Statin Drug Interactions Warning
Source: US Food & Drug Safety Administration
According to recent FDA warnings, the combined use of commonly used drugs in the treatment of elevated cholesterol (statins) such as atorvastatin, rosuvastatin, simvastatin, or lovastatin, together with some antiviral drugs known as protease inhibitors such as tipranavir, ritonavir, and telapravir, could potentially be harmful or fatal. Symptoms beginning with muscle injury van progress to permanent kidney damage.
DDIs are a subset of adverse drug reactions (ADRs), accounting for about 3-5% of all ADRs. The FDA’s Center for Drug Evaluation and Research cites that approximately 2 million serious ADRs occur annually in the US causing some 100,000 deaths per year. Further, ADRs account for 20% of the injuries occurring in hospitals, doubling the length of stay and the cost of hospitalization. In the UK ADRs were found to be responsible for 6.5% of hospital admissions, and the median length of stay per ADR-caused hospitalization was eight days. The risk of hospitalization due to ADRs is 4x higher in the elderly. Nearly 40% of the ADRs in elderly are likely to be serious, but many of the serious ADRs are also preventable.
US Consumers spend over $300 billion per year on presciption drugs, accounting for about 12% of total health care costs. It has been estimated that ADRs cost us between $30 billion and $130 billion annually. One of the reasons cited for this is the confusing documentation provided with prescriptions. In a report presented at the 28th annual meeting of the American Academy of Pain Medicine, a survey of only 52 patients, revealed that over 80% of those patients were not able to correctly answer questions about the serious adverse effects of an antidepressant medication for which they had all been provided. This despite that 3 different forms of information were provided -a medication guide, a patient package insert, and pharmacy-generated consumer medication information.
There may be as few as a 2-3 dozen two-drug combinations with a high probability of causing serious ADRs, these can easily be overlooked by prescribers or over-ridden in the pharmacy even when identified by pharmacy software as a potential interaction, placing patients at increased risk.
The FDA, academic scientists, and scientists from the pharmaceutical industry are working to develop strategies and guidelines to identify investigational drugs early in the drug development process that are likely to have a cause DDIs. It is hoped that this will lead to fewer adverse events.
If you or a loved one have been injured by a drug interaction or adverse drug reaction, contact the Lewis Law Firm for a free consultation and opinion.
Posted by: Gayle R. Lewis, Esquire
New Jersey Same Day Surgery Center’s Reviewed
Source: NJ Department of Health and Senior Services (NJ DHSS)
What are Ambulatory Surgery Centers?
Ambulatory Surgery Centers or “Same Day Surgery Centers” are facilities where patients can undergo certain types of surgery or medical procedures, recover and go home the same day. Eye, knee and shoulder surgery, cosmetic surgery, and procedures such as colonoscopy screening for colon cancer are examples of services these centers provide.
How many Ambulatory Surgery Centers are there in New Jersey?
There are 133 DHSS-licensed centers in the state. Another 116, though not DHSS-licensed, are certified by the federal Centers for Medicare and Medicaid Services as meeting CMS standards of care. Many other centers come under the authority of the New Jersey state Board of Medical Examiners, which regulates private physician practice.
Patient Safety in New Jersey
DHSS inspects licensed ambulatory surgery centers every three years. Hospitals and ambulatory surgery centers must report to New Jersey’s confidential Patient Safety Reporting System when a serious preventable adverse event occurs. Facilities must conduct a root cause analysis to find the underlying causes of the medical error, and develop and implement a plan to prevent future errors. DHSS, working in conjunction with the Centers for Medicare and Medicaid Services, temporarily curtailed admissions at some ambulatory surgery centers for deficiencies in meeting standards related to infection control, safety, sanitation, medication control, patient safety and other issues. Each of these centers was allowed to reopen after correcting the problems identified.
To learn more, visit the NJ DHSS Patient Safety web site. The Annual Reports contain data on errors and their underlying causes, and track statewide trends in the effort to improve patient safety. By way of example, from the 2009 survey the following issues continue to be problematic:
Falls (preventable) are the largest recurring category of issues in NJ Hospitals and Same Day Surgery Centers
Pressure Ulcers and “Care Management Other” continue to be the next largest subcategories
There has been an increase in the number of reportable device malfunctions, wrong patient/wrong site/wrong procedure events and suicide/attempted suicide in 2009.
The number of retained foreigh objects (RFOs) (things left inside of patients during surgery) remained roughly constant from 2008 to 2009, 27 to 25 RFOs.
