Archive for May, 2008

FDA Recalls Dietary Supplement

Friday, May 30th, 2008

On May 29, 2008, the U.S. Food and Drug Administration requested that Florida pharmaceutical company, SEI Pharmaceuticals, recall all lots of Xiadafil VIP tablets. The request made by the FDA follows previous actions taken by the state of Florida to prevent distribution of the drug. The FDA is advising consumers not to buy or ingest the product as the FDA may take further actions.

The drugs are being marketed illegally and are being recalled because they have been found to contain an undeclared ingredient that can cause alterations to blood pressure and other dangerous adverse side effects.

Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and claim they are able to treat erectile dysfunction, or ED. The tabs contain the same ingredient that is used in Viagra. The ingredient is known to cause serious, life-threatening side effects.

Xiadafil VIP Tabs are sold in 8 tablet bottles, labeled Lot # 6K029, or blister cards of 2 tablets, labeled Lot # 6K029-SEI. These lots have an expiration date of September 2009.

Defective drug attorneys are working on cases in which adverse side effects have been caused by dangerous drugs.

FDA and Medicare Work Together to Improve Medical Products

Tuesday, May 27th, 2008

On May 22, it was announced that the U.S. Food and Drug Administration (FDA) will be working in conjunction with the Centers for Medicare & Medicaid Services (CMS).

Both organizations working together will attempt to increase the capacity of the FDA to monitor the effectiveness of medical products. The proposed system is being called the Sentinel Initiative. It will create a new electronic system that will allow the FDA to query information through CMS that will allow them to monitor possible adverse effects of medical products.

The electronic system will maintain strict privacy. The information gathered will only be used to monitor the effectiveness of prescription drugs and medical devices. The intent is to be able to quickly determine if a product is dangerous.

Defective drug attorneys are working on cases in which serious effects of prescription drugs have caused life-long disability or fatality.

Prescription Acne Drug Solodyn Recalled

Friday, May 23rd, 2008

Medicis Pharmaceutical Corporation has voluntarily recalled an antibiotic that is used to treat acne, Solodyn.

All prescriptions filled after April 15th are subject to the recall. This includes lot numbers B080037 and B080038.

The recall is linked to a report that a pharmacist found the prescription drug Azasan in a bottle labeled Solodyn. Azasan is an immuno-suppressant that is used to treat rheumatoid arthritis and to prevent rejection in kidney transplant patients.

Azasan is associated with severe side effects, such as:

• Joint and muscle pain
• Diarrhea
• Chills
• Nausea
• Vomiting
• Infection
• Bleeding
• Decrease in red and white blood cells and platelets

Azasan is a yellow, triangular shaped pill with “75mg” imprinted on the side. Solodyn is a yellow capsule that has “DYN-090” imprinted.

Prescription drug defect attorneys are working on defective drug cases in which serious side effects have resulted from dangerous prescription drugs.

Launching of Google Health – Will Privacy Be Maintained?

Thursday, May 22nd, 2008

This week, web-giant Google launched its new Google Health feature. Google Health is an internet-based program for holding personal medical records. Right now, it offers four options—create Google Health profile, import medical records, explore online health services, and find a doctor. Those who support this new tool (such as several pharmacies and clinics) say that Google Health can help doctors avoid prescribing drugs that interfere with other medicines a patient may have taken and forgotten to mention. It can also link patients with similar medical problems together in support groups. Opponents maintain that the risk of hacking (and the subsequent release of confidential files) outweighs the benefits. For now, the professional advice for using Google Health appears to be “user beware.”

Drug Company in Columbia Agrees to Stop Manufacturing

Tuesday, May 20th, 2008

A drug company in Columbia has agreed to stop manufacturing prescription cough and prescription cold products due to repeatedly failing to have federal approval or pass inspections.

The Chief Executive Officer of Scientific Laboratories Inc., Amit Roy, along with President Rajeshwari Patel, signed a consent decree. The signing process took place earlier this month in a U.S. District Court in Baltimore.

The U.S. Food and Drug Administration (FDA) has sought to sanction the company because they have never received approval for their products. Scientific Laboratories Inc. has been making prescription drug products for other pharmaceutical companies. After the drugs were made, other companies could sell them under their own labels.

