FDA: Vertex Black Box Warning Must Include Fatal Skin Rash Info

The U.S. FDA yesterday placed new restrictions on the hepatitis C drug Incivek, manufactured by Vertex Pharmaceuticals Inc. The FDA warning comes on the heels of new information that the drug has caused fatal skin rashes in some patients, and may signal the end for the companies HPV drug Incivek.

The FDA warning letter indicates that Vertex pharmaceuticals Inc. has misbranded the drug Incivek in violation of the FD&C act, 201 U.S.C 352(a) & 321 (n). As well as Cf. 21 CFR 202.1 (e)(5)(i), (iii);(e)(6)(i).

The FDA will now require Vertex pharmaceuticals to publish an expanded warning label, more commonly known as a “blackbox warning”, on the packaging for the drug Incivek. The warning must be placed in a prominent area of the packaging.

The FDA only last year had approved Incivek to be used as combination therapy, administered only along with the drugs Peginterferon alfa, and Ribravirin. Currently Incivek has product labeling information that contains warnings and precautions regarding the use of this drug involving pregnancy, serious skin reactions, rash, anemia, drug interactions, laboratory tests and hepatic impairment. The most common adverse reactions in patients receiving Incivek combination therapy were rash, anemia, nausea, hemorrhoids, diarrhea, anorectal discomfort, itching, dysgeusia, fatigue, vomiting and an anal itching sensation.

Vertex pharmaceuticals Inc. has overstated the efficacy of the drug in its promotional materials, and the FDA considers these overstatements misleading as they contain misrepresentations that the drug is better or more effective than previously demonstrated by substantial evidence or clinical experience.

FDA guidelines also indicate that promotional materials are misleading if the suggestion is made that the drug indicated is safer than previously demonstrated. The branded story in the promotional materials distributed by Vertex pharmaceuticals Inc. claims that rash is not a serious side effect, when this statement is in fact not true.

Vertex pharmaceuticals Incorporated distributes the Incivek medication guide within the packaging of the drug, and in it it cites rash with or without itching as a skin reaction that should prompt an urgent call to a health care provider immediately because, “Sometimes the skin rashes and other skin reactions can become severe and require treatment in a hospital.”

Japanese media has reported to patients in Japan had developed toxic epidermal necrolysis, a skin condition which can be fatal. One of the patients discontinued the combination treatment therapy and survived, while the other patient developed multiple organ failure and died.

The warning label on the packaging for Incivek had already indicated for patients to discontinue use of the drug if a severe rash occurs, the new warning must now indicate that severe rashes have resulted in death.

Hepatitis C is an infectious disease affecting the liver, and is caused by the hepatitis C virus(HCV). Normally the infection is asymptomatic, and chronic infection leads to liver scarring and eventually to cirrhosis of the liver over time. Patients with chronic cirrhosis of the liver generally develop liver cancer, liver failure or throat cancer.

HCV is normally spread from patient to patient through blood to blood contact generally associated with IV drug usage, blood transfusions and poorly sterilize medical equipment. It is estimated that up to 170 million people globally are infected with the hepatitis C virus.

Article by Jim Donahue

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