Topeka Personal Injury Lawyer - Defective Drugs

Remaining Heparin Sodium Vial Products Recalled by Baxter

Jenny Albano — Sun, 02 Mar 2008 15:26:51 GMT

Baxter International Inc., in conjunction with the FDA, is recalling all remaining lots and doses of heparin sodium vial products, including all multi-dose, single-dose vials and HEP-LOCK heparin flush products. The company recently recalled nine lots of the heparin sodium injection multi-dose vials as a precaution due to more than normal reports of adverse reactions from the product. Production was suspended earlier in February.

Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.

Even though most consumers who experienced adverse side effects took the multi-dose products, Baxter wants to make sure that consumers are safe and is now recalling all remaining heparin sodium injection and heparin flush products that are still being sold.

In addition to the 100 units/mL, 10 mL, and 30 mL multi-dose vials that were already recalled, the company is adding the following:
the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.

This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

Almost all adverse side effects reported by consumers have involved three specific areas of the product's use - renal dialysis, invasive cardiovascular procedures and apheresis procedures. To see a list of adverse side effects click here. Consumers have been advised to stop using these recalled products and segregate the product for the rest of its inventory.

Originally posted at InjuryBoard by Jenny Albano

F.D.A. Hands Down Warning on Antidepressants and Headache Drugs

Matthew Bergmann — Sun, 23 Jul 2006 10:03:33 GMT

A new warning could be placed on prescriptions for Prozac and similar antidepressants if drug manufactures follow the recent request of the Food and Drug Administration. The F.D.A. has asked that additional information be added about a rare but potentially fatal lung disorder that can affect babies born to mothers who take the drugs during pregnancy.

A warning was also made about the risk of mixing antidepressant medications with common migraine drugs called triptans. The agency believes that sucha cocktail can lead to a life-threatening condition called serotonin syndrome.

Infants with the lung problem, called persistent pulmonary hypertension, have high pressure in the blood vessels of their lungs and are not able to get enough oxygen into their bloodstreams. Only a few babies per 1,000 develop the disorder shortly after birth, but a recent article in The New England Journal of Medicine found that babies whose mothers took antidepressants in the second half of pregnancy had six times the expected risk of it. This study was release just after the Journal of the American Medical Association put out a report noting the possible risk of depression relapse in women who stopped taking prescribed antidepressants during pregnancy.

The F.D.A. emphasized that women who are expecting and currently taking antidepressants should not discontinue use without first talking with a doctor.

To read more on this visit http://www.nytimes.com/2006/07/20/health/20prozac.html

Originally posted at InjuryBoard by Matthew Bergmann

Ketek Antibiotic Linked to Liver Failure and Death

Matthew Bergmann — Thu, 20 Jul 2006 09:30:06 GMT

The heavily debated antibitoic Ketek has been recently linked to liver failure and possibly death.

That was the warning given last month as the Food and Drug Administration issued a statement that the drug could, in rare circumstances, cause serious liver damage. Dr. John Jenkins, director of the Food and Drug Administration's Office of New Drugs stated that there is a serious risk of liver injury with Ketek, but that the agency did not yet know whether the risks posed by Ketek were greater than those of other antibiotics.

Approved to treat bronchitis, sinusitis and mild-to-moderate pneumonia, Ketek is manufactured by Sanofi-Aventis, the French drug giant. Sanofi-Aventis responded with a written statement in which the company believe the benefits of Ketek owtweigh the risks when the drug is used as directed for its approved indications.

It appears that the F.D.A. warning came after a long debate within the drug agency as to how to address Ketek's risks. Besides liver problems, other complications from Ketek can include cause blurred vision and loss of consciousness, and in patients with myasthenia gravis, a rare neurological disorder, use of the drug can cause death. Thus far, 23 people have suffered serious liver injuries, with 14 patients in the United States suffering liver failure and at least four deaths have been confirmed.

Another major concern is the use of Ketek in children with ear infections. However, Sanofi-Aventis has since "paused" it's pediatric clinical trials.

New warning labels on Ketek presriptions advise those who show signs of janudice or other liver injury to stop taking the drug.

Originally posted at InjuryBoard by Matthew Bergmann

Celebrex Can Double Heart Attack Risk

James B. Biggs — Sun, 07 May 2006 09:41:27 GMT

A recent study from the New Zeland Medical Research Institute and published in the Journal of the Royal Society of Medicine has shown that people taking Celebrex double their risk for a heart attack when compared with users of similar drugs.

