Archive for August, 2008

Drug manufacturers may be liable for generics

Tuesday, August 26th, 2008

In a class action defective drug lawsuit against Pfizer Inc, plaintiffs in Pennsylvania are challenging how drug manufacturers can promote their generic products.

The lawsuit claims that purchasers of the epilepsy drug Neruontin and its generic equivalent, gabapentin, were given as prescriptions for an off-label use. The case states that the drug manufacturer illegally promoted the drug by manipulating medical literature and by using other tactics, and should be liable to consumers who were prescribed generic versions of the drug.

Generic drugs must contain the same active ingredients as the original brand-name drug. The US Food and Drug Administration (FDA) states that generic drugs are identical, or the bioequivalent, to the brand name drugs. This means that generics are identical in dose, strength, safety, route of administration, and intended use. Generics are usually available once the patent protections of the original drug have expired.

Good drugs used like this are no better than defective drugs. If you or a loved one has been harmed, it is important that you consult with an expert defective drug attorney for professional insight.

Byetta causing problems for some diabetes patients

Wednesday, August 20th, 2008

The US Food and Drug Administration reported this week it has been notified that patients are developing a potentially deadly form of pancreatitis while taking the popular diabetes drug Byetta.

The FDA received six new reports. Two of the patients died and four are recovering.

Federal regulators are working with Amylin Pharmaceuticals and Eli Lilly & Co. to develop a stronger warning label for the widely used drug. Regulators stress that patients who exhibit symptoms of pancreatitis should stop taking Byetta right away. Those symptoms include nausea, vomiting and abdominal pain. Regulators warn that it can be very difficult to tell the difference between acute and less dangerous forms of pancreatitis.

This isn’t the first time the FDA has addressed this problem. In October 2007, the FDA issued an alert that about 30 patients developed problems while taking the drug, though none of those patients died.

Earlier this week, a Virginia man filed a defective drug lawsuit in a California court alleging Byetta’s manufacturers failed to adequately test and monitor the side effects, and didn’t warn doctors or patients of the risk of developing pancreatitis.

Another Fentanyl Pain Patch Recall

Wednesday, August 20th, 2008

Watson Pharmaceutical is recalling more of their fentanyl pain patches because of their tendency to leak harmful fentanyl gel.

The manufacturer is recalling the 75mcg/hr fentanyl transdermal system patches sold in the US from wholesalers and pharmacies. These defective drug patches are used to manage persistent chronic pain that requires constant treatment with opioids.

The recalled patches in particular are from lot number 92461850 and have an expiration date of August 31, 2009. These patches were shipped to customers between January 30, 2008 and March 19, 2008.

According to Watson, some of the patches in this lot have been leaking fentanyl gel and exposing it to patients or caregivers. Fentanyl gel is a highly addictive opiate that is 80 times more potent than morphine. Direct exposure can cause serious effects such as trouble breathing, extreme tiredness, confusion, or death.