US Pharm. 2006;7:72.

Tysabri Marketing Allowed to Resume
The Biogen-Idec drug Tysabri (natalizumab) may be marketed subject to a special restricted distribution program, FDA announced in June. The monoclonal antibody used to reduce flare-ups in patients with relapsing forms of multiple sclerosis (MS) was withdrawn from the market in February 2005, three months after its approval, after three patients in the drug's clinical trials developed progressive multifocal leukoencephalopathy (PML).

To reduce the risk of future patients developing the serious and rare viral infection of the brain, patients who take Tysabri must comply with a mandatory patient registration requirement and undergo periodic follow-up designed to identify PML cases as early as possible. To facilitate this, Biogen-Idec created a risk management plan called the TOUCH Prescribing Program.

Because FDA does not know enough about how Tysabri's use with other immune-modifying drugs could affect PML risk, Tysabri is indicated for use as monotherapy or for patients who have not responded adequately to or cannot tolerate other MS treatments.


 

FDA Strengthens Counterfeit Drug Fight
Aiming to ensure the safety of the U.S. drug supply, FDA recently announced new measures designed to protect against counterfeit drugs. The measures, described in a report released by FDA's Counterfeit Drug Task Force, emphasize certain regulatory actions and the use of new technologies.

Specifically, FDA will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation on a drug's "pedigree." The agency also encourages distributors to adopt radio-frequency identification technology, particularly for products most susceptible to counterfeiting and diversion. FDA's report is available at www.fda.gov/counterfeit.

 

FDA/EPA Seafood Advisory Still Current
FDA and the Environmental Protection Agency (EPA) recently assured consumers that its 2004 advisory "What You Need to Know About Mercury in Fish and Shellfish" remains current and that they stand by the advice contained in it. The advisory provides information on safe consumption of fish and shellfish for women who might become pregnant, who are pregnant, or who are nursing, as well as for young children.

Since fish and shellfish are an important part of a healthy diet, FDA and EPA recommend that women and young children include them regularly in their diet. However, to reduce exposure to mercury, the agencies recommend that women and young children abide by the following guidelines:

1. Do not eat shark, swordfish, king mackerel, or tilefish, as they have high mercury levels;
2. Eat up to 12 ounces per week of fish and shellfish that are lower in mercury (e.g., shrimp, canned light tuna, salmon, pollock, catfish), with only 6 ounces comprising albacore tuna; and
3. Check local advisories about the safety of fish caught in local waters. If no information is available, eat up to 6 ounces of such fish per week and do not consume any other fish during that week.

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