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.”

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.

After more than 50 product recalls in 15 months, including for artificial hips and Tylenol, the $60 billion company is fighting to clear its once-trusted name.

The recalls — voluntary and otherwise — reads like your family medicine cabinet: Tylenol and St. Joseph Aspirin were recalled for foul odors people said made them sick; Benadryl and Zyrtec were recalled for botched amounts of ingredients; Rolaids were recalled for containing bits of wood and metal.

Over the last 15 months, the company has recalled contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world.

In the year ended Mar. 8, 2011, J&J was involved in at least 11 major recalls, as defined by the FDA, almost twice as many as Pfizer (PFE), the world’s largest health-care-products company by revenue, or Procter & Gamble (PG), the world’s largest consumer-products company.

J&J’s woes aren’t confined to the last couple of years. During the last decade, the company has been repeatedly confronted with claims that it sold a product that was defective, or that carried risks J&J downplayed in its marketing. It has been accused of paying kickbacks and using other financial incentives to promote off-label use of drugs and devices. It has been cited by federal authorities for trying to avoid the publicity of a recall by quietly buying up tainted products. And it frustrated FDA regulators who were urging the company to strengthen quality control at the factories that produced many of the recalled over-the-counter products.

J&J has steadfastly denied these claims, but its own annual report for 2010 contains eight pages detailing government criminal and civil investigations and thousands of private lawsuits covering a wide range of drugs, devices, and business practices.

If you’ve haven’t been keeping up, here is a recap of the recalls in just the last couple of years.

Johnson & Johnson’s recall rap sheet:

• AUG 2008: Consultants to J&J buy defective Motrin from stores. The FDA says it wasn’t notified of this “phantom recall.”
• NOV 2009: McNeil pulls about 6.3 million bottles of tainted Tylenol Arthritis Pain caplets made in Puerto Rico.
• JAN 2010: McNeil expands withdrawal to include Benadryl Allergy, Tylenol, Children’s Tylenol Meltaway, and Rolaids.
• APR 2010: J&J recalls 135 million bottles of meds made in Fort Washington, Pa., and closes the plant.
• MAY 2010: The FDA says the U.S. may pursue criminal charges against J&J.
• JUNE 2010: McNeil expands the recall from its Puerto Rico plant to include five more lots of Benadryl and Tylenol.
• JULY 2010: Yet more recalls; company submits remediation plan for McNeil plants to FDA.
• AUG 2010: Company appoints quality-control czar, announces corporation-wide standards.
• AUG 2010: J&J pulls 100,000 boxes of 1-Day Acuvue TruEye contact lenses; days later, DePuy recalls ASR hips.
• DEC 2010: 13 million packages of Rolaids softchews are recalled after customers find wood and metal particles in them.
• JAN 2011: J&J withdraws 43 million bottles of Rolaids, Tylenol, Benadryl, and Sinutab.
• JAN 2011: J&J announces 2010 earnings, puts lost sales from recalls and plant slowdowns at $900 million.
• FEB 2011: J&J units announce recalls of 70,000 potentially cracked syringes preloaded with the antipsychotic Invega.
• MAR 2011: J&J withdraws 585,000 surgical sutures due to concerns about compromised sterile packaging.
• MAR 2011: J&J’s Animas unit announces recall of 384,000 insulin-pump cartridges that may leak.
• MAR 2011: FDA and McNeil announce consent decree that will give agency expanded oversight of three plants.

Topiramate (brand name: Topamax) is used to treat epileptic seizures and prevent migraines. However, the drug presents a risk of  birth defects in children born to mothers taking the drug.

As a result, the FDA has required that Topamax carry a stronger warning to alert pregnant women of the risks regarding taking the drug while pregnant.

According to the research, infants who were exposed to Topamax during pregnancy, specifically the first trimester, had an increased risk of developing cleft lips or cleft palates. If you took topiramate during pregnancy and delivered a child with an oral birth defect, you may be entitled to monetary damages.

Topamax Pregnancy Guidelines
Topiramate (brand name: Topamax) presents a risk of birth defects in children born to mothers taking the drug. As a result of this risk, the FDA released new Topamax pregnancy guidelines:

• Women of childbearing age should speak with their doctors about alternate treatment options, to limit the use of Topiramate during pregnancy
• Women of childbearing age who continue treatment with Topamax should use an effective birth control method
• Before beginning Topamax, women should speak with their doctor if they are pregnant or plan to become pregnant
• Women who become pregnant while taking Topamax should speak with their doctor immediately
• Women, even those who are pregnant, should not stop treatment with the drug before speaking with their health care professional

Due to the recent information regarding Topamax and pregnancy, women who took Topiramate during pregnancy and delivered a child with a cleft palate or cleft lip may have legal recourse. A Topamax lawsuit would allow women the opportunity to recover the cost of medical bills and other damages resulting from their child’s Topamax birth defects. To find out if you can participate in a Topamax lawsuit, complete our no cost case review form with details of your Topamax pregnancy side effects.

Posted on behalf of Cappolino Dodd Krebs LLP.

That pharmaceutical companies occasionally manufacture a dangerous drug or that a defective drug slips through the system isn’t really news.

We’ve known for some time that there were serious problems with dangerous drugs like Paxil and Avandia.

Now, we’re learning that GlaxoSmithKline, a British drug giant, has agreed to pay $750 million to settle criminal and civil complaints that the company for years knowingly sold contaminated baby ointment and an ineffective antidepressant made in their Puerto Rico plant, despite warnings from their own quality control manager that the plant had problems.

Cheryl D. Eckard, GlaxoSmithKline’s quality manager, asserted in her whistle-blower suit that she had warned of the problems but the company fired her instead of addressing them. Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug. No patients were known to have been sickened, although such cases would be difficult to trace.

