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Off-Label Medicine Use

Delaware Medical Malpractice Lawyers: Off-Label Medicine Use

A 60-year old woman claims improper medical treatment caused her to lose vision in one of her eyes. The woman had been suffering from an eye condition known as macular oedema, which was caused by retinal vein occlusion. Her doctor prescribed intraocular injections of bevacizumab, which is known as an anti-angiogenic factor (anti-VEGF) and sold under the brand name, Avastin. Avastin is used to treat various metastatic forms of cancer, and is not approved for intraocular treatment. Another anti-VEGF medicine, Lucentis (ranibizumab), was approved by the European Medicines Agency in 2007 as a treatment for two causes of macular oedema: retinal vein occlusion; and age-related macular degeneration. A newer drug named Eylea is also approved to treat these eye conditions. However, due to the 30-50 percent higher cost of these medicines, many ophthalmologists opt to  treat macular oedema patients off-label with Avastin. The World Health Organization and International Council of Ophthalmology back the off-label usage of the drug.

High Cost of Drugs a Factor in Prescribing

In 2012, a two-year clinical trial was published comparing Avastin and Lucentis. Researchers determined there were no statistical differences between the drugs in terms of efficacy or adverse side effects. The concerning difference between the two is the packaging and way they are administered. Based on its approval status, Lucentis is packaged in individual vials to eliminate the spread of microbial infections. Avastin, however, is packaged in 4ml and 16ml vials, and must be re-packaged into 1ml vials and mixed with sodium chloride. Transferring the fluid creates risk for contamination and compromises the drug’s sterility. Prior to her injections, the patient was briefed about Avastin’s use as a cancer treatment, but was told that ophthalmologists worldwide often prescribe the drug to treat eye conditions such as oedema. She was also warned of the rare risk of contracting endophthalmitis, an infectious and serious inflammation of the intraocular fluids.

The patient was administered four injections of Avastin over the course of several years. The first treatment, completed in a hospital operating room, was effective for about six years and significantly improved her condition. The second injection was performed in a sterilized doctor’s office. Though successful, the results lasted only six months. Shortly after the third injection was administered, the patient’s eyesight began to slowly deteriorate. A few months later, the fourth injection was given, at which point the woman’s eyesight deteriorated rapidly. The day following the fourth injection, she was diagnosed with endophthalmitis. Her ophthalmologist tried to treat her with intraocular antibiotics, but was unsuccessful. The next night, she was sent to a different doctor for vitrectomy surgery, but it was too late and her eyesight was lost. The patient later filed a medical malpractice lawsuit against her ophthalmologist, claiming medical negligence caused her to loss her vision.

Delaware Medical Malpractice Lawyers at McCann Dillon Jaffe & Lamb, LLC Fight for Those Harmed by Medication Errors

If you have been improperly treated by your doctor, or suffered harm because of a medication error, you may be entitled to compensation. Call McCann Dillon Jaffe & Lamb, LLC at 302-888-1221 or contact us online to arrange a free consultation with a qualified Delaware medical malpractice lawyer in our Wilmington, Delaware office.