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A Johnson & Johnson drug that treats type 2 diabetes in a new way is now approved by the U.S. Food and Drug Administration (FDA). Invokana, as the drug is known, will work by excreting blood sugar in the patient’s urine rather than affecting the supply or use of insulin.
This new type 2 diabetes drug falls in a class of medications called SGLT2 inhibitors. The drugs work by blocking action of the sodium-glucose co-transporter 2, which takes sugar removed from the blood by the kidneys and puts it back into the blood.
Prior to its approval, clinical trials with more than 10,000 patients revealed that Invokana improved blood sugar levels and led to lower blood pressure and weight loss. Among the estimated 26 million Americans with type 2 diabetes, many are prescribed medications that lead to weight gain and hypoglycemia, two dangerous health risks.
Clinical trials of Ivokana showed additional side effects that could be serious. These side effects include:
- Raised LDL (bad) cholesterol levels
- Vaginal yeast infections
- Urinary tract infections
- Elevated stroke risk
- Small heart attack risk
The significance of the side effect findings remains unclear, according to the FDA. The label of Invokana includes no warnings about heart attack or stroke risk. However, the FDA requires Johnson & Johnson to conduct five post-marketing studies and one clinical trial to conclusively determine if the drug does increase risk of stroke and heart attack.
Despite possible serious side effects, Invokana is available to consumers at a wholesale price of $8.77 per tablet. Johnson & Johnson states the price of Invokana is competitive with other diabetic medications.
Read more about the FDA approval of Invokana here.Comments (0)
A New Jersey jury has ruled Johnson & Johnson must pay $11.1 million to Linda Gross, of South Dakota, for her injuries resulting from the company’s transvaginal mesh implant product. The jury awarded Gross $3.35 million in compensatory damages and $7.76 million in punitive damages, resulting in a total verdict of $11.1 million.
Gross, 47, underwent 18 corrective surgeries after the device was implanted and suffered numerous debilitating side-effects. The jury ruled that Ethicon, a subsidiary of J&J and manufacturer of the device, failed to properly warn Gross of the risks associated with the transvaginal mesh implant and made fraudulent misrepresentations about its benefits.
The case is Gross v. Gyncare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City). The suit alleged failure to warn and fraudulent misrepresentation of the dangers associated with the Gyncare Prolift vaginal mesh product.
Gross filed her suit after she underwent surgery to install the transvaginal mesh medical device to treat pelvic prolapse. She spoke with her doctor and read a brochure supplied by Ethicon, leading her to believe there was little risk and that the mesh could be removed easily.
Instead, the mesh implant lead to a series of complications and problems, Gross testified, including mesh erosion, scar tissue, inflammation, hardening of the mesh, pain while sitting and 20 prescriptions for medications to help her with pelvic problems.
In August 2012, Johnson & Johnson stopped selling four types of mesh devices, including the Gyncare Prolift because, according to the company, the products “lacked commercial viability”.
This is the second verdict related to the dangers associated with transvaginal mesh implants. The ruling could have an impact on the other lawsuits against other manufacturers of similar products.
Owes $7.76 Million in Punitives in Vaginal Mesh Case
Bloomberg, Feb. 28, 2013
awards $3.35 million in vaginal mesh case against J&J
Reuters, Feb. 25, 2013
Bloomberg Businessweek, Feb. 25, 2013 Comments (1)
When Ameridose, the company linked to the recent meningitis outbreaks and production of contaminated steroid injections closed its doors for the remainder of the year, many people worried about drug shortages. Since then, the FDA has been working to offset the drug shortages produced by the closing of Ameridose.
The FDA sees its role in dealing with drug shortages as a high priority, understanding that these medications are needed by people to stay healthy and treat illnesses. The administration reports the number of medications in short supply was 251 in 2011. In 2012, the FDA worked with drug manufacturers to deal with shortages of 145 drugs.
In regards to the closing of Ameridose and its lack of drug production, the FDA is taking the following steps:
- The administration is working with manufacturers of drugs previously supplied by Ameridose, requesting them to increase production if they are able.
- The FDA is offering assistance to any drug manufacturers that are having production problems to ensure production is of safe and high quality.
- The FDA will continue to expedite the reviews of any pending applications that may assist with addressing drug shortages.
- The FDA is identifying additional manufacturers willing to produce drugs in short supply.
- If needed, the FDA will explore overseas companies that are willing and able to import medications to aid in the shortage.
In an FDA Voice post by Margaret A. Hamburg, M.D. and Commissioner of the FDA, Hamburg writes, “[w]e at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.”Comments (0)
More than one month ago, fungal meningitis cases began appearing from the use of tainted steroid injections, resulting in a total of 37 deaths. The 42-day risk period for contracting fungal meningitis from these injections ended on November 7, but new cases of meningitis and infections continue to develop. Some of these new cases appear to be in individuals previously treated and sent home.
Since December 12, the Centers for Disease Control have reported 39 new spinal infections that are not meningitis, five new cases that are meningitis, and three new joint infections.
“Here’s the perplexing issue,” said Dr. Tom Chiller, deputy chief of the Centers of Disease Control and Prevention’s mycotic disease branch, in an ABC News article. “Why are we getting people that early on who are presenting with rip-roaring meningitis, but now, they’re presenting 100 days later with focal infections only? Why the difference? We don’t know.”
Previously, an investigation by the FDA revealed that about one-quarter of the steroid vials in an NECC bin contained a “greenish black foreign matter”, as disclosed in an FDA report released on October 26. This report also identified rooms where sterile products were produced that had mold or bacterial growth.
