Articles Posted in Prescription Drugs

prescriptions-fdaAccording to its own website, the FDA “is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices.”

But does the FDA protect the public? As recently reported by Slate magazine:

“When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”

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If you’re young and single, you may think I’m talking about those little glasses of vodka or whiskey meant to be downed in one quick swallow. If you’re a parent of school-aged children, you know I’m talking about back-to-school vaccinations, which are not nearly so enticing.

Way back in 1905, the U.S. Supreme Court upheld the authority of the states to enforce compulsory vaccination laws (Jacobson v. Massachusetts, 197 U.S. 11). Childhood immunizations protect children from diseases which can have serious complications:

Measles – About one out of 10 children with measles also gets an ear infection, and up to one out of 20 gets pneumonia. For every 1,000 children who get measles, one or two will die.

Mumps – This disease can cause acquired sensorineural hearing loss in children. More rare are cases of mumps-associated encephalitis, which can be fatal.

Diphtheria/tetanus/pertussis – Diphtheria was once a major cause of illness and death among children, fatal in up to half of cases, but is no longer a problem in the U.S. due to vaccines. Caused by bacteria entering through a cut in the skin, tetanus can cause muscle contractions and seizures, pneumonia and pulmonary embolisms, with a fatality rate of 10-20%. Pertussis (whooping cough) is highly contagious and can be fatal in infants. In 2012, there were 48,277 reported cases in the U.S.

Polio – Polio is a crippling and potentially fatal infectious disease which has no cure. It spreads from person to person invading the brain and spinal cord and causing paralysis.

These are just some of the common childhood diseases for which vaccines have been developed and for which children must be immunized before attending school or a daycare facility. South Carolina’s immunization program is under the direction of the Department of Health and Environmental Control, and you can see the entire schedule of required vaccines for the 2014-15 school year.

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back-pain-injectionsOn April 23, 2014, the FDA issued a Drug Safety Communication about corticosteroids administered through epidural injection.  Commonly used for back and neck pain, the injections may cause permanent blindness, stroke, paralysis, and death, according to the FDA’s warning.  Other serious adverse events have included spinal cord infarction, seizures, nerve injury, and brain edema.  The reactions may occur within minutes or up to 48 hours after the epidural corticosteroid injection.

The drugs’ labels will now have to carry a warning that these serious consequences can follow when the steroid is administered by spinal injection.  Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

The FDA never approved corticosteroids for injection into the epidural space of the spine.  For decades, however, doctors have been using them in this “off-label” fashion for treatment of chronic pain.  They are, in fact, a common form of pain intervention.  In 2011, nearly 9 million Americans received epidural steroid injections.

It was only a couple of years ago that corticosteroids were in the news after 64 people died of meningitis from contaminated supplies produced by the New England Compounding Center.  The current warning is completely unrelated to that outbreak, however.  Two other factors have prompted the FDA’s concern and latest announcement:  (1) Steroid injections via the transforaminal approach bring a needle within millimeters of critical arteries feeding the spinal cord; and (2) Particulate steroids are slow to dissolve and may create blockages that trigger strokes if accidentally injected into arteries.

The Safe Use Initiative is a program of the FDA which solicits input from medical practitioners about the use of various medications.  In 2012, they convened a group of experts from anesthesiology, orthopedics, neurology/stroke neuro-radiology, pain medicine, and physical medicine and rehabilitation to create guidelines for best practices for steroid injections administered close to the spinal arteries.  They continue to investigate the issue, and the FDA may take further actions in the future.

For the many Americans who suffer with back and neck pain, the FDA urges a discussion with healthcare professionals about alternative treatments.  A patient who has received an epidural steroid injection (ESI) should seek emergency medical attention immediately if they experience vision changes, tingling in the arms or legs, sudden weakness or numbness, dizziness, severe headache or seizures.