In a rising wave, recent lawsuits have asserted that drug makers misled patients and defrauded federal and state governments that, through Medicare and Medicaid, pay for much of health care.

Ms. Eckard’s role in the case began in August 2002 when GlaxoSmithKline sent her to Cidra, south of San Juan, to lead a team of 100 quality experts to fix problems cited by an F.D.A. warning letter a month earlier.

This was GlaxoSmithKline’s premier manufacturing facility, producing $5.5 billion of product each year. But Ms. Eckard soon discovered that quality control was a mess: the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles.

Although F.D.A. inspectors had spotted some problems, most were missed. And the company abandoned even the limited fixes it promised to conduct, the unsealed lawsuit says. Ms. Eckard complained repeatedly to senior managers; little was done. She recommended recalls of defective products; recalls were not authorized. In May 2003, she was terminated as a “redundancy.”

She complained to top company executives, but she was ignored even after warning that she would call the F.D.A. So she called the F.D.A. and sued. The agency began a criminal investigation and used armed federal marshals in 2005 to seize nearly $2 billion worth of products, the largest such seizure in history. Unable to fix the plant, GlaxoSmithKline closed it in 2009.

If you or someone you love has been harmed by one of these defective drugs, you may be entitled to financial compensation. Please contact an experienced defective drugs attorney for professional insight.

Source: GARDINER HARRIS and DUFF WILSON of The New York Times.

Agency working with trade associations to increase company vigilance and protect public

In a letter sent to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

The FDA has noted the three most common categories of these illegal products:

* Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).
* Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
* Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration in September announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.

These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
 
Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.
 
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly. 
 
“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

If you or a loved one has been injured as the result of taking a dangerous drug, seek out an experienced defective drug attorney for professional insight.
 
Source: U.S. Food & Drug Administration

An article in the January 2011 issue of “Vanity Fair” details the globalization of our nation’s pharmaceutical trials.

As recently as 1990, the vast majority of drug trials were conducted in the U.S. or Europe. Today, pharmaceutical companies conduct most of their human testing in India, Africa and China.

It’s a lot cheaper and there are fewer regulations these companies much follow — in fact, in many of these countries, nothing regulates drug experiments on humans.

Further, there is absolutely nothing that demands transparency for these trials which lets drug makers pick and choose which trials they use to apply to the U.S. Food and Drug Administration for permission to market drugs in this country.

The FDA depends heavily on these trials. Because our enforcement mechanisms are so dangerously thing — as demonstrated in the heparin scandal — the FDA has precious little ability to oversee drug trials in this country, much less the more than 6,485 trials conducted overseas (in 2008).

Many of the drugs that are currently facing harsh criticism are the very drugs that relied heavily on these overseas trials. Studies for drugs like Celebrex, Ketek, Seroquel, Avandia and Paxil were conducted overseas, and the results of those trials — usually only the trials that showed the drug in the most positive light — used to gain FDA approval.

Often, these drug companies test drugs on children, even when their own researchers insist that the drug will have a limited benefit. Western countries have rigid regulations about testing on children but these regulations do not exists in most third world countries. Parents of these children — who are often illiterate and quite poor — are paid $350 per child enrolled in these studies but seldom told that they were taking part in an experiment.

The article makes the point that drug makers really do put profit first, and have only passing regard for the lives affected by the dangerous and defective drugs they make.

The article cites on study which revealed that, in 2009, 19,551 people died as a direct result of the prescription drugs they took, and that is just the reported number; only about 10 percent of such deaths are reported.

This puts the number of deaths due to FDA-approved drugs near 200,000 — dwarfing the number of people who die every year in car wrecks.

If you or someone you love has been harmed from using a dangerous or defective drug, please contact an experienced defective drug attorney for professional insight.

According to a recent study, DES (diethylstilbestrol) may increase breast cancer risks for DES Daughters, as well as their mothers.

DES, a synthetic form of estrogen, was widely prescribed to prevent premature delivery and miscarriage. However, when given during the first five months of a pregnancy, DES could interfere with the development of the reproductive system in a an unborn child.

Between 5 and 10 million pregnant women were treated with the drug from 1938 to 1971. Studies conducted in the 1950s showed the drug was not all that effective in preventing complications of pregnancy so its use declined — but did not completely stop — until 1971.

A recent study provides initial results linking exposure to DES before birth with increased rates of breast cancer.  The study found that among participants, DES Daughters were more likely to experience breast cancer than were unexposed women.

Further, the study did find that, in women over 40 years old, DES Daughters were two-and-a-half times more likely than unexposed women to be diagnosed with breast cancer.

According to the National Cancer Institute, 16 percent of women prescribed DES during pregnancy developed breast cancer, in comparison with 13 percent of women not prescribed DES. Therefore, it is estimated that one in six women who were prescribed DES will develop breast cancer, whereas one in eight women in the general population will develop the disease.

The drug used for cosmetic purposes and some muscle spasms known as Botox has received criticism for inadequate warnings about off-label uses.

The FDA-approved drug uses a toxin known as botulinium toxin type-A to remove facial wrinkles, relief of excessive sweating, and treatment for cervical dystonia and other facial muscle spasms. The toxin paralyzes the targeted muscles or nerves for an average three to four months.

If improperly used, the toxin (which is essentially the same bacterium that causes botulism) can spread throughout the body, causing muscle weakness, difficulty breathing, blurry vision, bladder control, and even death.

Another concern is the use of Botox to control muscle spasticity in children, including those with cerebral palsy. The FDA has not approved the use of Botox for that purpose; several injuries have been reported as a result of this off-label use.