According to new warnings from federal health regulators, the cholesterol drug Trilipix may not reduce the risk of heart attack or stroke, and may actually increase the risk of heart problems among women. Trilipix (fenofibric acid) is an Abbott Laboratories drug approved by the FDA in December 2008. It is supposed to work by lowering “bad” cholesterol and increasing “good” cholesterol. It is often used in combination with cholesterol-lowering drugs like Zocor, known as statins.

Abbott Laboratories, which manufactures the medication, is being required to conduct new clinical trials to measure Trilipix heart effects for patients at high risk of cardiovascular disease, according to the agency.

This came after the FDA analyzed data from a clinical trial known as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The trial compared the safety and efficacy of Trilipix plus Zocor therapy against taking Zocor alone.

The findings of that trial appear to indicate that Trilipix does not decrease the rate of heart attack or stroke on its own, according to the FDA. Also, women appeared to suffer an increased rate of cardiovascular events while on Trilipix.

The FDA is warning patients that the drug has not been shown to lower the risk of heart attack or stroke, and said patients should consult with their primary healthcare provider about the benefits and risks of taking Trilipix.

Several lawsuits have been filed against Merck Pharmaceuticals, manufacturer of Propecia,

Propecia is used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland) and baldness.  The lawsuits accuse Merck of downplaying the risks associated with Propecia and failing to warn patients about the severity of sexual side effects.

The side effects that have plagued men are:  decreased libido, decreased semen output, and depression.  Because so many men feel embarrassment about the side effects of Propecia, scores have chosen to remain anonymous or to not report their conditions.

According to a study published by the Journal of Sexual Medicine in March 2011, drugs in the same class as Propecia are linked to a variety of sexual side effects.  It is possible that they are also linked to an increased risk of the development of breast tissue.

In a separate study in March 2011, the Journal of Sexual Medicine researches reported “men who developed side effects suffered those effects on average for 40 months after discontinuing medication”.

In June 2011, the FDA issued a warning that Propecia could be linked to an increased risk of high-grade prostate cancer.

Preemies are sometimes given steroids known as glucocorticoids after birth to improve lung function and to stabilize low blood pressure. These are common complications of being born prematurely.  “Premature” is defined as being born under 32 weeks of gestation.

A new study conducted at University of British Columbia and University of CA, San Francisco shows that preemies given the steroids hydrocortisone or dexamethasone had on average a 10 percent smaller cerebellum than premature babies who were not given the drugs.

Lead study author Dr. Emily Tam said: “Their cerebellums were growing slower, and we know from other studies that a smaller cerebellum in preemies is associated with poorer outcomes.”  The cerebellum is the area of the brain that is associated with not only motor skills but also learning and behavior.

The American Academy of Pediatrics now recommends avoiding high dose dexamethasone in babies after birth.

The study did not involve those premature babies that were given steroids BEFORE birth.

After being diagnosed with breast cancer, Suzette Fransen Cain and Julius Cain filed suit against Wyeth Company in federal court in New Orleans.

 The lawsuit alleges that Wyeth Co. knowingly made and manufactured hormone replacement drugs which are harmful to patients.

The drugs at issue are Prempro, Premarin, and Provera.  Wyeth is accused of manufacturing hormone therapy drugs that dramatically increase the risk of breast cancer, ovarian cancer, strokes, blood clots and cardiovascular disease.

Cain was prescribed Prempro for over eight years. She was subsequently diagnosed with breast cancer in late 2010 and has undergone a mastectomy and extensive treatment.

The defendants are accused of wrongdoing on several levels including providing an unreasonably dangerous product, unfair and deceptive trade practices, unjust enrichment, manufacturing a product with redhibitory defects, intentional misrepresentation or fraud, negligently misrepresentation and negligent infliction of emotional distress.

Cain is asking for more than $10 million in damages for loss of earnings, medical expenses, loss of earning capacity, pain and suffering, mental anguish, disability, loss of enjoyment of life, loss of consortium, court costs, interest and attorney’s fees.

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.

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.”

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.

Lexapro is prescribed to treat patients with depression and generalized anxiety disorder. However, the drug is not without its problems. The FDA has issued two alerts concerning injuries caused by Lexapro.

The first alert is that Lexapro has been known to cause persistent pulmonary hypertension (PPHT) in babies whose mothers used the drug during pregnancy.

Babies with PPHT have an inadequate blood supply to the lungs which causes oxygen depleted blood to return to the heart. Although some infants can recover quickly, others can have complications and require care throughout the rest of their lives. Statistics show that if the mother was on Lexapro while pregnant they are six times more likely to have a child with a birth defect.

The second FDA alert is regarding serotonin syndrome. Serotonin controls moods, emotions, sleep cycles and appetite. Some drugs like Lexapro can contribute to having too high of levels of serotonin in your body.

