Keeping you up to date with the latest consumer alerts, product warnings, and recalls related to prescription drugs and medical devices.
The Food and Drug Administration (FDA) is the administration org in charge of the regulation and checking of most sorts of nourishments, pharmaceuticals, therapeutic gadgets, and beautifying agents. Made in 1927, the FDA was initially shaped from a rearrangement of the Bureau of Chemistry. Throughout the years, the FDA has lost and picked up administrative forces of our nation’s items. The Food, Drug, and Cosmetic Act of 1938 stretched the measure of items that the organization was in charge of checking. There have been numerous alterations to the Fd&c Act throughout the years, permitting the office to create better systems to direct our items and to diminish the time taken to “favor” an item for shopper utilization.
The FDA has two significant obligations:
1. Inspect recently created nourishment, therapeutic, and nonessential items for wellbeing and dangers. This incorporates supporting safe items and dismissing items that don’t meet the nation’s security measures.
2. Request reviews for items that have been discharged into the business, yet that are not ok for buyer utilization.
A sustenance review is a move made by a specific firm to expel items from the business. These could be led by the firm itself, on appeal from the FDA, or by FDA request. By and large, when we find out about the FDA “requesting” a review, it has really just made a composed solicitation. The FDA is just approved to make a request if a medicinal gadget, newborn child equation, or human tissue items represent a genuine wellbeing danger. Accordingly, just about all nourishment reviews are indeed just demands that the maker is following.
There are a few diverse sorts of sustenance review.
Classes of Food Recall:
Class I Recall: This is a circumstance in which being laid open to or utilizing an item is liable to cause genuine wellbeing issues, or even demise of the client.
Class II Recall: In this circumstance, utilizing or being laid open to the item may cause treatable or brief medicinal conditions. Then again, in this class, its impossible that individuals influenced by the item will experience the ill effects of genuine or lasting wellbeing issues.
Class III Recall: This is a circumstance where an item is in violation, however presentation to it or utilization of it isn’t liable to cause wellbeing issues.
Market Withdrawal: This happens when an item has just a minor violation. This violation is of the sort that wouldn’t be liable to legitimate movement from the FDA, and the item is evacuated voluntarily. An item which had been messed with, however demonstrated no issues in assembling or circulation, is an instance of business withdrawal
In the event that you feel that an item you’ve purchased ought to be liable to a nourishment review, you may contact the FDA to report the issue. Any nourishment item is qualified, and additionally medicinal gadgets, solution, blood thinners, and things identified with sustenance creating creatures. On the off chance that customers don’t make reports, issues may go unnoticed for quite a while. To report a crisis, you ought to contact the organization’s primary 24 hour crisis number 301-443-1240. Non crises could be steered to your area office buyer protestation facilitator. Be that as it may, if meat is included in the issue, you’ll need to steer your dissention to the Department of Agriculture, since the FDA does not handle these issues specifically.
The FDA is an imperative controller of the nourishment we consume. On the off chance that we were not fit to review items which are in violation of the law, a large number of passing could come about. This is the reason its generally imperative to agree to any sustenance review you see data about, and to report any issues you may find with a nourishment item.
Stryker Hip Implant Recalls and Lawsuits Overview
On July 6, 2012, the Stryker Corporation, among the world’s biggest producers of orthopedic implants and medical equipment, recalled two of its own hip implant systems. The names of these implant systems were the ABG II Modular and the Rejuvenate Modular Neck Hip Stems. The business ceased creation and all international sales of the parts.
The Accolade TMZF, another hip stem implant, also caused difficulties. Those versions were recalled by the business because of production and packaging mistakes in 2009, 2011 and 2013. It causes a lot of the same issues as both of the other stems.
After several men and women endured debilitating unwanted effects like bone and tissue destruction in early device failure at the implant site, Stryker is faced with lawsuits filed by plaintiffs as well as patients’ family members.
The neck parts of the ABG and Rejuvenate II are made from cobalt and chromium, and the stems are coated with titanium. Over time these parts rub against each other and can result in metal debris being released, which can cause injuries and complications at the site of the implant. This is the ultimate reason for the Stryker Hip recall.
Stryker released a notice to inform former patients of the potential dangers related to the implants. Some of the possible complications include the following:
• Corrosion and fretting in the vicinity of the neck junction that is modular can discharge excessive metal debris to the nearby tissue. This can cause death to surrounding soft tissue.
• Patients with metal susceptibility could possess a serious allergic reaction that will require revision operation. This is known as metalosis (metal poisoning).
• Excessive metal debris in the joint space could need revision operation, and can cause osteolysis, also called bone loss.
Moreover, some research has suggested connections between heart and neurological issues due to the immersed metal ions. Other possible connections include injuries to the lymph nodes, spleen, liver and kidneys. Cobalt is recognized as particularly hazardous.
