미국 FDA는 2009년 12월에 다음과 같은 의약품의 안전성 표시 변경에 대하여 1) 박스 경고 (BW), 2) 배합 금기 (C), 3) 경고 (W), 4) 사전 주의 (P), 5) 부작용 (AR), 환자 약 포장 삽입/투약 안내 (PCI)로 구분하여 변경 조치했다.

변경내용중 △블랙박스(BW) 조치를 받은 의약품은 *Arixtra (fondaparinux sodium) injection *Fragmin (dalteparin sodium) injection * Innohep (tinzaparin sodium) injection *Lovenox (enoxaparin sodium) injection 등 4 품목으로 밝혀졌다.

이외 가장 많은 주치 내용은 △사잔 주의(P)로 무려 21품목 △경고(W) 12품목 △부작용(AR) 10품목 △배합금기(C) 9품목 △투약안내(PCI) 3품목 등으로 밝혀졌다.

작년말 조치된 내용

*Arixtra (fondaparinux sodium) injection: BW.
*Fragmin (dalteparin sodium) injection : BW.
*Innohep (tinzaparin sodium) injection : BW.
*Lovenox (enoxaparin sodium) injection : BW.

*Actonel (risedronate sodium) tablets: C. W. P
*Amlodipine besylate/ Benazepril hydrochloride capsule: C. P.
*Didronel (etidronate disodium) tablets: C. W. P
*Innopran XL (propranolol hydrochloride) extended release capsules: C. P.
*Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system: C. P. AR. PPI
*Spiriva HandiHaler (tiotropium bromide) inhalation powder: C. W.P

*Arranon (nelarabine) injection: W. P. AR
*Bicillin L-A (penicillin G benzathine) and Bicillin CR (penicillin G benzathine and penicillin *G procaine) injectable suspensions : W. P.

*Daytrana (methylphenidate) transdermal system : W. AR. MG
*Janumet (sitagliptin/metformin HCl) tablets *pancreatitis. : W. P. AR. PCI
*Januvia (sitagliptin) tablets *pancreatitis: W. P. AR. PCI
*Lexiscan (regadenoson) injection : W. P. AR.

*Seroquel (quetiapine fumarate) tablets : W. P.
*Seroquel XR (quetiapine fumarate) Extended-Release tablets : W. P.
*Topamax (topiramate) tablets and sprinkle capsules : W. P.
*Velcade (bortezomib) for injection : W. P.
*Verelan PM (verapamil hydrochloride) Extended-Release capsules : W. P. AR.

*Famvir (famciclovir) tablets : P
*Flomax (tamsulosin hydrochloride) capsules: P
*Qualaquin (quinine sulfate) capsules: P

*Zyvox (linezolid) tablets, IV injection, and oral suspension : P. AR.
*Invanz (ertapenem) injection: AR.
*Zestril (lisinopril) tablets : AR
*Ziac (bisoprolol fumarate and hydrochlorothiazide) tablets: AR.

(http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194965.htm)