An FDA alert was issued on June 17 about fraudulent Tamiflu being sold as “generic” Tamiflu on internet websites. The fake drugs do not contain the active ingredient in Tamiflu, oseltamivir. Instead, the ones purchased by FDA investigators actually contained cloxacillin, which is in the same class of antibiotics as penicillin.

The FDA is concerned that consumers with allergies to penicillin-based antibiotics could be injured by fraudulent generic Tamiflu, which does not warn that it contains cloxacillin. Reactions due to cloxacillin or penicillin allergies include a life-threatening condition known as anaphylaxis, which can involve symptoms including difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness or rapid or weak pulse.

Tamiflu (oseltamivir) was approved in the United States by the FDA in 1999 for the treatment and prevention of influenza. It is an orally active neuraminidase inhibitor that works by slowing the spread of the flu virus between cells in the body. Tamiflu has been heavily circulated for the treatment of H1N1 flu virus, also known as Swing Flu.

FDA drug safety inspectors purchased the generic Tamiflu from an internet website that claimed to be an online drug store. The website no longer appears to exist, FDA officials said. The drugs the agency received were shipped from India and are labeled “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” but they contain no oseltamivir. The foil backing says that the pills were “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.”

Despite the disappearance of the original website, FDA warns that other illegal online pharmacies may be selling fake generic Tamiflu as well. The FDA has never approved a generic version for Tamiflu, so all drugs claiming to be a generic version of the drugs are fake and should be avoided, the agency warns.

According to a recent report in The Lompoc Record, 17 year-old Gabrielle Corral was hospitalized in November after taking the medication, requiring intensive care after a painful rash developed behind her ears, on her lips and inside her mouth. Doctors diagnosed her condition as Stevens-Johnson Syndrome, which is commonly referred to as SJS.

For a time, the allergic reaction, which doctors believe was caused by GlaxoSmithKline’s Lamictal, left Corral in considerable pain, unable to see, speak or swallow. However, the teen is now out of the hospital and back in school after a number of surgeries to save her life and replace skin that was virtually burning from the inside out.

Stevens-Johnson Syndrome is a severe skin reaction that is known to occur as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.

Lamictal (lamotrigine) is approved by FDA for the treatment of epilepsy and bipolar disorder. GlaxoSmithKline, the manufacturer, has a “new warnings” alert on the their website for the drug, which leads to information about the potential risk of Stevens-Johnson Syndrome from Lamictal [PDF Medication Guide]. The warning indicates that signs of SJS are most likely to happen within the first two to eight weeks of Lamictal treatment. It also warns that children ages two to 16 are the most likely victims of Lamictal Stevens-Johnson Syndrome.

Corral required skin graphs which are still healing, lost 24 lbs. during her stay in intensive care and has to test which foods she can tolerate, but she returned to school at Lompoc High School and has rejoined her cheerleading squad. She is still healing and must wear sunglasses and heavy clothing to protect her skin while it heals.

Health care professionals in Canada have been asked not to use the batch of vaccines, which only involve a small portion of the 7.5 million doses GlaxoSmithKline indicates they distributed in the country. The batch was only distributed in Canada and the swine flu problems do not appear to have affected any batches in the United States.

GlaxoSmithKline has received at least six reports of severe allergic reactions to swine flu vaccine doses from the batch, and is conducting investigation into whether there is a problem with that particular batch. According to a spokesman for Canada’s health minister, most of doses from the batch have already been given out and the H1N1 vaccine allergic reactions could be a statistical anomaly.

Canadian health care professionals in six provinces that received the H1N1 vaccine batch on November 2 were alerted to the problem on November 18. Usually, only about two severe allergic reactions can be expected in a vaccine batch of similar size, according to a report in USA Today.

The reported swine flu vaccine reactions occurred immediately after injection, lasted for only a short time and do not appear to have caused any long-term health problems. The cases all included symptoms of anaphylaxis, which includes trouble breathing, tightness of the chest and swelling in the throat and mouth. Anaphylaxis is easily treatable, but can be fatal if untreated.

The label recommends that doctors test patients with small does of Dexferrum, an iron dextran injection, due to the possibility of anaphylactic shock, which can be fatal if not treated quickly. The new information will be added to an existing “black box” warning about the potential Dexferrum side effects.

Manufactured by American Regent, Dexferrum was first approved by the FDA in 1996. It is used to treat iron deficiency and anemia in patients for whom oral iron therapy is ineffective or not an option.

American Regent and FDA warned healthcare professionals that resuscitation equipment and trained personnel should be on hand whenever iron dextran injections are administered. Neither the FDA nor American Regent reported the number of fatalities which had occurred due to Dexferrum anaphylactic shock, however they did warn that fatal reactions have occurred even after test doses were given and appeared to be tolerated.

It is unclear whether INFeD, another iron dextran medication, is also affected by the labeling change.