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FDA Rejects Citizen Petition to Ban Transvaginal Mesh

Regulators at the Food and Drug Administration (FDA) have rejected a petition to ban United States sales of nonabsorbable surgical mesh products for transvaginal repair of pelvic organ prolapse (POP). The petition was filed in 2011 by the consumer advocacy group Public Citizen.

The FDA issued a letter to Dr. Michael Carome, then deputy director of Public Citizen’s Health Research Group expressing sympathy for the petitioner’s concerns and even some level of agreement. However, the FDA did not agree with the proposed remedies, nor that a total ban and recall was necessary.

While the FDA acknowledged worries that transvaginal mesh products pose safety risks to women, it stated that it was already taking steps to counter those concerns. According to the FDA in its response, “There is not sufficient evidence at this time to support a finding that there is a reasonable probability that all nonabsorbable surgical mesh products specifically designed and labeled for transvaginal repair of POP would cause serious, adverse health consequences or death.”

The Future of Pelvic Mesh Products

While the outright ban of nonabsorbable pelvic mesh products is not going to happen, there will be changes in the way the FDA treats these devices in the future. The FDA issued a tentative reclassification order to upgrade transvaginal mesh products to Class III. This would require premarket approval for all related devices.

Furthermore, the FDA has made safety communications about the risks posed by transvaginal mesh required before use and has increased post-market scrutiny. The FDA even stated that there was some evidence that there were measurable benefits to using surgical mesh when transvaginally repairing pelvic organ prolapse.

These actions have not totally placated concerns by consumer organizations who are worried about the side effects of transvaginal mesh, including vaginal scarring, shrinkage, and pelvic pain.

Public Citizen has stated that actions taken by the FDA are “backward” in the case of this product. Furthermore, they believe that while the higher regulatory scrutiny will be good for consumers, the FDA is undercutting its effectiveness in two ways. First, they believe that the FDA’s allowance of 510(k) clearance for transvaginal mesh products goes against purposes of the intensive premarket approval process. Secondly, they worry that the length of time for the installment of the reclassification will hurt women in the meantime.

Despite this fact, many organizations view these actions by the FDA as a step in the right direction. With added oversight, there is hope that the true health risks and benefits of transvaginal mesh can be known.

This response by the FDA does not preclude it from issuing a recall later. Many manufacturers of transvaginal mesh have been sued by patients who have been treated with nonabsorbable pelvic mesh, and researches on the products are still being conducted.

In the end, the FDA has a responsibility to take any accusations of patient risk seriously, so this is not the end of investigations regarding transvaginal mesh products.

Source:

http://www.fiercemedicaldevices.com/story/fda-rejects-petition-ban-transvaginal-mesh/2014-07-16

FDA to Decide If Testosterone Meds Boost Heart Attack Risks

The Food and Drug Administration (FDA) has decided to hold a special advisory committee meeting to discuss the potential cardiovascular risks posed by testosterone products. This meeting, to be held on September 17, 2014, will be spent examining two recently released trials that indicate that testosterone products may increase the risk of heart attacks in men.

At this advisory meeting, the FDA Bone, Reproductive, and Urologic Drugs panel and the Drug Safety and Risk Management committee will jointly discuss what implications these studies have for consumers and the general safety of testosterone products.

This safety reassessment is the culmination of a months-long investigation by the FDA. The agency has been researching claims made in the testosterone market and the safety of such products. The FDA has already put a warning on all testosterone drugs about blood-clot risks posed by these products. Depending on the outcome of these hearings, the market may be more tightly regulated or some products could even be banned.

Concerns about Testosterone Medications

In recent years, men have been buying testosterone medications in increasing amounts. The drugs for low testosterone count, or hypogonadism, are intended to increase sex drive, improve mood, and strengthen muscle tone. While testosterone medications have been advertised as a panacea for any male problem, the medications for “Low T” may pose serious risks. As the testosterone market is currently valued at $1.6 billion and is expected to grow to $5 billion by 2017, it is important for the FDA to take an active role in determining the health impact of these drugs.

