Glendale Personal Injury Lawyer - FDA & Prescription Drugs

Blue Bonnet Spread Recalled After Label Mixup

Greg Owen — Sat, 14 Nov 2009 14:09:00 GMT

ConAgra Foods, along with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a 1,120 cases of 15 oz. tubs of Blue Bonnet Spread. The lot was mispackaged as the lid used is for regular Blue Bonnet Spread and the tub portion describes the product as Blue Bonnet Light Spread. The product inside of the tub is regular Blue Bonnet Spread. As a result, the product tubs do not declare the allergen whey (milk), as an ingredient.

People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. No allergic reactions have been reported.

The product UPC on the tub is 27000-00930. The product lid will not have the blue ribbon graphic bearing the word "Light" that is found on the tub portion of the package. The rim of the lid will feature the batch code "2247923200" and a Sell By date of March 18, 2010.

ConAgra Foods became aware of the issue after receiving a report from a store where the tub did not match the lid or the case.

Consumers should return the product to the store where it was purchased for a full refund. Consumers with questions may call 866-518-4177 (9:00 a.m. to 7:00 p.m. CST daily) or visit www.bluebonnet.com for more information.

Originally posted at InjuryBoard by Greg Owen

FDA Advises Patients to Remove Skin Patches Before MRI

Greg Owen — Mon, 09 Mar 2009 08:00:00 GMT

The FDA released a statement advising patients undergoing an MRI (magnetic resonance imaging) scan to notify their doctor if they are wearing medicated skin patches. Some skin patches contain aluminum in the non-adhesive backing and as a result will conduct electricity causing burns at the patch site.

The FDA reports that fewer than half dozen patients have sustained such burns. All burns were reported by patients wearing nicotine patches, and none of the burns were serious.

Originally posted at InjuryBoard by Greg Owen

Allie's Voice Being Heard By Big Pharma

Greg Owen — Wed, 07 Jan 2009 13:07:00 GMT

Last year, over 80 Americans died and hundreds more became ill after receiving tainted doses of the blood thinner heparin. After an investigation, it was discovered that the contaminated batch of the drug was manufactured at Baxter International’s China location. The discover lead to a prompt recall followed by many questions about imported medication.

Among those questioning their safety was Allie Beaty, a diabetic woman with a mission to raise the standard of FDA oversight on imported medicine. After hearing of the recall, Allie posted a video on YouTube titled “Is my insulin tainted?” She also manages a website, Alliesvoice.com where a diabetes think group comes together to share videos and input. After multiple attempts to contact even the largest drug companies, only a handful were willing to answer Allie’s questions in regards to where their heparin is manufactured and under what standards.

After receiving so few responses, Allie is now more determined than ever to “make the world safer for people with diabetes.”

Originally posted at InjuryBoard by Greg Owen

Merck's Gardasil Not Cleared for Older Women

Greg Owen — Fri, 27 Jun 2008 21:20:35 GMT

At this time the cervical cancer vaccine known as Gardasil will not be approved for older women. That is the word to Merck & Co from the U.S. regulators.

Merck was seeking approval to extend the availability of the drug to women between the ages of 27 and 45. However, the U.S. Food and Drug Administration (FDA) has stated that there are ‘issues’ that are a road block to the requested approval.

Gardasil is used to protect against more strains of the Human Papillomavirus that causes cervical cancer and genital warts in females between the ages of 9-26. This lack of clearance is clearly a disappointment to Merck. Gardasil was one of the company’s more successful products.

Additional Information Pertaining to Defective and Dangerous Products

Originally posted at InjuryBoard by Greg Owen

FDA Warns Singulair Users and Physicians

Greg Owen — Fri, 28 Mar 2008 17:45:37 GMT

The Food and Drug Administration (FDA) informed healthcare professionals and patients alike of their findings regarding the possible links between the use of Singulair and changes in mood and behavior. Their concerns pertain to suicidal thinking, changed behavior and indeed suicide.

Merck, the manufacturer of Singulair, is stressing that this warning is based on a small number of studies. (Still cause for concern, I'd say). Singulair is a leukotriene receptor antagonist. It is used to prevent exercise-induced asthma and to treat asthma and the symptoms of allergic rhinitis.
Last year Merck's Singulair reached $4.3 billion in sales. Their Singulair labeling does not current mention risk of possible mood/behavior changes and/or suicidal thoughts.

Additional Information Pertaining to Dangerous and Defective Products

Originally posted at InjuryBoard by Greg Owen

Deaths and Injuries Linked to Heparin

Greg Owen — Wed, 19 Mar 2008 13:36:37 GMT

The Food and Drug Administration (FDA) is working to identify the contaminant that has been found in Heparin, which may be linked to as many as 19 deaths. Although, at this time, the FDA has not established a direct causal link. The drug Heparin is used in dialysis and heart procedures to stave off blood clots. Baxter sells somewhere in the range of 35 million units of heparin sodium injection multi and single dose vials per year in the U.S. alone. Those sales amount to approximately $30 million annually.

Initially, there were nine lot of heparin recalled by Baxter Healthcare corporation. The January 17, 2008, recall was initiated due to reports of a sudden increase in adverse effects from consumers of the product. A host of health problems were reported including, vomiting, abdominal pain and decreased blood pressure.

