Tuesday, February 28, 2006

Adderall and "Black Box" Warnings

The makers of Adderall, Shire Pharmaceuticals, says it wants more studies done to see id there are possible adverse effects from its ADHD drug. This came after the FDA advisory panel said such drugs for ADHD should carry a black box warning.
Shire said in a statement, "While we fully support full disclosure ad adequate warning, Shire believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events. Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that has not been supported by sufficient data."
Although the FDA doesn't have to follow the panel's recommendation, they will consider the highlighted warning by a black box, which is the most serious typed for prescription drugs. Panel members stated that because Adderall and other ADHD drugs are amphetamines or chemically similar, they can raise blood pressure which is often a precursor to severe heart problems. The FDA states that right now about 1 million adults and 2 million children get ADHD prescriptions every month.
Shire says it already carries a black box warning stating misuse may lead to sudden death or serious cardiovascular events and believe no other warning is needed. Some believe it should say use not misuse of this product can cause sudden death.

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