People who suffer from back and neck pain and are considering epidural steroid injections for pain management should seek out a highly qualified, experienced doctor who has superior training in the technique, and injections should be given in the appropriate setting, such as an ambulatory surgery center or hospital.  A 2013 investigative report on states:

[T]oday, general practitioners, physician assistants – even some dentists and chiropractors – have started offering ESIs. Some doctors spend just one weekend learning the delicate procedure at training centers that teach cosmetic injections like Botox and fillers, but also teach doctors how to poke around people’s spines. One weekend training center advertises epidural steroid injections as “lucrative specialty options” that “create dramatic earnings for your practice.”

Several multimillion-dollar jury verdicts have attempted to compensate men and women who sought treatment for their pain and wound up with life-long disabilities after being given corticosteroids by spinal injection.  In 2010, a Florida woman and her husband won a $36 million malpractice verdict when she was partially paralyzed by a botched steroid injection for back pain.  A Texas man is nearly blind and in a wheelchair after his treatment; he settled for a confidential sum.  A Texas teacher suffered permanent nerve injury and has difficulty with balance, pain and numbness in her legs and feet; her case is still pending in court.

If you or someone you love has been harmed by a medical practitioner who administered or prescribed a drug in an off-label use, call the South Carolina medical malpractice lawyers at the Louthian Law Firm at 888-440-3211.  When life goes wrong, we fight for what is right.

As we wrote not too long ago, South Carolina is in the Diabetes Belt, with about 450,000 of our residents suffering from diabetes. (Read more here

In the news this week is an announcement by the Federal Drug Administration (FDA) that prescription drug Avandia will now be widely available to treat type 2 diabetes. This represents an about-face by the agency, because they restricted use of Avandia after 2007 clinical trials indicated the drug increases the risk of heart attacks or death.

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A low country pain clinic was one of the healthcare facilities that received a batch of tainted steroids linked to the deadly meningitis outbreak.

Intervene MD, with locations in Mount Pleasant and North Charleston, posted the following on its blog:

“Unfortunately, our practice was one of those provided medications from the manufacturer [New England Compounding Center]. We were notified by the South Carolina Department of Health and Environmental Control (DHEC) on Friday, September 21st that we had received suspect medicines from lots produced between July 31 and September 16. We immediately removed all vials of the medication from use and returned them to the manufacturer.

“Because we are concerned, we have made every effort to determine each and every patient who may have received epidural treatment with this medication. We have personally spoken with almost all of the 189 people affected. We continue to call and work to get in touch with each person who received this medication by epidural injection. There are a few patients we’ve not been able to reach by telephone, despite multiple attempts, and we are sending follow-up letters that detail signs and symptoms to watch for until the possibility of illness passes. Each person has been asked to seek immediate emergency treatment if they have any symptoms. According to the Centers for Disease Control (CDC), this illness takes from one week to one month following exposure to develop.

“It is a relief that none of our patients are showing any signs or symptoms of meningitis. Two — at our urging — have gone to the emergency room for further examination. Tests determined that they do not have meningitis.

“We have been and continue to be available to speak with our patients. We invite them to phone us with any questions, issues or anxiety. We are providing medical counseling and following all CDC recommendations.

“We urge anyone who has recently had epidural treatment for back pain to contact their doctor. If you are our patient and have questions, we want you to call us. Epidural steroid injections for the management of pain have been used for many years and have relieved pain in thousands. This treatment has allowed many individuals to experience an improved quality of life and be more productive.”

If you or a loved one has been directly affected by the meningitis crisis, the South Carolina drug injury lawyers at the Louthian Law Firm in Columbia are available to answer legal questions about your rights and options.

Meanwhile, the first of an anticipated wave of lawsuits over the fatal outbreak was filed October 11 in Minnesota.

According to Reuters news:

“The lawsuit [Barbe Puro v. New England Compounding Pharmacy Inc, U.S. District Court, District of Minnesota, No. 12-2605] was filed in a Minnesota federal court on Thursday by a woman who said she was given a steroid injection for back pain and has experienced symptoms consistent with meningitis. She is awaiting the results of tests.”