If you or a loved one were injured at a New Jersey Hospital or Same Day Surgery Center contact the Lewis Law Firm for a free consultation and opinion. The Lewis Law Firm is committed to improving the quality of medical and hospital care for New Jersey residents.
Posted by: Gayle R. Lewis, Esquire
Fosomax and Fractures
Sources: US Food & Drug Administration; Journal of Oral & Maxillofacial Surgeons
A recent report of Oral & Maxillofacial Surgeons focuses upon the link between bisphosphonates (Fosomax, Boniva, Actonel, Reclast) and osteonecrosis of the jaw. Osteonecrosis of the jaw is a disease in which bone tissue in the jaw does not heal after minor traumas, such as tooth extractions by a dentist. The delayed healing causes the bone of the jaw to become exposed leading to infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue. Other patients experience actual breaking of the jaw on tooth remocal. Patients using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications.
The FDA announced as early as October of 2010 that bisphosphonates, medications to treat osteoporosis (a condition which makes bones brittle) may actually cause fractures of the femur (thigh bone).
Bisophosphonates are drugs which are currently prescribed to more than half a million people diagnosed with osteoporosis. Their prolonged use may be responsible for making bones more brittle. These drugs operate by slowing down the process of osteoclast cells which break down bone and replace it -a natural process. The longer this natural process is delayed, the older the cells which make up the bone actually become. Accordingly, the replacement bone is made up of old bone cells which are more brittle and more subject to fracture with limited or no trauma. Those taking Fosomax for more than 3 years appear to be at most risk for low-energy femur fractures.
Merck, the manufacturer of Fosamax (Alendronate), has largely denied the claims currently the subject of several class action lawsuits, although their labeling has been revised consistent with this information.
If you or a loved one are taking Fosomax, Boniva, Actonel, Reclast or any other osteoporosis drug and you have experienced a low-energy femur fracture or osteonecrosis of the jaw, contact the Lewis Law Firm to determine if you have a case. Our consultation and initial opinion are free.
Posted by: David M. Schwadron, Esquire
Yaz Concerns Continue.
Source: FDA final report Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints (10/2011); Associated Press; NPR Health News
The FDA has now released their report on Combined Homonal Contraceptives (CHCs), such as Yaz, and the increased risk of blood clots in women. The study followed more than 800,000 U.S. women taking different forms of birth control between 2001 and 2007. On average, women taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking older birth control drugs.
From the report directly, “There has long been concern about the risk of both arterial and venous cardiovascular complications imparted by the use of combined hormonal contraceptives (CHCs) in large part because of the prothrombotic effects of estrogen (ethinyl estradiol [EE]). An increased risk of venous thromboembolism [VTE] (deep venous thrombosis [DVT] and pulmonary embolism [PE]) is well established and has been consistently reported”
The FDA concludes that, “[T]he study results add to the small body of literature which shows that the NGMN (norelgestromin/ethinyl estradiol) transdermal patch is associated with higher risk of VTEs relative to standard CHC pills and provides another positive finding to the increasing body of evidence linking DRSP to increased risk of VTE relative to standard low-dose CHC (combined hormonal contraceptive) pills. DRSP was associated with higher risk of ATE in new users overall with this finding restricted to women in the 35-55 years age group only. The finding of increased risk of VTE with the ETON (etonogestrel/ethinyl estradiol ) vaginal ring relative to standard CHCs is new and raises concern but needs to be replicated in other studies.”
The main findings of this study are that all use of the DRSP pill and each of the continuous exposure preparations, the NGMN patch and the ETON vaginal ring, are associated with an increased risk of VTE relative to the standard low-dose OCPs.
Combined hormonal contraceptives are marketed under the following brands and doses:
| Drospirenone and ethinyl estradiol | Drospirenone 3 mg and ethinyl estradiol 0.03 mg |
| Ocella | Drospirenone 3 mg and ethinyl estradiol 0.03 mg |
| Safyral | Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg |
| Syeda | Drospirenone 3 mg and ethinyl estradiol 0.03 mg |
| Yasmin | Drospirenone 3 mg and ethinyl estradiol 0.03 mg |
| Zarah | Drospirenone 3 mg and ethinyl estradiol 0.03 mg |
| Beyaz | Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg |
| Drospirenone and ethinyl estradiol | Drospirenone 3 mg and ethinyl estradiol 0.02 mg |
| Gianvi | Drospirenone 3 mg and ethinyl estradiol 0.02 mg |
| Loryna | Drospirenone 3 mg and ethinyl estradiol 0.02 mg |
| Yaz | Drospirenone 3 mg and ethinyl estradiol 0.02 mg |
Yaz contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium levels in the blood. FDA compared medical records of women taking the drug with those taking the older drug levonorgestrel. Yaz, Yasmin and related drospirenone-containing pills were Bayer’s second-best-selling franchise last year at $1.6 billion in global sales. The FDA reports also highlight complications in women using the Ortho Evra patch from Johnson & Johnson and the Nuvaring vaginal ring from Merck & Co. Inc. Those drugs combine estrogen, which is present in all birth control pills, with two other synthetic hormones launched in the last decade
The FDA has recommended that: “Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills” and that “Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots.”