That is not the first-time a hip implant has been recalled by Stryker. In 2008, the business recalled its Trident Hemispherical cups and Trident Acetabular PSL. Also, their Accolade Femoral stem was recalled in 2012, because the revision rates were high. Stryker refuses to comment to the specific failure and revision rates of the ABG II and Rejuvenate implants.
Shortly following the recall, several individuals who endured complications like fractured hips, bone and tissue damage, in addition to debilitating pain filed suits against the manufacturer.
One individual had filed a Stryker lawsuit after his Stryker hip failed shortly after it had been planted, and he ended up having revision surgery several months later. He stated that simply getting out of the car is an ordeal and it is difficult to remain seated for quite long.
Suits filed against Stryker allege the business was negligent in failing to warn people regarding the high rate of failure. In addition, they accuse the business of creating deceptive claims that the titanium, cobalt and chromium parts in the ABG and Rejuvenate II would not corrode or fret. Over one billion dollars has been awarded to victims and family members via the numerous lawsuits filed.
Individuals who experienced hip replacement surgery ought to check their medical records to determine whether these implants were used. It is also important to note that the Stryker hip part could be recorded under a product name that is different.
Stryker Corporation recalled two of its Hip Implant Systems
The Stryker Corporation, one of the world’s best makers of restorative supplies and orthopedics gadgets, reviewed two of its fake hip insert frameworks named as-
The Rejuvenate Modular and ABG II Modular-Neck Hip Stems. The organization ceased all his worldwide offering and generation of all these segments and now the organization confronts support claims recorded by patients who got the reviewed hips.
In April 2012 the Stryker Hip Recall was announced, —
Stryker issued an Alert for wellbeing to specialists for the two hip substitution frameworks. The caution recorded “over the top metal trash and/or particle era” as one of the dangers to patients. As indicated by Stryker’s “Caution for Safety”, the accompanying issues can come as an issue:
Metallosis (arrival of metal particles into the tissue and circulatory system). Rot (untimely tissue demise). Osteolysis (bone disintegration). Agony and loosen of the hip insert obliging amendment surgery.
On July 6, 2012, —
Doctors and well being controllers have centered significant consideration on the dangers to patients from the arrival of lesser metallic particles by, and the expansive and boundless disappointments of, all-metal (additionally called metal-on-metal) hip insert. Stryker’s Rejuvenate and ABG II measured neck hip stem frameworks are not viewed as metal-on-metal gadget, since they don’t have a metal ball. On the other hand, the Stryker hip review Rejuvenate and ABG II necks are made of chromium and cobalt, and stems got covered with titanium metal, they do have a metal-on-metal intersection and can discharge metallic flotsam and jetsam into close-by tissue and the circulation system. Stryker’s official review declaration expressed that the organization’s choice to “uproot Rejuvenate and ABG II stems and end worldwide circulation of these items comes after proceeded with post-market observation. The organization’s “VP and general supervisor” of hip restoration, Stuart Simpson, he said we will keep on evaluating the information. The neck parts of the Rejuvenate and ABG II are made of chromium and cobalt, and the stems are covered with metal called titanium. At the point when all these parts wear against one another where the neck meets the stem.
Under the settlement, the Stryker hip lawsuit may give a base installment of $300,000 to patients that got the Rejuvenate or ABG II hip frameworks. The base honor may be balanced upward relying upon specific elements. Like, installments will be expanded for unprecedented restorative wounds, for example, different surgeries (re-amendments) or diseases and other therapeutic inconveniences, for example, Metalosis (metal harming), worrying, consumption, disengagement, passing of encompassing delicate tissue, endured as an issue of correction surgery and Patients with metal affectability may have an extreme unfavorably susceptible response that obliges modification surgery
The due date for qualified patients to submit their cases for installments under the settlement in March 2, 2015. The main installments under the settlement project are required to start in the mid-year of 2015 with upgraded installments being anticipated for payment toward the end of 2015 and early 2016.
Critically, the Stryker settlement is not for an altered whole. As such, Stryker’s preeminent obligation is not confine. It is normal that aggregate sum of installments under the settlement will far surpass $1 billion dollars for the recalled hips by Stryker. To proactively deal with the cases process, Stryker has overseeing banded together with a main outsider claims head to work specifically with patients to oversee repayment of medicinal expenses and address out-of-pocket expenses identifying with this review. Claims documented against Stryker hip review assert that the organization was careless in neglecting to caution general society about the high evaluating of disappointment. They additionally blame the organization for making false claims that the titanium and cobalt chrome neck and stem in the Rejuvenate and ABG II were impervious to fussing and corroding.
Benicar FDA Warning Included on Olmesartan based products
Benicar is the brand name of drug, olmesartan medoxomil. It is prescribed to treat high blood pressure, otherwise known as hypertension. It may be used alone, or in conjunction with other medications. Other brands this drug is marketed under are
Benicar HCT, Tribenzor, Azor, and generics. It has been used since 2002.
Olmesartan is classified as an angiotensin II receptor antagonist. It is available in doses of 5, 20 or 40 milligram tablets.