Under the consent decree that was signed, Scientific Laboratories is required to recall all products that it has sold since January 1, 2007. The company will require FDA approval before they will be allowed to manufacture any form of medication – prescription or over-the-counter.

Defective drug attorneys are working on cases in which people have suffered from serious illness as a result of negligence.

Drug Ad Legislation is Being Discussed by the Food and Drug Administration

Saturday, May 17th, 2008

Today, the U.S. Food and Drug Administration (FDA) is discussing legislation that could possibly change the way that pharmaceutical companies will be allowed to advertise prescription drugs.

According to the legislation, the FDA would require that all pharmaceutical companies include a toll-free number in their advertisements that would allow patients to report adverse side effects to the medication.

Certain lawmakers believe that the heavy amount of advertising being done by pharmaceutical companies is encouraging the over-prescribing of medication by doctors.

Last fall, the FDA passed legislation that requires all print advertisements to have a toll-free number included.

Defective drug attorneys are working on cases in which serious adverse side effects have resulted due to negligence on the part of medical staff or pharmaceutical companies.

Medical Device Recalled Due to Heparin Concerns

Tuesday, May 13th, 2008

On May 12th, Atrium Medical Corporation recalled specific lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. The Heparin-Coated Catheters are being recalled because of concerns about contaminated Heparin.

The Heparin-Coated catheters are used during heart bypass surgery for autotransfusion.

Heparin was recalled in January because of contamination. Since 2007, Heparin has been linked to about 100 fatalities. Many of those fatalities, in addition to hundreds of adverse reactions, have been linked to contaminated Heparin. Baxter International recalled almost all lots of Heparin in order to prevent further illnesses and death.

The contamination was traced to a manufacturing facility in China. The adverse reactions were caused by over-sulfated chondroitin sulfate that could not be detected during testing because of its similarities to Heparin.

Atrium is voluntarily recalling its Heparin-Coated catheters because it was discovered that they were manufactured with contaminated Heparin.

The manufacturers of prescription drugs can be found liable if the products are found to be defective because of negligence. Defective drug attorneys are working on cases in which serious illness or fatality has resulted from faulty prescription medications.

Voluntary Digitek Recall

Monday, May 12th, 2008

Actavis Totowa LLC has issued a voluntary recall of their heart drug, Digitek, as reported by the Orlando Sentinel. Digitek is a drug used to treat heart failure and abnormal heartbeats. The drug’s makers believe that some of the pills may have been released with twice the thickness, therefore twice the dose, of medicine recommended. The Sentinel says, “The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure.” Taking twice the recommended dosage can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia or death.


Digitek Becomes Scarce Following Recall

Friday, May 9th, 2008

The generic drug maker, Actavis Totowa LLC, recently recalled all lots of the prescription drug Digitek. It was discovered that some of the Digitek pills contained twice the approved dose of the main ingredient, which could cause serious adverse reactions and overdose.

The symptoms of a Digitek overdose include:

• Dizziness
• Vomiting
• Low-blood pressure
• Fatality

Digitek is a heart medication that is used to treat congestive heart failure and abnormal heart rhythms. Actavis is a major manufacturer of the drug. Although other companies do have small quantities, the recall has affected supplies of the drug.

Pharmacists have been advised to ration the available supplies of Digitek in order to provide the necessary prescriptions. Adverse reactions to Digitek should be reported to the Food and Drug Administration.

Defective drug attorneys are working on cases that involve the serious injuries that result from faulty prescription medication.

Terbutaline Linked with Autism

Wednesday, May 7th, 2008

Terbutaline is a prescription medication approved by the Food and Drug Administration (FDA) for treating asthma related symptoms. It works by relaxing muscles, which can stop an asthma attack.

Despite the fact that the drug is only approved for treating asthma, many obstetricians have used Terbutaline to try to prevent premature labor or to control contractions during birth. The “off-label” use of the drug has lead to serious disabilities. The serious risks involved in the use of Terbutaline by expectant mothers have been known since 1997.

Researchers have shown that Terbutaline can affect the placenta of a pregnant woman and cause serious birth defects, namely autism. The risks of Terbutaline become even greater in the case of twins.

The risks of Terbutaline during pregnancy are well known. If an obstetrician prescribes Terbutaline to a pregnant woman, they may be liable for the birth defects. Terbutaline attorneys are working on cases in which serious birth defects have resulted from medical negligence.