Serotonin syndrome can be fatal. Symptoms of this syndrome may include: restlessness, increased heart beat, loss of coordination, nausea, vomiting, tremor, muscle spasms, and several others.

If you believe you have suffered injury by taking Lexapro please call one of our defective drug attorneys today. You may have a case against the makers of Lexapro.

As Americans in today’s society expectations of complete trust and safety are given to doctors when prescriptions are written after a diagnoses. Many never hesitate to ask why they prescribe this new prescription and only hope the judgment in the health decisions will be for the better.

As a woman entering motherhood our hopes and dreams for a healthy baby are conscience on our mind; questioning everything put in our bodies only to ensure the unborn baby is equipped with the best start possible. The OBGYN becomes the best friend and closest confidant during pregnancies. When an expecting mother is forced to take a medication due to the possibilities of preterm labor and the risks outweigh the side effects of the drug, that woman trusts her doctor and hopes only for the best.

Most OBGYNs diagnose preterm labor with a tocolitic medication; Tocolytics are medicines that attempt to stop labor. They are used if labor begins before term.

Tocolytics can stop labor or delay labor to give the baby’s lungs time to mature. When taking this medication, you may need hospitalization or home therapy. Even more worrisome than giving birth pre-term are the risks tocolitics may cause.

Terbutaline, also known as Brethaire, Brethine, and Bricanyl is often used as a tocolitic remedy. Terbutaline sulfate Brethine is said to be generally safe for women who are pregnant. In previous animal studies involving terbutaline and pregnancy, the drug did not cause any problems. Making this drug a category B classification by the FDA regulation. Pregnancy Category B is given to medicines that have not been studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.  Yet, maternal deaths have occurred due to terbutaline use during pregnancies.

Some of the side effects include nervousness, restlessness, insomnia, headache, rapid heart rate, nausea, hyperglycemia (high blood sugar) and hypokalemia (low blood potassium). A rare but serious side effect is pulmonary edema. The side effects are identical in the mother and unborn born baby because the drug crosses the placenta. The mother and baby should be monitored while taking this drug.

In one review of 8,709 patients only 47 had one or more cardiopulmonary problems. Pulmonary edema was reported in 28 patients, 17 of whom had been treated concurrently with large amounts of IV fluids or tocolytic agents and four of whom had been diagnosed with pregnancy-induced hypertension and preterm labor symptoms.

Other cardiovascular effects occurred in 19 patients, including electrocardiogram changes, irregular heart rate, chest pain, or shortness of breathe.

Duke University studied the risks of terbutaline in infants; they found an increased risk of brain damage and cognitive deficits in babies whose mothers were treated with terbutaline during preterm labor. The study showed that the use of terbutaline might predispose babies to autism and other toxins.

Proving the drug caused autism creates debate but fraternal twins may scientifically prove this concept. Fraternal twins are two separate eggs fertilized by two separate sperm to form two separate embryos and then make two separate babies.

Fraternal twins are no more genetically alike than other siblings in the family. Finding fraternal twin pairs in whom both twins have autism spectrum disorders is the key finding that puts a spotlight on the use of terbutaline during pregnancy.

How can the FDA classify this drug as a category B when statistically deaths and birth defects clearly correlate with the use of this medication? How can the FDA warn doctors of the side effects but allow them to prescribe this medication as an off-label remedy. Furthermore, why do doctors continually prescribe this medication to expecting mothers knowing the risks that may occur?

As a woman expecting prayer and hope for perfect health is a daily process.

Expertise and trust within the doctor help suppress any negative thoughts but at the end of the day reality proves each patient is simply another number.

For the better part of a decade, a factory in Puerto Rico produced potentially faulty and contaminated drugs for British drug maker GlaxoSmithKline.

This week, the drug maker said that it has reached a $40.75 million settlement with 37 states and the District of Columbia under their consumer protection laws following a $750 million criminal and civil settlement with the federal government last October.

Both settlements involve manufacture of substandard medicines made from 2001 through 2004 at a factory in Cidra, Puerto Rico. The poorly manufactured drugs include included Paxil CR, a blockbuster antidepressant that has since gotten generic competition, plus anti-infection ointment Bactroban, sterile anti-nausea medication Kytril and Avandamet, a diabetes drug.

The case was brought after a company whistleblower reported on conditions in the factory to the Food and Drug Administration. The whistle-blower had already reported many other violations to her bosses, including a contaminated water system and an air system that allowed for cross-contamination between different products being made there. She said she was fired in 2003 after repeatedly reporting the problems to the company.

GlaxoSmithKline admitted no wrongdoing.

Products made at the Puerto Rico plant have all been recalled or are past their expiration dates.

Source: the Associated Press