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Recent Blog Posts in September 2010 |
| September 15, 2010 |
| Experts Recognize Possible Link Between Thigh-Bone Fractures and Long-Term Fosamax Use |
| Posted By DeCarli Law |
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An expert panel announced yesterday that long-term use of Fosamax and other osteoporosis drugs may be related to serious fractures of the thigh bone. Fosamax is one of a class of drugs called bisphosphonates.
The expert task force was convened by the American Society of Bone and Mineral Research, the leading scientific organization on bone science, to investigate the link between bisphosphonates and unusual femur fractures. Of 310 cases of “atypical femur factures,” 94% had taken bisphosphonates for more than five years.
The task force’s report called for better product labeling, along with further research to confirm whether and how bisphosphonates cause femur fractures. In addition to Fosamax, bisphosphonates include Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, Fosavance, Reclast, Skelid, and Zometa.
Importantly, the report states that there are often warning signs before the fractures occur. More than half of the patients with fractures reported groin or thigh pain for weeks or months before the facture.
If you or someone you love is a long-term user of Fosamax or another type of bisphosphonate and are experiencing groin or thigh pain, contact your physician immediately.
The task force press release may be found HERE.
The task force’s complete report, “Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research,” may be found HERE. |
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| September 13, 2010 |
| Recalled Diet Drug Solo Slim Contains Synephrine |
| Posted By DeCarli Law |
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The FDA recently ordered the recall of diet drug Solo Slim because it contains an undeclared drug ingredient, Didesmethyl Sibutramine, a risk for people with a history of heart disease. However, Solo Slim also contains Synephrine, another potentially dangerous drug that can cause heart attacks, heart palpitations, strokes, and even death.
Synephrine (or oxydrine) has a chemical structure similar to ephedrine. Because of its similarity to ephedrine, Synephrine can cause similar side effects. Based on the potential for cardiovascular toxicity of Synephrine, Health Canada in January 2010 issued guidelines limiting the maximum dose of Synephrine, and prohibiting the sale of health products containing both Synephrine and caffeine without prior submission of clinical evidence of the product’s safety.
Thus, Solo Slim contains two different drugs that can cause heart attacks and strokes. Further, Solo Slim also contains caffeine, which in combination with Synephrine was regarded as potentially dangerous in itself by the Canadian health agency. This chemical makeup makes Solo Slim particularly dangerous for people with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
As we reported in an earlier post, consumers should return Solo Slim immediately to the place of purchase for a full refund, and contact their physician if they experience any side effects as a result of taking the product. |
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| September 09, 2010 |
| FDA Orders Label Changes for Gadolinium-Based Contrast Agents |
| Posted By DeCarli Law |
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The U.S. Food and Drug Administration (FDA) announced today that it will require significant label changes for gadolinium-based contrast agents (GBCAs) in order to reduce the risk of nephrogenic systemic fibrosis (NSF).
The most significant label change is the recommendation that Omniscan, Magnevist and Optimark NOT be used on people with chronic, severe kidney disease, such as dialysis patients, or those with acute kidney injury (AKI). This follows the determination by FDA staff last fall that Omniscan, Magnevist and Optimark are the gadolinium-based contrast agents most likely to cause NSF.
The new labeling also recommends that healthcare professionals:
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Screen patients prior to administration of a GBCA to identify those with AKI or chronic, severe, kidney disease. These patients appear to be at highest risk for NSF.
- Use the clinical history to screen patients for features of AKI or risk factors for chronically reduced kidney function.
- Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for the diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging modalities.
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Monitor for signs and symptoms of NSF after a GBCA is administered to a patient suspected or known to have impaired elimination of the drug.
- Not repeat administration of any GBCA during a single imaging session.
The complete text of the FDA's Safety Announcement may be found HERE.
Unfortunately, this label change comes too late for some people with kidney disease or AKI who were injected with Omniscan, Magnevist and Optimark and as a result, developed NSF. Symptoms of NSF include scaling, hardening and tightening of the skin; red or dark patches on the skin; and joint stiffness. NSF can also cause fibrosis of internal organs that may lead to death. There is no effective treatment for NSF.
If you or a loved one developed any of the NSF symptoms listed above after treatment with a gadolinium-based contrast agent, you may have a legal claim. However, these and all personal injury claims are subject to statutes of limitations -- laws that place deadlines on when a claim may be made. Call the NSF lawyers at DeCarli Law for a free, no-obligation telephone consultation to learn your legal options. We are experienced helping people stricken with NSF, and can provide you with additional information about NSF and your legal rights. |
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| Continue reading "FDA Orders Label Changes for Gadolinium-Based Contrast Agents" » |
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| September 09, 2010 |
| Zarah, a New Generic Form of Yasmin, to Be Sold in the U.S. |
| Posted By DeCarli Law |
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Bad news for women’s health: yet another generic form of the oral contraceptive Yasmin will be sold in the United States. Watson Pharmaceuticals, Inc. announced on Tuesday that it has received approval from the F.D.A. to sell Zarah, a generic version of
Yasmin.
Watson Pharmaceuticals obtained permission to market Zarah in the U.S. by using a procedure called an Abbreviated New Drug Application. This procedure is used to secure approval for generic drugs, and generally does not include any animal or human data to establish the drug’s safety and effectiveness.
Yasmin was previously available in generic form under the name Ocella. Yasmin, Ocella and now
Zarah contain
drospirenone and ethinyl estradiol.
Drospirenone is a synthetic progestin that acts as a potassium-sparing diuretic. This means that women using Yasmin, Ocella and
Zarah run the risk of developing abnormally high potassium levels in their bodies, which can lead to
gallbladder disease,
pulmonary embolism (PE),
deep vein thrombosis (DVT), stroke, heart attacks, and even death. Another similar birth control formulation that also comes with these risks is
YAZ, manufactured by Bayer Healthcare Pharmaceuticals.
Read HERE
to learn more about
Zarah and its risks.
Thousands of women have been injured by YAZ, Yasmin and Ocella side effects, and unfortunately, more women will now be at risk from
Zarah. If you or a loved one has suffered from any of the above side effects after using
Zarah, Yasmin, Ocella or YAZ, contact the Zarah lawyers and YAZ attorneys at DeCarli Law to learn your legal options. We provide free, no-obligation telephone consultations. You will be able to speak to an attorney, not a legal assistant or other support staff member. If we take your case, you will have no obligation to pay us fees unless we obtain a recover for you.
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