Selective Serotonin Reuptake Inhibitors (SSRIs) are types of antidepressants. Brand names of SSRIs include: Paxil, Zoloft, Celexa, Prozac, Lexapro, Symbyax, Wellbutrin and Effexor. These drugs inhibit neuronal serotonin and norepinephrine reuptake and slightly inhibit dopamine reuptake. SSRIs have been associated with serious, life-threatening birth defects. Research suggests that, if a mother took SSRI’s during pregnancy, [...]
SC AG Files Lawsuit Against GSK for Improper Marketing of Diabetes Drug
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Drug Regulators in the US and Europe Restrict Use of Avandia (rosiglitazone)
September 23, 2010
NHTSA Raises Number of Deaths Associated with Toyota Acceleration
May 26, 2010
Toyota Pays $16.4 Million Fine
May 19, 2010
Toyota Announces Plan to Replace Accelerators in Secondary Recall
March 23, 2010
Federal Prosecutors Investigate Glaxo’s Avandia
The Associated Press (10/22, Perrone) reported that GlaxoSmithKline (GSK) is now under investigation by federal and state law enforcement officials in the United States for its diabetes drug, Avandia. Subpoenas were issued by the Department of Justice to investigate the development and marketing of Avandia. This follows the September 23, 2010 restriction by the FDA on the use of Avandia because of its links to heart attacks.
DePuy Orthopaedics ASR Hip Replacement Recall
A DePuy Orthopaedics (Subsidiary of Johnson & Johnson) ASR hip replacement recall was issued for two DePuy Orthopaedics hip replacement products:
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the ASR Hip Resurfacing System
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the ASR XL Acetabular System
after data indicated that 12% (one in eight patients) may fail within five years, requiring painful revision hip replacement surgery.
The DePuy ASR Hip Implant System is a metal-on-metal design, which is viewed as less than optimal because, in time, the metal parts can wear, causing small particles of metal to shed into the body. This metal ion release damages tissue, causes pseudotumors and results in osteolysis, requiring hip revision surgery to remove and replace the DePuy ASR hip device. This may happen shortly after the DePuy ASR hip replacement is implanted, or it may take years to occur.
Symptoms include pain, swelling and problems walking. The recall followed concern of orthopedic experts indicating that a design flaw in the DePuy ASR hip replacement increases the risk of complications such as unexplained hip pain, thigh or groin pain, swelling around the hip, pain in standing up from a seated position, pain with weight bearing and pain with walking.
Adverse Event Reports submitted to the FDA mention instances of loosening, pseudotumor and metalosis. Each of the metal hip replacement products are meant to restore worn or weakened parts of the hip, more specifically, the socket at the outer portion of the pelvis and the rounded bone on top of the thigh bone that fits into the socket. Both ASR products have been implanted in the United States since 2005 and have now been discontinued by DePuy Orthopaedics.
Please note that explanted DePuy ASR hip replacement devices are valuable evidence. A patient may not be able to prove a defective product case without it. Patients should be aware of this and should not sign any documents for DePuy Orthopaedics without first consulting an attorney.
If you or a family member received a DePuy ASR Hip Replacment and had to undergo revision surgery or notice any symptoms, you may have a claim against DePuy Orthopaedics (a subsidiary of Johnson & Johnson).
One of our experienced pharmaceutical attorneys would be pleased to assist you in seeking legal remedies. Please complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.
FDA Warns That Bone Drugs (Bisphosphonates) May Cause Fractures
The FDA warned that a class of osteoporosis drugs (Bisphosphonates) appears to increase the risk of bone fracture. The bisphosphonates affected by this notice are Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia and Reclast and their generic products. FDA Safety Announcement 10.13.10
Bisphonates are a class of medications that may be effective in preventing or slowing the loss of bone mass (osteoporosis) in postmenopausal women, reducing the risk of bone fracture. Although it is not clear if bisphosphonates are the cause, unusual femur fractures have been predominantly reported in patients taking bisphosphonates.
The FDA has required that information be added to the Warnings and Precautions section of the labeling. Bisphosphonate labels will indicate that taking these medications can lead to rare fractures of the thigh bone known as subtrochanteric and diaphyseal femur fractures. If users of bisphosphonates experience new hip or thigh pain (described as dull or aching pain), the labeling recommends that they immediately follow up with their healthcare professional(s).
The FDA notice indicates that a medication guide describing the symptoms of atypical femur fracture will now be required to be given to patients when they pick up their bisphosphonate prescription.
If you or a family member took Bisphonates (Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia and Reclast or their generic products) to prevent bone loss or osteoporosis and suffered from an atypical subtrochanteric and diaphyseal femur fracture (thigh and/or femur fracture), you may have a claim against the manufacturer of the drug.
One of our experienced pharmaceutical attorneys would be pleased to assist you in seeking legal remedies. Please complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.
Meridia (sibutramine) Withdrawn Due to Risk of Serious Cardiovascular Events
October 8, 2010. The FDA issued a News Release stating that Abbott Laboratories agreed to withdraw its obesity drug Meridia (sibutramine) from the US market because of clinical trial data that indicated an increased risk of heart attack and stroke. Meridia FDA Press Release
Abbott’s withdrawal followed the FDA’s recommendation for physicians to stop prescribing Meridia for their patients. The FDA also recommended that patients talk to their healthcare provider about alternative weight loss and weight loss maintenance programs. Meridia Safety Alert
Meridia was approved by the FDA in November 1997 to be used for weight loss and maintenance of weight loss in obese and overweight people who had other risks for heart disease. The FDA’s approval was based on clinical data showing that more individuals who took Meridia (sibutramine) lost at least 5 percent of their body weight than those who took a placebo and relied on diet and exercise.
The Sibutramine Cardiovascular Outcomes Trial (SCOUT) conducted recently demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients who took Meridia (sibutramine) compared with those who were given a placebo. In addition, there was a small difference in weight loss between the two groups.
If you or a family member took Meridia (sibutramine) for weight loss or weight loss maintenance and suffered a heart attack, stroke or death, you may have a claim against Abbott Laboratories.
One of our experienced pharmaceutical attorneys would be pleased to assist you in seeking legal remedies. Please complete the short form below or call us at 1-800-642-5297 for a free, confidential consultation at a time convenient for you.