The number of people nationwide who have contracted meningitis from an injection of tainted steroids had exceeded 215 as of October 15. More than a dozen have died.

View an infection map from the Centers for Disease Control and Prevention here.

Patients who received a steroid injection at Intervene MD between July and September 2012 are urged to contact a healthcare provider immediately.

View a CDC map of all affected healthcare facilities here.

Get Answers From A South Carolina Drug Injury Lawyer

The Columbia drug accident attorneys of the Louthian Law Firm are available to evaluate cases of injury or death in light of the meningitis outbreak. If you or a loved one received a steroid injection for back pain between July and September 2012, you should first seek medical attention. Once you have done that, our dedicated pharmaceutical attorneys are available to discuss your legal options. Call us today at 888-616-4339. The call is confidential and toll free.

Researchers have uncovered a possible link between a common drug used to treat diabetes and an increased risk of vision problems, according to a HealthDay report. According to the study, which first appeared in the online edition of the Archives of Internal Medicine, users of thiazolidinediones may be two or three times more at risk of a serious problem with their vision, called macular edema. Macular edema, according to the National Eye Institute, is a condition in which fluid leaks into the macula, or the part of the eye where sharp, straight-ahead vision happens. The fluid then makes this part of the eye swell, which causes blurry vision.

This means more trouble for users of Actos, Avandia and similar drugs, since thiazolidinediones are in both Avandia and Actos, and are used to help control blood sugar in people with diabetes. We’ve written before about the bladder cancer risk linked to Actos, and the HealthDay report mentions the links between Avandia and serious risks of heart problems.

For the study, which was carried out in England, lead researcher Dr. Iskandar Idris and his team looked at data from more than 100,000 people with type 2 diabetes. At the start of the study, none of those 100,000 people had macular edema. After one year, however, diabetes patients in the study who were taking Actos, Avandia, or other thiazolidinediones developed the eye problem more than six times as often as the diabetes patients who didn’t take those drugs.

According to researchers, about 20 percent of people with diabetes suffer from macular edema, which is one sign of a serious vision illness. An editorial that appeared with the study in the Archives of Internal Medicine said that the study adds to a growing concern about the possibility of drugs like Avandia or Actos causing fluid buildup in the eyes of people who use the drugs. Dr. Sonal Singh, who co-wrote the editorial, said diabetes patients who take Avandia or Actos should see an eye doctor promptly if they experience visual symptoms.

Contact Our South Carolina Prescription Drug Injury Lawyers Today
Prescription drug injuries can be very serious. In many cases, medical professionals may not realize that a patient’s illness was caused by a drug, causing them to lose precious treatment time. Indeed, the causes of some prescription drug injuries may not be apparent until months or years later, when independent scientists discover problems with the drug. Some of the most serious injuries caused by recently discredited prescription drugs include heart attacks and myocardial infarction, heightened or lowered blood pressure, blood clots, rapid changes in blood sugar and other potentially fatal conditions.

If you or someone you care about has been injured or killed by an unsafe prescription drug, contact the South Carolina personal injury attorneys at the Louthian Law Firm today. Call toll free at 888-662-9821 or locally at 803-454-1200 or use our online for a free evaluation of your case.

Drug company giant GlaxoSmithKline made U.S. history recently in an agreement with U.S. authorities requiring the company to pay a $3 billion healthcare fraud settlement. The GlaxoSmithKline deal with the U.S. Department of Justice also has the drug maker pleading guilty to three misdemeanor criminal counts.

The criminal counts are linked to three different GlaxoSmithKline drugs: Paxil, Wellbutrin and Avandia.

News about the settlement says that $1 billion will go toward settling criminal complaints leveled against the company, and the other $2 billion will go toward settling civil fines.