“At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market,” said Dr. Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women’s health issues. “With all these different birth control options, why take the most expensive one that can also kill you?” Good question, Dr. Zuckerman. Let’s hope that we finally get anwers.
Posted by: Gayle R. Lewis, Esquire
On Liability Waivers and Personal Injuries.
Source: NJ and PA Case Law
In Medicine there is the concept of informed consent. Basically a waiver of being sued for battery (in NJ) or negligence (in PA) for the actual physical touching that necessarily accompanies any surgery or significant medical intervention. (Simplistic analysis or not, that’s what it is).
In general personal injury cases, there is the liability waiver form. If you’ve ever joined a gym, martial arts dojo or yoga studio, then you’ve seen one of these forms before. Typically they contain a short “yes/no” health questionnaire and disclosure of any pre-existing medical conditions and language to the effect that this is a “voluntary activity” with the “potential for injury” but that the member will “Hold harmless” and/or “indemnify” the gym, dojo or studio for any injuries received during the course of participation.
That’s a whole lot of legalese, but does it amount to anything? Well, the Supreme Court of NJ and the Commonwealth Court of PA seems to think so. The primary recent case to come from NJ is Stelutti v. “Powerhouse Gym”, 1 A.3d 678 (2010) 203 N.J. 286. In PA it’s Scott v. Altoona Bicycle Club, 1426 C.D. 2009 (Pa. Cmwlth. 2010), an unpublished opinion which is otherwise fine for the reason that it follows ample precedent including the Stelutti case from across the bridge in the 3d Circuit.
Very briefly, Ms. Stelutti fell during a spinning class (so arguably both cases are bicycle related) causing primarily soft tissue injuries. For Ms. Scott, it was a bicycle race on a public road. Interestingly, the Scott waiver was an online form. In both cases other parties were sued, equipment manufacturer, PennDOT, etc. In both cases, the Courts found that the liability waiver signed (actually and electronically): 1.) did not contravene any public policy; 2.) was clear; and, 3.) was enforceable as a matter of law. The Courts of both states were adequately convinced that the parties were voluntarily undertaking a physical activity and that they knowingly assumed (agreed to) the risks.
Absent some excessively intentional conduct designed to cause injury, it stands to reason that a liability waiver at the dojo, for participating in a course of study of a “Martial Art” should fare similarly. While we are certain that the parties involved in the litigation referenced were well-intentioned, liability waivers for some activities are good for public policy, good for business and generally good for society.
note: In addition to being an attorney at the Lewis Law Firm, after several years of study, the author is currently a 2nd Kyu (Red Belt) in the Japanese Martial Art of Aikido, practicing Kinokawa ryu Aikido at Main Line Budo in Bryn Mawr, Pennsylvania.
Post: David M. Schwadron, Esquire
Antidepressants linked to preterm birth?
Source: Reuters Health; American Journal of Obstetrics & Gynecology, December 2009
Remember that post about the safety of prescription medications for pregnant women? http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=528
Well, researchers in Washington (State not the Nation’s capital) have found in a study of 3,000 women, those taking selective serotonin reuptake inhibitors (SSRIs) into their 2nd and 3rd trimesters had an increased risk (14%) of giving birth prematurely.
Medications such as Zoloft, Paxil and Prozac were felt to have no appreciable impact during the 1st trimester, however benzodiazepines, such as Ativan and Xanax were linked with preterm labor, low birth weight, respiratory distress and low Apgar Scores.
Among the women in the study who did not take any such medications, only 9% gave birth prematurely as opposed to nearly half of the women taking benzodiazepines.
One might very well question why, with the prevalence of such prescriptions, studies such as this were not published earlier.
~Posted by D.M. Schwadron, Esquire.