Baxter released a recall update on February 11, 2008. The company announced that the recall would be expanded due to the fact that they had received reports that consumers were experiencing adverse effects from additional heparin products. It was at that time that Baxter decided to suspend further production of heparin. Although, the vials of heparin that were on the market remained on the market due to a concern pertaining to a diminished supply of heparin to consumers. Baxter also noted, at that time, that adverse effects from the drug could actually be life-threatening.

Shortly after the February 11, 2008 expanded recall, it was reported by The Wall Street Journal that the active ingredient in heparin came from none other than China. At this time, the FDA is inspecting the Chinese facility, but have yet to make an announcement as to their findings. As recently as February 28, 2008, it was announced by Baxter that it would recall all sizes and lots of heparin. By the last week in February the only heparin product that was still on the market was the Haparin IV bags. On the heels of the expanded recall in late February, it was reported by the FDA during the first week of March that a molecule very similar to heparin had been found in the heparin ingredients sent to Baxter by Scientific Protein Laboratories (SPL).

The FDA has reported that up to 21 deaths and 448 allergic reactions may be linked to Heparin. The reports continue to come in and the exact numbers of people adversely effected by this drug are currently unknown, but the numbers continue to grow. Stay tuned for further updates.

Further Information Pertaining to Dangerous and Defective Products

Originally posted at InjuryBoard by Greg Owen

Actavis Recalls Remaining Patches as a Precaution

Greg Owen — Fri, 07 Mar 2008 16:53:45 GMT

Actavis Inc., announced that its subsidiary Actavis South Atlantic LLC is moving forward with the recall of all of the Fentanyl transdermal system CII patches that were sold in the U. S.

The concern pertains to a possible defect that could cause a leakage of the fentanyl gel. Initally, 14 lots of the patches were recalled. However, it is unknown if the defect is present in patches that are still available to the public. Accordingly, Actavis Inc. has expanded its original recall. The patches in question were manufactured by Corium International Inc. The recall does not include Fentanyl patches sold in Europe. Fentanyl is a potent opioid medication. Using the defect patch could cause respiratory depression and possible overdose, which could be fatal. If you have purchased this product, please go to the link provided for additional information.

Additional Information Pertaining to Dangerous and Defective Products

Originally posted at InjuryBoard by Greg Owen

FDA Issues a Recall on Class of Bone Drugs

Greg Owen — Fri, 11 Jan 2008 17:24:51 GMT

Although a defective drug recall has not been issued at this time, the FDA has issued an alert regarding a class of bone-density drugs known as bisphosphonates. It appears the drugs can cause severe bone, joint and/or muscle pain.

Severe pain may occur soon after taking the drug, or it may take years to occur. It is currently unknown exactly what the risk of severe musculoskeletal pain is for an individual taking this class of drugs. Please see the full article to see exactly which bone drugs are named.

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Originally posted at InjuryBoard by Greg Owen

Making a Difference - A Medical Malpractice Story

Greg Owen — Fri, 04 Jan 2008 17:54:03 GMT

As a result of the death of their beloved son Michael, due to what is believed to have been medical malpractice, David and Patty Skolnik helped push through House Bill 1331 better known as The Michael Skolnik Medical Transparency Act.

"The Michael Skolnik Medical Transparency Act will make public, via a Web site, information about doctors' license status and medical malpractice settlements." Initially, all doctors will not have to provide updated information. However, when licensed doctors wish to renew their license they must provide information regarding their malpractice convictions, if any.

The bill came about when the Skolniks' only son, Michael, 22, received what the Skolniks describe as unnecessary surgery from an inexperienced doctor who jostled Michael's brain. After the surgery, Michael was half-blind, partly paralyzed, was psychotic and had the reasoning ability of a third-grader. On June 4, 2004 Michael died, after what the Skolniks describe as two years of hell and $4.8 million in medical expenses. Subsequent to the surgery, David and Patty found out that the doctor who preformed the surgery on their son, not only had a malpractice claim and settlement in Georgia, he had only done the procedure once before. Now, when someone is in the position of needing to choose a surgeon they can make an educated decision instead of a stab in the dark. Each doctor's records will be open for all to see. The disclosure will cover the doctors' records in all states. Patty Skolnik said "I'm really pleased that it became law, and I'm pleased it went through with Michael's name on it."

For more information on this subject, please refer to the section on Medical Malpractice and Negligent Care.

Originally posted at InjuryBoard by Greg Owen

Merck Recalls Childrens' Vaccines

Greg Owen — Fri, 21 Dec 2007 16:55:31 GMT

Merck & Co Inc have recalled approximately 1.2 million doses of its popular childrens' vaccines. It is feared that the production equipment was not adequately sterilized. According to the U.S. Centers for Disease Control and Prevention, the recalled vaccine is used to protect against the leading cause of meningitis in children under 5 years old.

The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low," a spokesperson for Merck said. Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, advised parents to look for signs of infection at the site of inoculation the first week following the administration of the shot.

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Originally posted at InjuryBoard by Greg Owen