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May 2012 Archives

New bill could improve FDA inspections of foreign drug companies

Under current agreements, pharmaceutical companies and medical device makers must pay user fees to help fund reviews of new drugs and other products that are conducted by the U.S. Food and Drug Administration. The FDA started collecting user fees from drugmakers in 1992 in order to help speed up the review process of new drugs in the U.S. However, this agreement must be renewed every five years, meaning that the current agreement will expire in September of this year.

What happens when you report a defective medical device? Nothing.

In previous posts on our Fairfield, Connecticut, pharmaceutical products liability law blog, we mentioned several medical devices that have been recalled due to the potential injuries patients could suffer from using the dangerous or defective medical devices. Some of these recalled products have included metal-on-metal hip implants and defibrillator leads.

Study: Antibiotic could be deadly for patients with heart disease

If you have ever suffered from a sinus infection, a severe cold or a viral infection, your doctor probably gave you a prescription for an antibiotic to help relieve your symptoms. One of the most common types of antibiotics that doctors prescribe for patients in Connecticut and throughout the entire U.S. is azithromycin, or the "Z-Pak."

No link between MS patients' deaths and Gilenya pill, FDA says

After clinical studies and postmarket studies reported that several participants had died shortly after taking Gilenya, which is a drug used to help treat those who suffer from multiple sclerosis, the U.S. Food and Drug Administration launched an investigation in order to determine whether the MS pill caused the patients to suffer fatal injuries.

Approval of take home HIV test under consideration in U.S.

It is estimated that as many as 240,000 people who are living in the U.S. are not aware that they are carriers of HIV. However, if the U.S. Food and Drug Administration does decide to approve a new take home HIV test called OraQuick, health advocates believe that more people in Connecticut and throughout the entire country would test themselves for the virus because they could take the tests in the privacy of their own homes without an appointment at a doctor's office or other facility.

Fentanyl patch can cause harm to children from accidental exposure

Patients in Fairfield, Connecticut, certainly deserve to be made aware of any side effects they could experience after starting a new medication. Prescription drugs often pose health risks, but consumers deserve to know what these risks are so that they can make informed decisions when it comes to taking medications to treat their health conditions.

Connecticut will receive $6 million from Depakote settlement

As we have mentioned before on our Fairfield pharmaceutical products law blog, drug companies do not always put consumer safety before profit. Although a prescription drug may be approved by the U.S. Food and Drug Administration to treat a certain medical condition, a pharmaceutical company might attempt to market the drug for other purposes that have not yet been approved by the FDA in order to increase sales and earn more money from Medicaid reimbursements.

Contaminated Tylenol led to infant's wrongful death, couple says

Any new parent in Fairfield, Connecticut, might tell you that one of the hardest things to watch is a newborn or infant getting his or her vaccinations during the child's first few checkups with a pediatrician. Some moms or dads might even admit to shedding a few tears of their own as they watched their babies cry and scream in pain. Fortunately, the little ones probably got over the pain rather quickly once they were back in their parents' arms, and a doctor might have even told parents to give their children a small dose of Tylenol to ease their discomfort from the vaccinations.

Doctors: Patients need to know about ACE inhibitor side effects

When physicians prescribe new medications to their patients in Connecticut, they are required to inform their patients about any side effects they may experience after taking a new drug, especially if a side effect could lead to the serious injury or death of a patient. Additionally, the U.S. Food and Drug Administration may require drug companies to put specific warnings on the labels of prescription drugs so that patients are fully aware of any risks associated with taking their medications.

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