame their health problems on their doctors who implanted Essure, but rather the device itself.

Otwell and Crossland say they have contacted a new physician who has agreed to remove their birth control devices. Because of the way Essure coils are implanted, the women say the coils cannot be removed without a complete hysterectomy, which is the removal of the uterus.

Both women are waiting on the wording of the FDA’s final boxed warning of Essure, but both wish it would just be removed from the market altogether. There has been no action on the E-Free Act in Washington, D.C.

GAO to investigate FDA regulation of power morcellators.

Government Watchdog to Investigate Hysterectomy Device Found to Spread Uterine Cancer

Government Accountability Office to probe surgical device that was marketed for two decades before FDA issued warnings

By JON KAMP

The U.S. Government Accountability Office confirmed Friday that it plans to investigate a surgical device that was marketed for two decades before the Food and Drug Administration warned it can spread uterine cancer.

Twelve lawmakers wrote the GAO a letter last month asking for a probe into laparoscopic power morcellators, which are bladed, drill-shaped tools gynecologists commonly used to cut up growths called fibroids in minimally invasive surgery, most often hysterectomies. The FDA last year estimated that women who undergo these procedures face 1-in-350 odds that they harbor an undetected cancer that a morcellator could spread and worsen.

“We’ve agreed to do the work,” Katherine Siggerud, managing director for congressional relations at the GAO, confirmed Friday.

In a letter earlier this week to U.S. Rep. Mike Fitzpatrick (R., Pa.), a lawmaker at the forefront of pushing for a GAO review, Ms. Siggerud said the agency accepted his request “as work that is within the scope” of GAO authority. She said the GAO would likely have the staff available to begin its work in about five months.

She said in an interview it was too soon to tell how long a probe might take. An FDA spokeswoman said the agency will cooperate with any GAO review, and does not comment on pending or ongoing investigations.

The probe will likely add scrutiny to how the FDA handled issues with power morcellators going back to 1991—when the first one was cleared for sale in the U.S.—to last year, when the agency cited evidence that the risk of hidden uterine cancers called sarcomas was much higher than many gynecologists believed. Device applications and other records show the FDA knew early on that morcellators could spread dangerous cells, but the agency said the magnitude of that risk wasn’t recognized until the issue gained prominence starting in late 2013.

“I am glad the GAO has agreed to take up this investigation,” Mr. Fitzpatrick said in a statement. “What happened with the power morcellator should never happen again.”

Rep. Louise Slaughter (D., N.Y.) and 10 other members of Congress also signed the Aug. 7 letter to the GAO.

They asked for an investigation into issues such as the FDA’s reliance on a regulatory process used to clear all morcellators for sale in the U.S.; the process has drawn criticism for being too lenient. The lawmakers also asked to know whether groups like hospitals and device manufacturers complied with FDA rules to report problems with the devices, how doctors were trained to use them and what steps the FDA is taking to determine whether morcellators are safe to remain on the market.

The FDA has defended the regulatory process used to approve morcellators and most devices as a good way to balance innovation and safety, and said that the agency is strengthening its surveillance of devices on the market. Johnson and Johnson, formerly the largest morcellator maker before it voluntarily left the market last year, has said that it wasn’t aware of any reportable events regarding morcellators and the possibility of worsened cancer until late 2013.

The FDA in November followed up on its earlier morcellator advisory by calling for a black-box warning, its strongest caution, regarding the cancer risks. The devices still remain on sale from other companies beyond J&J, although many hospitals and health insurers have curbed their use.

My comment:  I blog on FiDA Advocate blogspot.  I was trained 9/2010 at the request of FDA/CDRH to be a Patient Representative on medical device Advisory Panels.  CDRH conducts few  Advisory Panels because most (98%) new devices are cleared through the 510(k) process that simply requires the identification of a 'predicate' device and perhaps a payment of $4000.  If an Advisory Panel is called, the FDA/OSHI - Office of Special Health Issues selects the Patient Representative and this person is a NON-voting member of the panel.  Harmed patients and their advocates are rarely a part of the equation and industry has infiltrated the regulatory sphere.  The system is rigged and patient harm-for-profit is the result.  

http://www.wsj.com/articles/government-watchdog-to-investigate-hysterectomy-device-found-to-spread-uterine-cancer-1441385550