The study looked at six seperate studies involving 12,780 patients in an effort to determine if the increased risk of cardiovascular problems with Vioxx was also present with Celebrex.

It found a 1.88-fold increased risk of heart attack when Celebrex compared with the other arthritis treatments.

Previously, similar concerns has arisen over Merck's blockbuster drug Vioxx, as it was withdrawn in September 2004 after a study showed it doubled patients risk of heart attack and strokes after 18 months of use. These particular findings may be critical, as futher reserach could establish that Celebrex's risk to users may be similar to that of Vioxx.

Pfizer, the manufacturer of Celebrex, is on track to post sales of more than $2 billion in 2006, up from $1.7 billion in 2005.

Originally posted at InjuryBoard by James B. Biggs

Vioxx Recalled

Matthew Bergmann — Tue, 07 Mar 2006 09:00:00 GMT

Vioxx, a non-steroidal anti-inflammatory (NSAID) medication, was prescribed for just five years before its manufacturer, Merck & Co., issued a worldwide voluntary recall. One of the most widely used drugs, Vioxx was prescribed to children and adults to manage symptoms of rheumatoid arthritis, women to ease their menstrual cramps, and a variety of other people to alleviate swelling and acute pain.

Vioxx fell under the NSAID subclass of Cox-2 inhibitors, was thus touted as gentler on the stomach than other NSAID medications. Unfortunately, initial studies also suggested Vioxx use significantly increased a patient's chance for sudden cardiac arrest. Closer scrutiny of the drug ensued, and the FDA (Food and Drug Administration) determined the drug's benefits outweighed its risks. The FDA did mandate additional warnings on the drug's labeling. However, no recall was issued, and another study was begun to assess the ability of Vioxx to prevent recurring colon polyps. Vioxx did show promise in the prevention of these pre-cancerous growths, but more frightening evidence caused Merck to suddenly halt the study and yank the drug from pharmacies worldwide. Compared to patients receiving a placebo, long-term Vioxx users had exactly double the chance of suffering a cardiovascular event, such as heart attack, stroke, or blood clot. Patients worldwide are concerned, and stunned that in the wake of the early evidence of its danger, Vioxx was promoted for several more years. Please contact our law firm to have one of our attorneys review your case.

Originally posted at InjuryBoard by Matthew Bergmann

Ortho EvraÂ® Patch -- FDA Warnings & Potential Dangers

Matthew Bergmann — Fri, 03 Mar 2006 09:00:00 GMT

A new FDA warning alerts consumers about potential dangers of the Ortho EvraÂ® patch. First approved by the FDA in November 2001, the Ortho EvraÂ® birth control patch is a transdermal patch that is applied to the skin and worn for one week.

The patch is replaced every week for 3 weeks, followed by one patch-free week. Currently, Ortho EvraÂ® is the only birth control patch available and its unique method of administration sets it apart from other contraceptive options on the market. The makers of the patch, Ortho-McNeil Pharmaceutical, Inc., have advertised it as a safe and convenient alternative to the popular birth control pill.

Since its approval, the patch has been prescribed to nearly 5 million women. Initially, the manufacturer informed consumers that the risk of serious complications from patch use was similar to the risks associated with oral birth control use. More recent research, however, shows that women who use the patch are actually exposed to 60 percent more estrogen the pill users, and in November 2005, a warning was added to the Ortho EvraÂ® label to alert consumers about the dangers of increased estrogen exposure, which can include heart attacks, strokes, and blood clots. These serious health risks can result in coma or death.

Unfortunately, for some Ortho EvraÂ® birth control patch users, the new warning is far too late. Well over 10,000 reports of adverse reactions and nearly 50 serious injuries and deaths have been linked to the product. As the startling risks of the patch become more evident, the number of life-threatening injuries and deaths that have been linked to its use continues to grow. Davis, Unrein, McCallister, Biggs and Head, L.L.P., can provide assistance to victims who have suffered serious injury as a result of the Ortho EvraÂ® patch and to the families of victims who died as a result of patch use. We have the knowledge and record of success you are looking for. Please contact our attorneys today to discuss your case.

Originally posted at InjuryBoard by Matthew Bergmann