Galveston Bay Personal Injury Lawyer - Diabetes

FDA Reinforces Pancreatitis Warnings Associated with Byetta

Scott Kappes — Thu, 21 Aug 2008 16:02:33 GMT

In October of 2007 the FDA first warned healthcare professionals about a possible link between the type 2 diabetes medication Byetta and acute pancreatitis. This warning urged physicians to be on the lookout for warning signs and symptoms of acute pancreatitis in patients taking Byetta. In January of 2008 the label of Byetta was amended to include acute pancreatitis in the precautions section of the drug’s label. Since last October the FDA has seen six cases of hemorrhagic or necrotizing pancreatitus in patients taking Byetta. Of these six cases all have needed hospitalization have two have died. The other four were still in the process of recovery when the FDA published the update.

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

Patients taking Byetta should seek immediate medical attention if they experience persistent, unexplained abdominal pain. While this is no cause for patients who are effectively controlling diabetes with Byetta to abandon the medication it should encourage them to be very cognoscente of the warning signs associated with pancreatitis and allow them to act more quickly if a problem were to occur.

Originally posted at InjuryBoard by Scott Kappes

Stricter Rules for Diabetes Medications

Scott Kappes — Mon, 07 Jul 2008 13:05:23 GMT

A panel of outside medical experts met last week to discuss the need for new diabetes medications to undergo more extensive testing to prove that they do not increase the likelihood of cardiovascular problems. The panel voted overwhelmingly, 14-2, to require the new regulations for diabetes medications. Over the past year the diabetes medications Avandia and Actos have been at the center of the controversy after studies linked the drugs to an increased risk of heart attack and stroke among other heart conditions.

The panel recommended the FDA instruct drug manufacturers to conduct long-term studies in order to rule out cardiovascular risks in the diabetes drugs. Most panel members also suggested that companies start the studies before the drug is approved and complete them after approval.

The FDA is not required to follow the advice of advisory panels but usually does.

Recent studies have shown that the diabetes epidemic is not going away anytime soon. Over the past two years we have seen a 17 percent increase in the number of people with diabetes, bringing the number up to 24 million in the US alone. With more people taking diabetes medications than ever before, the safety of these medications should be of the utmost concern to the FDA.

Originally posted at InjuryBoard by Scott Kappes

Regranex Diabetic Foot Gel Gets Boxed Warning

Scott Kappes — Fri, 06 Jun 2008 15:42:41 GMT

Today the FDA informed healthcare professionals that a boxed warning has been added to the label of Regranex gel because of an increased risk of cancer and death observed in patients that have been treated with three or more tubes of the gel. Regranex is used to help heal leg and foot wounds commonly experienced by many diabetics. In March the FDA issued an early communication to warn patients that study data suggested these increased risks might exist.

The findings come from a long-term study comparing 1,600 patients who took Regranex with 2,800 patients who did not, according to the FDA.

Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said Johnson & Johnson closely monitored patients for reports of cancer, which spreads through uncontrolled cell division.

Over 750,000 people have used Regranex since it received FDA approval in 1997. It is shame that we are only finding out about these serious risks now.

Originally posted at InjuryBoard by Scott Kappes