A large part of the settlement focuses on attempts by GlaxoSmithKline to get doctors to prescribe certain of its drugs in ‘off-label’ uses. As the American Cancer Society summarizes, an off-label drug use is when “a drug is used in a way that is different from…the FDA-approved drug label..

According to the FDA, the decision to use drugs in an off-label prescription is left up to doctors in most cases. However, while it may be legal for doctors to prescribe drugs for off-label uses, it’s not legal for drug companies to advertise or promote those off-label uses.

According to a Reuters article about the settlement, the Department of Justice says that’s exactly what GlaxoSmithKline did. Some of the off-label uses that U.S. officials say GlaxoSmithKline promoted include prescribing the antidepressant drug Paxil to treat patients under the age of 18 and prescribing the antidepressant drug Wellbutrin for weight loss.

According to the investigation, which the Department of Justice spearheaded, GlaxoSmithKline encouraged doctors to prescribe these drugs off-label to their patients by treating doctors to spa programs, special dinners and other activities.

A different sort of controversy surrounds the charges relating to the diabetes drug Avandia. In the case of Avandia, prosecutors say, GlaxoSmithKline didn’t give important safety information to the Food and Drug Administration. The data, the Department of Justice says, has led to so-called ‘black box’ warnings on Avandia, advising doctors and patients about the increased risk of heart attack and heart failure linked to the drug.

As Reuters coverage of the drug settlements points out, the size of the $3 billion settlement and extent of the criminal charges is a new level of victory for U.S. drug and health regulators. As James Cole, with the U.S. Justice Department said, the GlaxoSmithKline medical fraud settlement is, “a clear warning to any company that chooses to break the law..

About The Louthian Law Firm
The Louthian Law Firm, P.A., of Columbia, S.C., has been obtaining fair compensation for personal injury victims since 1959. The firm was founded by Herbert Louthian, who has more than 50 years of trial experience and is licensed to practice in all courts in South Carolina. The Louthian Law Firm focuses on personal injury cases involving medical malpractice; car, truck and motorcycle accidents; and other serious and catastrophic injuries throughout South Carolina. For a free, confidential case evaluation, contact the firm by phone at 888-662-9820 or through its online form.

It seems medical research linking diabetes drug Actos to bladder cancer just keeps piling up. A new study from Canada, recently published in the Canadian Medical Association Journal, found that the common diabetes treatment may be involved in raising bladder cancer risks for users by as much as 22 percent.

The authors of the new study say that they still aren’t sure how or why pioglitazone, the drug in Actos, is linked with the higher cancer risk. Senior study author Jeffrey A. Johnson says that recent studies of the drug’s effects in animals show that Actos may cause crystals to form, which might then irritate the bladder and trigger the increased cancer risk.

Current studies show that, overall, people with type 2 diabetes have about a 40 percent higher risk of developing bladder cancer than other people. Doctors think this may be because people with this type of diabetes have increased levels of insulin, a chemical produced by the body to help digest food, in their bodies.

According to the National Institutes of Health, diabetes affects 25.8 million people in the U.S., or just over 8 percent of people. Type 2 diabetes is the most common form of diabetes in the U.S., and diabetes is responsible for $116 billion in medical costs in the U.S. each year.

We’ve written before about the growing evidence linking Actos to cancer dangers. The drug in Actos is also a part of diabetes medications sold under the names Actoplus Met, Actoplus Met XR, and Duetact. According to the Food and Drug Administration (FDA), 2.3 million people filled prescriptions for pioglitazone drugs in the first 10 months of 2010.

The findings from the Canadian study reinforce findings by an earlier French study and a five-year study by the FDA, which all found links between the Actos drug and higher risks of bladder cancer. The FDA has said that it will continue to monitor data from patients prescribed diabetes drugs with pioglitazone in them.

