Published: 6 June 2024
Publications
Recent data sheet updates: important new safety information
Published: 6 June 2024
Prescriber Update 45(2): 47–48
June 2024
Table 1 below provides a list of data sheets recently updated with important new safety information. Note that this is not a comprehensive list of all recently updated data sheets, nor does it describe all changes to a particular data sheet.
To find out if sponsors have made any changes to their data sheets, see Section 10 ‘Date of revision of the text’ (at the end of each data sheet). Search for a data sheet
See also the New/updates to data sheets and CMIs page on the Medsafe website.
Table 1: Recently updated data sheets (by active ingredient): important new safety information
Click on the specific medicine to open the data sheet.
| Active ingredient(s): | Data sheet updates | |
|---|---|---|
| Medicine(s) | Section* | Summary of new safety information |
| Benzathine benzylpenicillin Bicillin L-A |
4.8 | Kounis syndrome |
| Clindamycin Dalacin C capsule |
4.2 | To avoid oesophageal irritation, take with a full glass of water and no less than 30 minutes before lying down |
| Docetaxel DBL Docetaxel |
4.6 | Pregnancy: women of childbearing potential should use effective contraception during treatment and for at least 2 months after the last dose; male patients with female partners of childbearing potential should use effective contraception during treatment and for at least 4 months after the last dose |
| Etanercept Enbrel |
4.6 | Live vaccines can be considered for infants 16 weeks after stopping breastfeeding |
| Ezetimibe Ezetimibe Sandoz |
4.3 | Concomitant use is contraindicated with: fenofibrate in patients with gallbladder disease; a statin during pregnancy and lactation; a statin in patients with active liver disease or unexplained persistent elevations in serum transaminases |
| 4.8 | Nausea, arthralgia, drug-induced liver injury, increased creatine phosphokinase (CPK), elevations of liver transaminases, severe cutaneous adverse reactions (SCAR), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) | |
| Infliximab Remicade |
4.8 | Weight increased |
| Liraglutide Victoza Saxenda |
4.8 | Delayed gastric emptying, urinary tract infection, intestinal obstruction including ileus |
| Methylphenidate Ritalin, Ritalin LA |
4.4 | Acute angle closure glaucoma, increased intraocular pressure and glaucoma |
| 4.8 | Erectile dysfunction, increased intraocular pressure | |
| Osimertibinib Tagrisso |
4.8 | Skin hyperpigmentation |
| Pembrolizumab Keytruda |
4.4 | Other immune-mediated adverse reactions: haemolytic anaemia, exocrine pancreatic insufficiency |
| Pirfenidone Esbriet |
4.4 | SCAR, including SJS, TEN and DRESS |
| 4.8 | ||
| Rifampicin + isoniazid Rifinah |
4.5 | Rifampicin interaction with caspofungin |
| Ropivacaine Naropin |
4.4 | Horner’s syndrome |
| Secukinumab Cosentyx |
4.4 | Hypersensitivity reactions: angioedema. Eczematous eruptions |
| 4.8 | Dermatitis, dermatitis exfoliative generalised, angioedema | |
| Silver sulfadiazine Flamazine |
4.4 | SJS, TEN |
| 4.8 | ||
| Tacrolimus Tacrolimus Sandoz |
4.4 | Thrombotic microangiopathy |
| 4.5 | Increase tacrolimus blood levels: concomitant use with hepatitis C virus (HCV) protease inhibitors, letermovir or amiodarone may require decreased tacrolimus doses. Decrease tacrolimus blood levels: caspofungin | |
| 4.8 | Cytomegalovirus (CMV) infection, thrombotic microangiopathy | |
* Data sheet sections listed in the table are: 4.2: Dose and method of administration; 4.3: Contraindications; 4.4: Special warnings and precautions for use; 4.5: Interaction with other medicines and other forms of interaction; 4.6: Fertility, pregnancy and lactation; 4.8: Undesirable effects
