Author Archives: Brenda Fulmer

Drug Watch: Zimmer Knee Implants Plagued With Failure

Knee implants you thought would last decades may only last 3 years.

Zimmer is an international medical device manufacturer based in northern Indiana. It was founded in 1927, and focuses on the manufacture of products for orthopaedic surgeries. Zimmer’s sales in 2009 were $1.76 billion, and it is estimated that the NexGen family of knee implants make up about 2% of the overall sales of Zimmer.

Flex implants are not lasting nearly as long as intended.

The Zimmer NexGen Knee Implant is not a specific device, but rather a family of devices. Within this NexGen device family, there are different models of implants: NexGen CR-Flex, NexGen LPS-Flex, NexGen High Flex, NexGen LPS, NexGen MIS.

Unlike most knee implants, the Zimmer NexGen CR-Flex is attached without the use of cement, which may cause the system to loosen or detach completely.

The Zimmer NexGen CR-Flex implant was designed to give patients better range of motion than the customary NexGen device. Scientific studies have been accumulating for years with regard to concerns over the safety of the NexGen CR-Flex. Interestingly, the U.S. Continue reading →

Prior results do not guarantee outcomes.
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What Expecting Parents Need To Know About Topamax


Topamax has been linked to an increased risk of birth defects

Topamax, also known as topiramate, was originally approved by the Food & Drug Administration (FDA) for the treatment of seizures in epileptic patients. However, it is often prescribed “off-label” for weight loss, chronic pain, headaches, alcoholism, bulimia, and psychiatric conditions. Off-label use of medications is controversial, but not illegal. A drug company is only permitted to market its drugs for uses that are part of the warning label and for indications for which the FDA has approved the drug after reviewing available safety data. Many pharmaceutical manufacturers, however, have faced civil and criminal penalties over the last decade for also promoting their drugs for uses for which they have not been approved by the FDA and for which they have failed to provide adequate safety information. Many physicians are unaware of the lack of safety data to support a number of off-label uses of medications, which has resulted in harm to patients.

Recently, Topamax has been linked to birth defects in children. Continue reading →

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Drug Watch: Safety Concerns Over Multaq Continue to Rise

MultaqMultaq (also known as dronedarone) was approved by the Food & Drug Administration (“FDA”) in July of 2009 as an anti-arrhythmic drug for use in heart patients with persistent atrial fibrillation, which is the most common cardiac arrhythmia (abnormal heart rhythm), or paroxysmal (irregular heart rhythm). The drug is manufactured and marketed by Sanofi-Aventis. Multaq carries a “black box warning” which is the strongest level of warning on a prescription drug. The warning informs physicians that Multaq should not be prescribed for patients with severe congestive heart failure due to concerns that use of the drug might worsen patients’ heart failure symptoms or increase their chance of dying.

In the few short years that Multaq has been sold by Sanofi-Aventis, the heart drug has been in the news quite a bit, but not because of its wonderful benefits for patients. Instead, there is growing evidence that the drug is dangerous which has led to a great deal of fear for patients and apprehension among prescribing physicians:

• Early 2010 – The FDA warned of possible problems with the development of congestive heart failure in patients taking Multaq.

• Spring 2010 – The FDA warned of a possible link between Multaq and a potentially fatal Continue reading →

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Drug Watch: Statins Can Cause Muscle Damage

Statins (also known as HMG-CoA reductase inhibitors) are a class of drugs used to lower cholesterol levels. Increased cholesterol levels have been associated with cardiovascular diseases, and statins are used in the prevention and treatment of these diseases.

As of 2010, the names of statins on the market were as follows:

Many patients take generic rather than brand name versions of these drugs, and a number of newer statin medications are actually combination drugs that include a statin plus another medication.

Approximately 5 to 10 percent of patients who take statins have experienced muscle aches and pains that are caused by the drug, but just put it down to “growing older.”

Approximately 5 to 10 percent of patients who take statins have experienced muscle aches and pains that are caused by the drug, but just put it down to “growing older.” A recent survey of such people who said they experienced these and other side effects noted that they had attempted to speak with their doctors about these side effects, but found that overwhelmingly (87 percent of the time), their doctors ignored or dismissed their concerns. The FDA has warned that taking the maximum recommended dose of 80 mg of simvastatin (Zocor and generic) could cause muscle damage. The statin drug Baycol (also known as cerivastatin) was recalled in 2001 due to muscle toxicity.

High doses of statin drugs have been linked to an increased risk of a life-threatening form of muscle breakdown called rhabdomyolysis, which can lead to permanent kidney damage, coma and even death. When Baycol was recalled, it was noted that it was 8-times more likely to cause rhabdomyolysis than other statins on the market. There have been concerns for many years that patients who take Crestor Continue reading →

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Drug Watch: Yaz & Yasmin’s Misleading Ads and Dangerous Side Effects

Yaz and Yasmin put women at a higher risk for potentially lethal side effects than other birth control pills.

Yaz, Yasmin and Ocella (Generic Yasmin) birth control have made billions of dollars for Bayer and Berlex, who have advertised the oral contraceptives not only for birth control, but also as a cure to acne and premenstrual problems. Tragically, thousands of young women have paid the ultimate price with lethal side effects ranging from blood clots to heart attack, gallbladder injuries and sudden cardiac death.

Tragically, thousands of young women have paid the ultimate price with lethal side effects

Medical experts believe that safety issues relating to blood clots may have surfaced as early as 2001 in the clinical trials for Yasmin. Recent evidence suggests that Berlex, the drug’s original manufacturer, and its successor, Bayer, knew as early as 2003 that users of Yasmin faced twice the risk of suffering blood clots as patients using competing products. Yet, the companies invested millions in advertising, Continue reading →

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Drug Watch: Osteoporosis Drugs Are Giving Women Severe Complications

Bone health drugs like Actonel, Aredia, and Boniva may cause severe complications.

Post-menopausal women welcomed the class of drugs called “bisphosphonates,” which purportedly increase bone density by slowing the body’s natural turnover of bone cells and were touted as a safe and effective treatment for osteoporosis and osteopenia.

Bisphosphonates are also widely used to treat both male and female patients whose cancer has spread to their bones and by patients who have a progressive bone disease called Paget’s disease.

Many patients who are being prescribed “bisphosphonates” for the treatment and prevention of osteoporosis are unaware of any risks associated with the use of such drugs.

Popular bisphosphonate drugs and their manufacturers include:

Fosamax is also available as the generic drug, alendronate. The drugs are available as pills as well as injections, and may be taken daily, several times per week, monthly, or event annually.

Patients who took these popular osteoporosis drugs have suffered severe bone fractures due to a weakening in bone structures caused by the drugs.

 

In a sad irony, patients who took these popular osteoporosis drugs in hopes of improving
their bone health have actually suffered severe bone fractures, such as atypical femur
fractures, due to a weakening in bone structures caused by the drugs.

In addition, these bisphosphonate drugs have been linked with Continue reading →

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