Archive for October, 2011

Yaz is no miracle

Thursday, October 13th, 2011

Many women experience premenstrual dysphoric disorder (PMDD) that affects their mood and all the people around them.

So when a company claims they produced a miracle birth control that helps with the disorder almost every woman wants to try it. The risks of this birth control fail to outweigh the benefits because of the numerous side effects.

There are numerous warnings associated with the use of YAZ including, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension.

YAZ has additional risks because it contains the progestin, properties which can lead to hyperkalemia in high-risk patients, which may result in potentially serious heart and health problems.

Some side effects include: sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance; chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; a change in the pattern or severity of migraine headaches; stomach pain, loss of appetite, jaundice; a breast lump; or symptoms of depression.

 

Study shows that Vioxx increases heart problems

Tuesday, October 11th, 2011

After a 3-year investigation into the arthritis drug Vioxx, the study revealed an increase of cardiovascular complications after 18 months of use.

FDA Commissioner Dr. Lester M. Crawford stated in a press release that the FDA would closely monitor other drugs in this class for similar side effects. Crawford added, “All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician.”

There are many existing lawsuits filed against Merek, the company producing the drug, and Crawford expects many more. The alternative method for patients diagnosed with arthritis is Celebrex, Bextra, and Arcoxia just to name a few.

Drugmaker announces recall of Topamax

Monday, October 10th, 2011

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced it is voluntarily recalling two lots of TOPAMAX 100mg Tablets.

These two lots were shipped and distributed in the U.S. and Puerto Rico.

While the recall encompasses approximately 57,000 bottles of TOPAMAX, the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA.

TBA, a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored. An internal investigation is underway to evaluate the potential source of this TBA issue.

In addition, the company is working with peer companies to better understand how and where TBA is entering and impacting the supply chains and what can be done to further mitigate this exposure.

Are “drug holidays” a safe recommendation?

Thursday, October 6th, 2011

Since the launch of medications meant to treat osteoporosis over 15 years ago, millions of women began taking prescribed medications meant to treat this disease.

After evidence has been introduced that many of these long term use drugs may do more harm than good, doctors have started suggesting a “drug holiday” to patients.  In other words, patients are being instructed to stop usage of these drugs for a certain period of time.

Dr. Richard Eastell of the American Society for Bone and Mineral Research has stated:  “Worldwide, it’s a commonly discussed question as to how long you should go on with these treatments.  Beyond 10 years, we have no knowledge of how these treatments work.”

In rare cases, drugs used to treat osteoporosis such as Actonel, Fosamax, and Boniva have been linked to jaw necrosis, a condition in which the jawbone begins to deteriorate.   Long term users of these drugs can also develop fractures in the thigh bone (femur).

 

Specialists state that drug holidays may be justified due to the fact that these medications remain in bone tissues for 1-2 years after they are discontinued.

 

Dr. Reid of the University of Auckland in New Zealand says “After 5 years, it’s a good time to reassess.  If the bones don’t show osteoporosis, we typically stop the drug and monitor bone density.  If they still have osteoporosis readings or have a fracture, we keep them on medications for out to 10 years.”

 

Dr. Cosman, clinical director of the National Osteoporosis Foundation, claims that it has been difficult to get people to take the drugs.  She went on to say, “… we need to be clear that a 2-5 year course of these drugs saves fractures, pain, disability and life.  There is just no question about that.”

Metallic hip implants fail at an ‘alarming rate’

Wednesday, October 5th, 2011

Researchers are finding more and more that all metallic hips are causing what doctors refer to as a “biological dead zone”.  In this “dead zone”, strands of tissue stained gray and black along with strips of muscles that no longer contract can be found.

Over a decade ago, some researchers warned that these all metallic hips can shed tiny pieces of metal that posed potential health threats to patients, yet those warning were not heeded and now there is a growing health crisis among hip replacement patients.

Often, patients are bounced from doctor to doctor to diagnose the problem and some doctors do not have the knowledge or the tools to properly diagnose a defective hip implant.

According to an investigative article by the New York Times, the particles that are shed by these hips pose a special threat because “scavenger cells dispatched by the body to neutralize the debris convert it into biologically active metallic ions.  In some patients, a chain reaction begins that can destroy tissue and muscle.”

All metallic hips seem to be failing at a rate three times as high as those replacement hips made of both metal and plastic components.  In the first six months of this year, the FDA received more than 5,000 reports about problems with the all metal hips.

If you or a loved one has been permanently injured by having a hip replacement in which an all metallic hip was used, our lawyers may be able to help.

 

Are the drugs your hospital uses safe?

Tuesday, October 4th, 2011

Everyone wants to believe that if they are admitted to the hospital, the staff is adequately equipped to give you proper care.  That may not be certain today, though.  There is a current shortage on certain drugs leading to the endangerment of patients, disruption of hospital care, and raising the cost of care.

The primary drugs that are in short supply are injectable generic drugs that are ordinarily cheap.  These shortages cause a delay in surgeries and cancer treatments, leave patients in unnecessary pain, and cause hospitals to give less effective treatments, which often results in complications and longer hospital stays.

According to the Associated Press, the shortages could cost hospitals at least $415 million per year.  So far, hospitals have been absorbing the extra costs but they’ll soon have to start passing them on to insurers and patients.

The FDA says the primary cause of the shortages is production shutdowns and manufacturing problems.  Other reasons cited were theft of prescription drugs from warehouses and “gray market” vendors who buy scarce drugs from small regional wholesalers or pharmacies and then sell them to hospitals at many times the normal price.  These “gray market” sellers may not be licensed, authorized distributors.

The average price markup on drugs sold by secondary distributors is 650 percent.  In one extreme case, a vendor was offering a generic beta blocker for dangerously high blood pressure.  The normal price per dose is $25.90, but it was being sold for $1,200 (per dose).

The primary problem with buying stolen drugs is that hospitals can’t always tell whether a medication has been properly refrigerated or is expired.  Using these defective drugs can be dangerous because the active ingredient might have degraded and the drug might not work well or could even harm or kill the patient.

Although the Hospital Association urges hospitals not to buy from unaccredited vendors and to insist on proper documentation of the drug’s source if they must, only three states (Kentucky, Maine, and Texas) have price-gouging laws that specifically cover medicines.