Archive for the 'Medication' Category

Study Shows Paxil Causes Increased Birth Defects

Wednesday, June 11th, 2008

New studies show that Paxil causes increased birth defects when taken during the first trimester of pregnancy.  In many cases the most prominent birth defects were atrial and ventricular septal heart defects (holes in the heart chamber walls).  Other possible birth defects may include:

 

Difficulties with breathing

Seizures

Vomiting

Low blood sugar

Tremor

Irritability

 

If you or a loved one has been harmed by a dangerous drug or product, contact the attorneys at Cappolino Dodd Krebs LLP today, at 1-800-460-0606.

Albuterol Inhaler Users To Begin Using New Type of Inhaler

Saturday, June 7th, 2008

No CFC (chlorofluorocarbon) propelled albuterol inhalers will be manufactured or sold inside the United States after December 31st, 2008. This change is a part of the Clean Air Act and the International Environmental treaty. Because CFCs are harmful to the environment, the Food and Drug Administration recommends that users switch to HFA (hydrofluoroalkane) propelled inhalers soon. Manufacturers have been increasing production of HFA inhalers, so a safe and effective alternative to CFC inhalers are available now.

Patients currently using CFC albuterol inhalers should talk to their doctors about making the transition to a different inhaler. HFA-propelled inhalers have a softer spray, and require a different priming, cleaning and drying routine.

 

If you or a loved one has been harmed by a dangerous drug or product, contact the attorneys at Cappolino Dodd Krebs LLP today, at 1-800-460-0606.

Merck Wins a Vioxx Case

Saturday, June 7th, 2008

On June 4, 2008, the New Jersey Supreme Court decided that Merck is not responsible for monitoring the health of Vioxx users who have not shown any sign of injury. The court voted 5-1, dismissing a class action lawsuit filed by users of Vioxx who were seeking to have Merck pay for continuous medical monitoring to discover Vioxx related injuries.

In 2004, the U.S. Food and Drug Administration (FDA) ordered Vioxx to be removed from the market due to a link between Vioxx and heart attacks and other cardiac related fatalities. During the time period of the drugs inception in 1999 to 2003, Vioxx is responsible for more than 27,000 heart related incidents.

In this recent decision, the judges ruled that since the Vioxx users involved in the lawsuit did not have established injuries, they could not establish that the drug caused them harm.

There are defective drug attorneys working to help those who have suffered serious injuries as a result of defective prescription medication.

Asthma Patients Will No Longer Have Albuterol Inhalers

Tuesday, June 3rd, 2008

The Food and Drug Administration (FDA) has stated that at the end of the year albuterol inhalers, which are commonly used to treat asthma, will no longer be available for use.

Albuterol inhalers typically use a chemical called chlorofluorocarbons, or CFCs. This chemical is used to propel the drug into the patient’s lungs, but has been found to be damaging to Earth’s ozone layer.

The Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer have settled on a treaty in which the United States has agreed to stop producing and importing substances harmful to the ozone, including CFCs. Therefore, as of December 31st, inhalers containing these chemicals can no longer be made or sold in the U.S.

The alternative will be inhalers using hydrofluoroalkanes, or HFAs. The FDA has already approved ProAir HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol, as well as Xopenex HFA Inhalation Aerosol which contains levalbuterol.

The FDA has confirmed that these alternatives are safe and effective for those switching from CFC inhalers, although they will taste and feel different. Each has different priming, cleaning, and drying instructions to prevent the medicine from building up in the inhaler.

The FDA states that there is an adequate supply of the HFA inhalers as increased production has already started, but urges those with asthma to start talking to their doctors now.

Defective drug attorneys are working on cases in which prescription drugs have caused harmful and serious side effects.

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.

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.