A study of 55,000 men taking prescribed testosterone medications in the United States found that in the first 90 days using testosterone drugs, 1 in 167 men aged 65 or older could suffer a heart attack. These risks increased to 1 in 100 men under 65 for those with pre-existing heart conditions. These risks are more than double the normal risk for men in this age bracket. There were nearly doubled risks for younger men with previous risk factors for cardiovascular problems.

Many doctors have expressed concerns about these medications, and the FDA is taking these concerns seriously. However, the risk may be mitigated by other factors. The solution to make these drugs safer may be in requiring more stringent patient testing before starting the medication.
Source:

http://www.fiercepharma.com/story/do-testosterone-meds-boost-heart-attack-risks-fda-asks-advisory-panels-weig/2014-07-22?utm_medium=nl&utm_source=internal

CorticoSteroid Epidural Injections Warning by FDA

The FDA has issued a warning to medical professionals who use corticosteroid mediations for epidural injection for relief of pain. This measure was instituted after a number of serious reactions were reported in patients who received this treatment. Patient with long-term back or neck pain should consider the risks before undergoing this type of treatment for pain management.

Corticosteroid Medications

Steroids are powerful medications that are often used to reduce inflammation and pain caused by a number of medical conditions. A growing trend toward using these medications for spinal problems has brought attention to some of the serious reactions associated with its use. These drugs are injected into the spine using a number of different techniques. Corticosteroid drugs are available under a number of different names. Betamethasone, hydrocortisone, methylprednisolone, dexamethasone, and triamcinolone are just a few forms that are commonly used by physicians.

Epidural Corticosteroid Injection Procedures

Corticosteroid injections have become a popular method for treating low back pain, spinal stenosis pain, and nerve problems that radiate into the extremities. In this procedure, x-rays help to guide the physician into the correct position for injection of the medication. The surface skin is numbed with a local anesthetic. The medication is then deposited around the appropriate nerve root. Although the procedure has been considered low risk with only a few problems of inflammation of nerves or elevation of blood sugar, more serious effects have been reported that have made the procedure controversial.

FDA Warning

On April 23, 2014, the U.S. Food & Drug Administration issued a warning for the use of corticosteroid epidural injections for treating back, neck, and radiating pain in the arms and legs. Some rare but serious reactions were reported that cause the agency to issue this warning. Corticosteroid epidural injections used for these purposes can cause vision loss, strokes, paralysis, and sudden death.

Recommendations for Use

Patients should explore other options before undergoing epidural corticosteroid injection treatment. Discuss the benefits and risks of this treatment thoroughly with your physician before consenting to the treatment. Problems resulting from epidural corticosteroid injections are generally associated with physicians that have undergone minimal training in the procedure. Always ensure that your doctor is board-certified to ensure that he or she has sufficient training in the procedure to do it safely.

References:
http://www.recapo.com/dr-oz/dr-oz-advice/dr-oz-dangers-vs-benefits-of-epidural-steroid-injection-for-back-pain/
http://www.spinehealth.com/medications-steroids.php
http://www.spinehealth.com/epidural-steroid-injection-pain-management.php
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394530.htm

Sun Pharmaceutical Drug Plant Was Banned By The FDA

A Sun Pharmaceutical Industries, Ltd. drug plant located in India was banned from exporting products into the US after the Food and Drug Administration found onsite garbage pileup, testing flaws, and a laboratory that was described as “uncleanable.” FDA inspectors found that some lab workers had manipulated test data and eliminated undesirable results. Furthermore, rodent traps were found, and bathrooms were not in working order. A substance that appeared to be human waste was observed on a bathroom wall and there was a strong smell of urine. The plant manufactures the antibiotic cephalosporin and bulk ingredients that comprise the drug.

