Trusted Pharmacy Blog|New Drugs, Drug News, Health, Medications, Diseases

An effective treatment for acne has been linked with potentially harmful changes in the blood and damage to the liver. Almost 90% of patients who used isotretinoin tablets (Accutane, Roche) were found to be at an increased risk for high triglyceride and cholesterol levels. Liver function tests showed the presence of enzymes that normally signal liver damage.

The prescribing information mentions that 25% of patients may sustain higher levels of triglycerides while taking the drug and that higher liver enzyme levels will affect 15°%.

Researchers at the University of California in San Francisco monitored almost 14,000 patients between 13 and 50 years of age between 1995 and 2002. Forty-four percent of patients who had normal tri-glyceride levels before therapy developed high levels after taking the drug. High cholesterol levels developed in 31% of patients, and elevated liver enzymes developed in 11%. When patients stopped taking the drug, liver enzymes and cholesterol generally returned to normal levels.

In Britain, isotretinoin (Roaccutane) is more commonly given as a cream. The study does not indicate whether that form has the same effects.

Accutane medication was first approved in 1982. In 2005, the FDA announced stricter regulations in an effort to reduce an increased risk of miscarriage and birth defects associated with the drug.

The FDA is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane generic, Roche) online. Isotretinoin is approved for the treatment of severe acne that does not respond to antibiotics. If improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The Web page  will be positioned as a search result on Google and other search engines when consumers initiate an online search for the drug under any one of its four names. Isotretinoin is also sold as generic versions called Amnesteem, Claravis, and Sotret.

The Web page warns that the drug should only be taken under the supervision of a physician or a pharmacist.

The FDA and the manufacturers of isotretinoin tablet have developed special safeguards to reduce the risks of isotretinoin, including a strict distribution program, called iPLEDGE, to ensure that women using isotretinoin do not become pregnant and that pregnant women do not use isotretinoin.

Isotretinoin is available only at pharmacies registered for this program. The distribution program is designed to prevent the sale of isotretinoin over the Internet.

In October, the FDA stated that it had received 30 reports of acute pancreatitis in patients taking exenatide (Byetta, Amlyn Pharmaceuticals) for the treatment of type-2 diabetes. Of 30 patients, 27 had at least one other risk factor for acute pancreatitis such as gallstones, severe hypertriglyceridemia, or alcohol use.

In six patients, the pancreatitis symptoms began or worsened soon after the dose of exenatide was increased from 5 mcg twice daily to 10 mcg twice daily. Twenty-one patients were hospitalized.

Read the rest of this entry »

Roche has discontinued the manufacture and distribution of isotretinoin (Accutane drags, Roche), a medication for severe acne, in the U.S. The company said that the withdrawal was based on business reasons. Isotretinoin will continue to be available as a generic agent.

First developed as a chemotherapy agent, the capsules were approved in 1982 and became Roche’s second-largest selling drug before its patent expired in 2002 and other companies began marketing generic versions.

Sources: Bloomberg News, June 26, 2009

Adding unfractionated heparin (UFH) to standard therapy with enoxaparin (Lovenox, Sanofi-Aventis) may lead to excessive anticoagulation and should be avoided, according to the STACKENOX (Stack-on to Enoxaparin) study. An additional intravenous (IV) bolus of UFH resulted in complete inhibition of thrombin generation, even when it was given up to 10 hours after the last enoxaparin dose. Moreover, tests commonly used to monitor UFH anticoagulation, such as activated clotting time (ACT), do not detect the potential overanticoagulation that results from the stack-on therapy.

Read the rest of this entry »

Protalix BioTherapeutics, Inc., has announced the approval of a protocol for prGCD, a proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of patients with Gaucher disease. This rare and serious lysosomal storage disorder is characterized by debilitating symptoms.

Read the rest of this entry »