According to a Fox news report, more people die in America every year from prescription drug abuse than die from heroin and cocaine combined.  This leads us to the questions:

1. Are doctors over prescribing?
2. Are doctors closely monitoring drug usage of patients?
3. Are people illegally obtaining prescription drugs?

According to the Centers for Disease Control, most people who die from prescription drug overdose are taking someone else’s medicines, medicines that we left in the medicine cabinet, medicines that were given to a friend or a relative, maybe innocently, maybe maliciously.

In a study done by the CDC it was found that enough narcotics are prescribed every year to medicate each and every adult in America every day for a month.

Thomas Frieden, Director of the CDC, has said “It’s astonishing.  When I went to medical school, we were incorrectly assured, don’t worry, if patients have short-term pain, they won’t get hooked.  That was completely wrong, and a generation of doctors, patients, and families have learned that’s a tragic mistake.”

Although many states have passed new laws to monitor the prescribing of narcotic painkillers, the death rate due to this issue remains high.

A Sheriff of Pinella County in Florida, calls this issue widespread.  “This problem crosses all walks of life, crosses all socio-economic classes.  Crosses all races and gender, national origin, and age”, he said.

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.”

Terbutaline is a drug often given to pregnant mothers to delay delivery.

When it is given during the gestation period, it can cause certain transmitters in the brain to become over stimulated. This excessive stimulation can result in a condition called nueroinflammation, which can be very damaging to the brains’ development.

The neuroinflammation can be enough to scare a family but what if terbutaline made your child more susceptible to environmental pollutants so that simple raw foods like fruits and veggies from the grocery store made them ill?

Researchers found that Terbutaline may contribute to autism spectrum disorder by making the brain abnormally venerable to environmental pollutants and pesticides.

While the actual cause of autism is unknown, many researchers believe the environment’s negative factors contribute immensely.

Educating yourself on the risks and benefits of terbutaline or any other substance can change the outcome of your child health.

Manufacturing problems dogging Johnson & Johnson since 2009 still have not been solved. The company announced yet another drug recall because of musty odors — this time involving branded and generic forms of risperidone, the antipsychotic drug.

MedPage Today is reporting that the company’s Ortho-McNeil-Janssen subsidiary voluntarily recalled certain lost of the drug. The recall is for one lot of 3 mg Risperdal in 60-tablet bottles, lot number 0GG904, expiration May 2012, and of one lot of generic risperidone in a 2 mg dosage, lot number OIG175, sold by Patriot Pharmaceuticals.

As with several previous recalls — including the Tylenol brand of acetaminophen, Benadryl allergy medications, and topiramate (Topamax) — the company said in a statement that it had received reports from patients that the risperidone products emitted “an uncharacteristic odor.”

The two affected lots total about 40,000 bottles of risperidone.

The company advised patients with medications from these lots not to stop taking the medication. However, if they notice unusual odors, they should return the tablets to their pharmacist.

The odor in all these recalls appears to stem from a chemical preservative, 2,4,6-tribromoanisole (TBA), in wooden pallets used in shipment and storage.

No serious adverse events have been reported with the affected risperidone lots. However, according to Ortho-McNeil-Janssen, “a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.”

Source: John Gever, MedPage Today

Johnson & Johnson’s troubles just get more and more stinky.

According to CNN, the pharmaceutical giant announced on Thursday a recall of 57,000 bottles of the prescription anti-seizure medication Topamax following consumer complaints of an “uncharacteristic odor.”
Johnson & Johnson said the recall represents two lots of the Topamax 100 mg tablets made by its Ortho-McNeil Neurologics division.

The affected drugs were shipped and distributed between Oct. 19, 2010 and Dec. 28, 2010 in the United States and Puerto Rico.

The company said it believes fewer than 6,000 bottles of the medicine remain in the marketplace to be recalled. However, Ortho-McNeil Neurologics said it does not anticipate a product shortage resulting from the recall.

J&J said it initiated the recall after receiving four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

The drug is already under fire because it has been linked to oral birth defects in infants who were exposed when their mothers took it.

Last month, the government announced it was taking over three Tylenol plants operated by McNeil following a wave of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

While not considered to be toxic, J&J said TBA can generate an offensive odor, and a very small number of patients have reported temporary gastrointestinal symptoms.

Source: CNN Money

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.

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

The Food and Drug Administration has seized several plants belonging to the drug manufacturer Caraco Pharmaceutical Laboratories Ltd. for manufacturing violations.

The FDA cited multiple violations of manufacturing standards and seized approximately 33 different generic drugs at three different plants. The FDA will prevent Caraco from distributing anything until they have assurance that the company will comply with FDA standards in the future.

The drugs that were seized were generic forms of heart, pain, and psychiatric medicines. Caraco was accused of poor handling of drug ingredients and varying tablet-manufacturing processes.

People currently taking drugs made by Caraco should not be concerned and should continue to take their medications as prescribed. Any defective drugs should have been weeded out of the market already by recalls.

The seizure of these drugs could cause a shortage of choline magnesium trisalicylate oral tablets. If you are currently taking this medication and experience a supply shortage in your area, talk to your doctor about an alternative drug.