The Karkhadi, India laboratory yielded less than one percent of Sun Pharmaceutical’s revenue in 2013. However, the company’s stock may decline in value if violations continue to be observed. The company reported in an email that it has since implemented corrective steps at the plant to improve cleanliness, and defective equipment has been replaced. Disciplinary action has been taken in instances in which the proper testing procedure was not followed. Nevertheless, Sun has not made a final decision on whether the factory will be closed.

Over the past year, the FDA has issued approximately 20 similar bans against pharmaceutical plants in India exporting products to the U.S. The most recent ban was issued in January 2014 against Ranbaxy, where workers were found to have altered test results by overwriting raw data that had been collected on samples for more than five months. Sun agreed in April 2014 to purchase Ranbaxy despite the ban that was placed on four of the company’s laboratories.

Indian pharmaceutical manufacturers have become a major exporter to the U.S. as demand for cheaper generics has increased. These companies also provide affordable pharmaceutical products to countries in Africa. Due to several suppliers being subjected to FDA sanctions as a result of not meeting manufacturing standards, Indian pharmaceutical factories have come under great scrutiny within the past year. A spokesperson from Ernst & Young noted that the reported issues are not necessarily due to a lack of standards in India; however, drug factories can get away with violations more easily.

Reference:
http://www.bloomberg.com/news/2014-04-25/fda-banned-sun-plant-after-finding-data-flaws-rat-traps.html

Recent FDA Warning Letters Issued

In April of 2104, the FDA published nine warning letters to various food manufacturers. A warning letter is the FDA’s primary method of notifying manufacturers that they are not in compliance with the administration’s Current Good Manufacturing Practice, the Federal Food, Drug, and Cosmetic Act or other regulations. The warning letter is usually the first serious action taken after an inspection has uncovered violations serious enough to take action.

FDA Enforcement

Some of the violations uncovered in the April letter included unacceptably high levels of drugs in animals for slaughter, unacceptably high levels of pesticide residue on produce, unacceptably high levels of toxins produced by molds and unsanitary working conditions and food storage conditions. These violations all pose health risks to any consumer who may eat the contaminated product.

The FDA is hoping that a warning letter will trigger voluntary compliance actions. In general, the letter outlines the specific violations and instructs the company to correct the violations within a certain period. If the company fails to correct the violations, the FDA will administer actual penalties. The FDA will usually follow the warning letter with an additional inspection to see if the company has restored compliance. Further legal actions can include fines and recalls up to the closure of the facility that is handling or processing the contaminated food items.

Warning Letters and the Public

Warning letters can still have serious consequences for manufacturers because they are published publicly and can greatly affect the company’s ability to do business, find new clients and sell additional products. A warning letter also provides legal leverage for a consumer who may have been harmed due to contaminated foods.

Many consumers who suffer due to a serious food poisoning or food borne illness can use strict product liability laws to their advantage if they choose to file a lawsuit to reclaim damages for their injuries or illness. Food-borne illness can cause serious injury, large medical bills or even death if not promptly treated. Children and the elderly are especially susceptible to food-borne illnesses.

Under the concept of strict product liability, consumers must only prove that the food they ate was contaminated and that the contamination led to their illness or injury. Since contamination can happen at any stage of food production, a case will attempt to trace that food back along its entire production path. If that path leads to a company or facility that has been issued an FDA warning letter, grounds for a successful lawsuit against that firm increase dramatically.

Warning letters protect both consumer and producers from the more serious consequences of contaminated food by bringing issues to public attention and giving producers a chance to clean up their act and hopefully avoid more serious consequences.

Sources:
http://www.foodsafetynews.com/2014/04/fda-warning-letters-pesticides-mycotoxins-adulterated-dietary-ingredients/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+foodsafetynews%2FmRcs+%28Food+Safety+News%29#.U
http://www.nolo.com/legal-encyclopedia/lawsuits-involving-food-poisoning-29673.html
http://compliance-insight.com/fda-483-warning-letters/