Do Not Use Until 2007! Cefditoren (SPECRACEF) - Old Japanese Antibiotic Debuts in U.S.

Cefditoren (SPECTRACEF) was approved for sale by the Food and Drug Administration (FDA) in November 2001 making it the 23rd member of the cephalosporin family of antibiotics (semisynthetic relations of penicillin) and the 11th member of the sub-group known as third generation cephalosporins. The drug has been available in Japan since 1994.

We have invoked our Do Not Use Until Five Years After Release rule with this drug. The Five Year Rule is described in the box below.

The drug is being sold by TAP Pharmaceuticals Inc., a joint venture between Abbott Laboratories of Illinois and the Japanese firm Takeda Chemical Industries.

Cefditoren is approved only for use in adults and adolescents 12 years of age or older for the treatment of acute worsening of chronic bronchitis, sore throat or tonsillitis, and uncomplicated skin and skin structure infections caused by bacteria that will be killed by cefditoren. Company press releases indicate that TAP asked the FDA for approval for the treatment of sinus infection (acute bacterial sinusitis) as an approved use. But, the company failed to prove that cefditoren was of value in the treatment of sinus infection.

The drug’s professional product labeling or “package insert” contains two unusual contraindications for using cefditoren. First, the drug should not be used in patients with carnitine deficiency or congenital errors of normal metabolism that may result in a clinically significant carnitine deficiency. Cefditoren can cause a decrease in blood levels of carnitine of 39 percent to 63 percent depending on the dose of the drug. Progressive muscle weakness and breakdown of muscle (rhabdomyolysis) are associated with severe carnitine deficiency. However, neither of these adverse effects has been reported with the use of cefditoren at this time.

The second contraindication to using cefditoren is in patients who are truly allergic to milk products (not lactose intolerance which is an inability to breakdown lactose) because the drug contains sodium caseinate, a milk protein.

Cefditoren can interact with antacids containing magnesium and aluminum hydroxides such as MAALOX to reduce the amount of cefditoren in the blood. It is recommended that cefditoren not be taken with the histamine-2 blocker drugs commonly used for heartburn. Using these drugs with cefditoren at the same time will also reduce the blood levels of cefditoren. The histamine-2 blockers include cimetidine (TAGAMET) and ranitidine (ZANTAC).

The Medical Letter On Drugs and Therapeutics reviewed cefditoren in their January 21, 2002 issue. The Medical Letter editors concluded:

It offers no clinical advantage over cefdinir (OMNICEF) or cefpodoxime (VANTIN), but it costs less. Older drugs that have narrower spectrums of activity are as effective as cefditoren for the approved indications, and are less likely to promote emergence of resistance. Cephalexin (KEFLEX, and others), for example, would be a better choice for skin and soft tissue infection, and cefuroxime (CEFTIN) for bronchitis. Penicillin remains the drug of choice of streptococcal pharyngitis or tonsillitis.

The third generation cephalosporin sub-group of antibiotics is a mature market segment. Many of the drugs in this sub-group have been on the market for years and are available as lower cost generics. Since generic manufacturers do not advertise directly to physicians or consumers the promotion of a new brand name drug like cefditoren is essentially unopposed. Drug companies know if they can get a drug through the FDA’s outdated 40 year old standard for marketing drugs (not requiring new drugs to be better than old ones) they can make a financial killing on the strength of their advertising campaign.

What You Can Do

You should not take cefditoren for at least five years, until 2007. This drug offers no documented advantage over numerous other antibiotics that are equally or more effective than older antibiotics approved for the same uses.