Approximately 14,000 people received injections that were tainted and produced by a New England Compounding Center in Massachusetts, which later recalled all of its products and shut down for the remainder of the year.
“We hope we’re nearing the end of this,” Chiller said.
Read the full ABC News article here: http://abcnews.go.com/Health/fungal-meningitis-cases-spinal-infections-baffle-doctors/story?id=17937366#.UNHNS6zqR4tComments (0)
Are energy drinks a hazard to our health? Recent news regarding a wrongful death lawsuit involving a 14-year-old girl who died after drinking two 24-ounce cans of Monster Energy within 24 hours suggests this may be a possibility. Should the Food and Drug Administration (FDA) step in and do more to regulate the use of energy drinks?
The New York Times reports a letter was released by the FDA on November 21 discussing the future plans of the administration regarding energy drink-related injuries and deaths. The letter states the FDA plans to “seek advice from outside experts to help determine whether energy drinks posed particular risks to teenagers or people with underlying health problems.”
Health Hazards Linked to Energy Drinks
Numbers show the amount of people visiting the emergency room for energy-drink related reasons has increased ten-fold since 2005. This year, the FDA reports 18 deaths related to the consumption of drinks such as 5-hour Energy and Monster Energy. The lack of awareness regarding the high volume of caffeine contained in the drinks could be a factor, especially in regards to heavy consumption.
Among the reports of injuries or deaths caused by energy drinks, which include 5-hour Energy, Monster Energy and Rockstar energy drinks, WebMD reports the following:
- Deaths due to heart attack or suicide linked to 5-hour Energy
- A miscarriage linked to 5-Hour Energy
- Convulsions, life-threatening fear, deafness and hemorrhage linked to Monster Energy
- Hospitalization due to irregular heartbeat, severe diarrhea, migraine, psychotic disorder, heart attack, and/or vomiting linked to Monster Energy
- Disability from irregular heartbeat or stroke linked to Rockstar Energy
- Hospitalization due to psychotic disorder, increased heart rate or loss of consciousness linked to Rockstar Energy drink
The FDA reports, however, that “there is no scientific literature that calls into question the safety of taurine and guarana, two ingredients often used in energy drinks” yet the AP reports the administration is now “studying energy drinks to see if they posed a risk when consumed by ‘vulnerable groups’ such as young people, or in excess,” but is not planning to take action against the energy drink manufacturers any time soon.
When consumed in moderation, energy drinks are as safe as consuming a few cups of coffee. It’s when heavy consumption comes into play that serious health hazards sometimes arise.
Explore more information on the most recent energy drink litigation and the link between energy drinks and serious health hazards from the Simmons Firm now.Comments (0)
The meningitis outbreaks that took place in October and November made headlines for much of the past month. Following the death of 32 people from the outbreaks, the FDA discovered a link between the meningitis cases and contaminated medications, primarily injectable drugs manufactured by the company Ameridose.
Following the link to Ameridose, the company recalled all of its products, causing many hospitals to worry about a shortage of supply of these medications, which are commonly given as shots or intravenous drips during surgery. One of these drugs formerly produced by Ameridose, sodium bicarbonate, is used in emergency care to return the acidity in a patient’s blood to normal levels. Another of the primary Ameridose drugs is succinylcholine, a medication used by anesthesiologists during surgery to temporarily paralyze neuromuscular functioning.
Soon after the recall of the drugs linked to the meningitis deaths, Ameridose announced the lay-off of hundreds of employees. This was caused by an on-site investigation by the FDA that found the company needed to make vast improvements to its sterility testing process.
By mid-November, the company had decided to remain closed for the rest of the year while the investigations by state and federal authorities continue. The reopening of the facility depends on whether further unsanitary conditions and questionable disinfectant practices are found.
The issue of drug shortages remains a concern, as the American Hospital Association declares in a Reuters article that “82 percent of hospitals said patients had experienced delays in treatment due to drug shortages”, with 50 percent of those hospitals saying the shortages prevented them from providing the proper treatment to patients in need.Comments (0)
The October 2012 QuarterWatch report from the Institute for Safe Medication Practices details the number of drug complaints received by the FDA over the past four years. Prescription medication complaints issued to the FDA have risen 90 percent between 2008 and 2012. This increase amounts to an additional 27,290 cases per quarter1.
“All the increase was attributable to reports from drug manufacturers rather than cases submitted directly to the FDA,” the report claims1.
Prescription medications Pradaxa and Chantix are said to make up 37 percent of the 90 percent increase of serious adverse drug event reports1. The FDA has been investigating Pradaxa and its dangerous side effects since December 7, 2011. The FDA has received hundreds of reports of deaths among Pradaxa users for the year 2011, more than any other prescription medication in that same year.
Pradaxa is a blood-thinning drug meant to treat atrial fibrillation and reduce risk of stroke, pulmonary embolism and other blood-clotting conditions. Contrary to this, Pradaxa has been linked to complicated and often serious health problems such as internal bleeding, heart failure and death.
Other Pradaxa side effects may include:
- Serious allergic reaction
- Chest pain
- Swelling of the face or tongue
- Trouble breathing or wheezing
- Feeling dizzy or faint
- Stomach burning or pain
Pradaxa has been on the market since October 2010 and has been the center of FDA investigations for reports of association with serious injuries. Learn more about Pradaxa side effects, FDA warnings, and issues associated with the blood-thinning drug today.
1 Institute for Safe Medication Practices. QuarterWatch: Monitoring FDA MedWatch Reports. Why Reports of Serious Adverse Drug Events Continue to Grow. October 3, 2012. PDF.http://www.ismp.org/quarterwatch/pdfs/2012Q1.pdf
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