According to the FDA, people who’ve taken pioglitazone drugs–whether under the name Actos, or in another form like Duetact–should be aware of the increased bladder cancer risk, as well as potential symptoms of bladder cancer. Symptoms includepain in the lower back and abdomen, the appearance of blood or a red color in urine, pain while urinating, or an urgent need to urinate. Experts still don’t agree about how best to safeguard patients–France suspended the drug, and Germany recommended that doctors not prescribe it for any new diabetes cases. In the U.S., some doctors say they have stopped prescribing the drug. Others say they look at a patient’s overall background and cancer risk, and may still prescribe the drug if the risk of cancer seems low enough. For the millions of American patients taking the pioglitazone drug, however, this new study may just show that the risk is never low enough.

About The Louthian Law Firm
The Louthian Law Firm, P.A., of Columbia, S.C., has been obtaining fair compensation for personal injury victims since 1959. The firm was founded by Herbert Louthian, who has more than 50 years of trial experience and is licensed to practice in all courts in South Carolina. The Louthian Law Firm focuses on personal injury cases involving medical malpractice; car, truck and motorcycle accidents; and other serious and catastrophic injuries throughout South Carolina. For a free, confidential case evaluation, contact the firm by phone at 888-662-9820 or through its online form.

After a five-year study, the U.S. Food and Drug Administration (FDA) recently announced that patients who took certain medications for diabetes may now have a much greater risk of bladder cancer.

According to the FDA safety announcement, those who took the prescription drug pioglitazone, sold under the brand name Actos, may be at risk. The drug is also a part of diabetes medications sold under the names Actoplus Met, Actoplus Met XR, and Duetact. These prescriptions are used most often in the treatment and control of type 2 diabetes in adults.

Also according to the FDA, 2.3 million patients filled prescriptions for medications containing the drug pioglitazone in the first 10 months of 2010. The FDA safety announcement is the result of both the five-year data review by the FDA and a recent study in France, which showed that exposure to pioglitazone increases the risk of bladder cancer over time.

No studies have yet to show a direct link between the drug and bladder cancer, but experts do agree that studies have shown that use of the drug over an extended period of time puts patients at risk. According to the FDA review, patients exposed for a period of 12 months or more had a 40 percent increase in risk of bladder cancer. The French study showed that an increased risk was particularly associated with male patients.

The FDA has said that it will continue to monitor data from patients prescribed diabetes drugs like Actos. France has suspended use of pioglitazone, and Germany has recommended its physicians not prescribe the drug for use in new diabetes patients.

People who are currently taking or have taken diabetes medications containing the drug should be aware of the increased bladder cancer risk, as well as potential symptoms of bladder cancer, according to the FDA. Problems such as pain while urinating, an urgent need to urinate, pain in the lower back and abdomen, or appearance of blood or a red color in urine may indicate the presence of bladder cancer.

The FDA also recommends that patients talk to their doctors about any problems or concerns about diabetes prescription drugs.

The South Carolina prescription drug injury attorneys at Louthian Law Firm are here for you if you or a loved one has suffered life-threatening side effects from Actos or any other drug. Contact us at today at (888) 926-0056, or locally at (803) 454-1200. You can also use our online contact form. We’ll give you a free evaluation of your case.

A former University of Utah football player has filed a product liability lawsuit against the makers of the Stryker pain pump after claiming use of the pump after shoulder surgery resulted in permanent shoulder damage.

The man developed chondrolysis, severe loss of cartilage in the joint, and his lawsuit claims Stryker Corp. should have known about the risk of cartilage problems associated with the use of their pain pumps. The suit claims that the treating doctor would not have used the pump for pain management had he been aware of the risk of chondrolysis.

In 2009 FDA required manufacturers of pain pumps to add warnings about the risk of chondrolysis from shoulder pain pumps. Several other shoulder pain pump lawsuits have been filed claiming chondrolysis-related injuries.

If you have suffered a personal injury or lost a loved one due to a defective product, the attorneys at Louthian Law Firm can help. Call us for a free consultation at 866-454-1200.

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