There are many warnings on the Benicar website about those who should not take this drug.
* children, particularly those under one year of age
* women who are pregnant or may become pregnant
* women who are breastfeeding
* have severe kidney disease
* have diabetes
Because it may interact with other drugs, doctors need to be made aware of any other prescription medication that is being taken.
Alcohol should also be avoided when taking this drug.
Benicar Side Effects
Less serious side effects include headaches, sinusitis, back pain, dizziness, bronchitis and hematuria.
Mayo Clinic Study
A study done by Dr. Joseph Murray and the Mayo Clinic found that Benicar can cause serious intestinal problems, otherwise known as sprue-like enteropathy. A study of 22 hypertension patients taking Benicar between 2008 and 2011 at the Rochester, Minnesota Mayo clinic saw severe side effects, including significant weight loss. 14 patients required hospitalization due to weight loss; other side effects included nausea and vomiting. In each case, patients were first tested for celiac disease, which was ruled out 100% of the time. Patients were between the ages of 47 and 81, the mean being 69. Most patients were taking a dose of 40 mg per day.
The clinic suspected a link between the drug and the disease when two consecutive patients were referred to the clinic with suspected celiac disease. The patients reported a marked improvement while hospitalized, and a prompt relapse when released from the hospital. The medications for hypertension were withheld while hospitalized. During this time, the clinic was also studying patients who had symptoms of enteropathy; it was discovered that more than one-third of those patients were recently prescribed olmesartan medoxomil.
The study concluded that once taken off of olmesartan, patients’ health improved significantly. They all gained weight and were able to eat a normal diet. Stomach pains, chronic diarrhea and vomiting disappeared, and patients were able to continue with their normal, daily routines.
Symptoms of sprue-like enteropathy include:
* substantial weight loss
* severe and chronic diarrhea
Symptoms can develop within a few months or a few years of taking the drug. The study also found that discontinuation of olmesartan improved the symptoms in all patients.
Benicar FDA Warning
As a result of the Mayo Clinic study, an FDA warning label has been placed on all Benicar packaging, and other marketed brands to indicate the intestinal problems that may occur as a result of taking the drug. The FDA will continue to monitor any studies, reports, or findings regarding this and other conditions that develop. If and when new data becomes available, the FDA will communicate it to the public in a timely manner. More studies are being conducted about this drug and others that are being developed.
Lack of an Antidote for Xarelto is creating major problems for its users
Xarelto is an anti-coagulant used for treatment of blood clots, pulmonary embolism and DVT. It is a very effective drug and this is why in the year 2011 on the 4th of November, the Food and Drug Authority approved this drug for use in hospitals to treat these conditions. A lot of people have benefited from using this drug and have gotten better. However, there are people who have also suffered very serious side effects from taking this drug. There are several Xarelto side effects that patents ought to be aware about in order to notice the signs of the beginning of the side effects.
Side Effects Associated with Xarelto
One of the most common side effects Xarelto has is it causes G.I. bleeding. The reason why this drug causes this side effect is the fact that it normally functions like a blood thinner. Therefore, it may cause excessive thinning to the blood which may in turn cause internal bleeding. This is very dangerous especially if a person on the drug gets involved in an accident and they are suffering internal bleeding. It may be impossible to save the person because there is no antidote for Xarelto. Normally, other blood thinners have antidotes that are used for emergencies for internal bleeding. The antidotes are used to reverse the internal bleeding to save the person’s life. This is impossible with Xarelto. Since it is impossible to reverse internal bleeding caused by Xarelto, often times most people die as a result of internal bleeding.
How to detect Internal Bleeding
Since there is no antidote for Xarelto, there are several ways a patient can tell whether they are experiencing internal bleeding in order to make sure they get to the doctor before the condition gets serious. Some of the signs of internal bleeding are; bleeding gums, vaginal bleeding, colored stool and urine, dizziness, headaches, coughing blood, vomiting blood and frequent nose bleeding. If a patient who is on Xarelto sees any of these signs, he or she ought to see their doctor in order to take the necessary actions before the condition gets any worse.
Other Problems related to the use of Xarelto
Apart from internal bleeding Xarelto also causes abnormal liver functioning. Like with internal bleeding, a person taking Xarelto is supposed to watch out for any signs that show that the liver is not functioning normally. Jaundice is one of the symptoms that show that the liver is not functioning as it should. The common sign that appears when a person is suffering from jaundice is the yellowing of the eyes. Bloody urine and colored stool is also a sign that a person may be suffering from a liver dysfunction. If a patient sees any of this abnormal signs, they ought to visit their doctor in order to ensure the situation is dealt with before it gets any worse.
In conclusion, taking Xarelto is recommendable because the drug is very effective as an anti-coagulant. The only disadvantage of this drug is the fact that it has no antidote. However, the antidote for Xarelto is not needed in most cases since internal bleeding is a rare side effect.